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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01676077
Registration number
NCT01676077
Ethics application status
Date submitted
28/08/2012
Date registered
30/08/2012
Date last updated
26/07/2022
Titles & IDs
Public title
Clinical Outcome Study for Dysferlinopathy
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Scientific title
International Clinical Outcome Study for Dysferlinopathy
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Secondary ID [1]
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85750
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Universal Trial Number (UTN)
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Trial acronym
Jain COS
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Dysferlinopathy
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LGMD2B Now Classified as LGMDR2
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Miyoshi Myopathy
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Critically Ill Adults Ventilated >24 Hours in Intensive Care
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COPD
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Cancer
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Condition category
Condition code
Musculoskeletal
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Other muscular and skeletal disorders
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Cancer
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Kidney
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Treatment: Other - Radiotherapy
Patients with a genetically confirmed dysferlinopathy -
Placebo comparator: Portable Oxygen Cylinder - Portable Oxygen Cylinder
Active comparator: Portable Oxygen Concentrator - Portable Oxygen Concentrator
Experimental: Radiotherapy - The interventional treatment will be prescribed as a 2-tiered dose scheduled dependant of target size.
For lesions \<5cm, a single fraction of 26 Gy will be prescribed. For lesions =5cm a fractionated course of 15Gy by 3 fractions will be prescribed, delivered at least 48 hours apart.
Treatment: Other: Radiotherapy
The investigational treatment will be prescribed as a 2-tiered dose scheduled dependant on target size.
For lesions \<5cm, a single fraction of 26Gy will be prescribed. For lesions =5cm a fractionated course of 14Gy by 3 fractions will be prescribed, delivered at least 48 hours apart.
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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VARC-2 Composite Safety Endpoint
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Assessment method [1]
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The primary endpoint is a VARC-2 Composite. It comprises of
1. All cause mortality
2. All stroke
3. Life-threatening bleeding
4. Acute kidney injury - Stage 3 (including renal replacement therapy)
5. Coronary artery obstruction requiring intervention
6. Major vascular complications
7. Valve related dysfunction (requiring repeat procedure)
A composite endpoint is an endpoint that is a combination of multiple components.
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Timepoint [1]
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30 days
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Primary outcome [2]
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North Star assessment for limb girdle-type muscular dystrophies (NSAD)
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Assessment method [2]
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A functional scale that will be used to measure motor performance in individuals with LGMD
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Timepoint [2]
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24 months
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Primary outcome [3]
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Best level of activity in ICU
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Assessment method [3]
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Highest level of activity (11 point scale) including:
unknown nothing (lying in bed, passive stretches) sitting in bed, active exercises in bed moved to chair (via hoist, slide etc but no standing) sitting over edge of bed standing transferring bed to chair marching on spot (at bedside) walking with assistance of 2 or more people walking with assistance of 1 person walking independently with a gait aid walking independently without a gait aid
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Timepoint [3]
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ICU stay (average 7 days)
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Primary outcome [4]
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Dosage of the best level of activity
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Assessment method [4]
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The time spent performing the best level of activity and the number of times it is achieved
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Timepoint [4]
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Intensive care unit stay (average 7 days)
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Primary outcome [5]
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Time to standing in ICU
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Assessment method [5]
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The number of days in ICU before a patient can stand
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Timepoint [5]
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Intensive care stay (average 7 days)
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Primary outcome [6]
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Quality of life as measured through Chronic Respiratory Questionnaire
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Assessment method [6]
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only two subdomains of the Chronic Respiratory Questionnaire (CRQ) were used: the Shortness of Breath (SoB) domain and the Mastery domain
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Timepoint [6]
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One month
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Primary outcome [7]
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The number of patients who complete prescribed treatment.
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Assessment method [7]
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This is defined as patients who successfully receive the treatment plan as prescribed, achieving all nominated dose constraints, and are able to tolerate the treatment(s)
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Timepoint [7]
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After 24 months
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Secondary outcome [1]
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All Cause Mortality
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Assessment method [1]
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Timepoint [1]
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30 days
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Secondary outcome [2]
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All Cause Mortality
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Assessment method [2]
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Timepoint [2]
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12 months
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Secondary outcome [3]
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Best level of activity at hospital discharge
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Assessment method [3]
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Highest level of activity (11 point scale) including:
unknown nothing (lying in bed, passive stretches) sitting in bed, active exercises in bed passively moved to chair (pat slide, hoist but no standing) sitting over edge of bed standing transferring bed to chair marching on spot (at bedside) walking with assistance of 2 or more people walking with assistance of 1 person walking independently with a gait aid walking independently without a gait aid
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Timepoint [3]
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Hospital stay (median days 14)
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Secondary outcome [4]
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Time to first sit out of bed
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Assessment method [4]
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The number of days until the patient can sit out of bed
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Timepoint [4]
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ICU stay (average 7 days)
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Secondary outcome [5]
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Barriers to mobilisation
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Assessment method [5]
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Factors that may have been a barrier to mobilizing patients in the ICU
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Timepoint [5]
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Intensive care unit stay (average 7 days)
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Secondary outcome [6]
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Mobilization related adverse events
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Assessment method [6]
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Adverse events that occured during patient mobilization such as an unplanned extubation or a fall to the floor
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Timepoint [6]
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Intensive care unit stay (average 7 days)
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Secondary outcome [7]
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Time to first physiotherapy
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Assessment method [7]
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The number of days in intensive care before the patient was reviewed by a physiotherapist
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Timepoint [7]
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Intensive care unit stay (average 7 days)
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Secondary outcome [8]
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Mechanical ventilation free days
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Assessment method [8]
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The number of mechanical ventilation free days to day 28
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Timepoint [8]
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28 days
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Secondary outcome [9]
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Intensive care unit free days
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Assessment method [9]
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The number of days the patient spent out of ICU to day 28 (if dead = 0)
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Timepoint [9]
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Day 28
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Secondary outcome [10]
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90 day mortality
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Assessment method [10]
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The mortality at day 90
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Timepoint [10]
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90 days
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Secondary outcome [11]
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Health related quality of life at 6 months
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Assessment method [11]
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Health related quality of life reported via telephone interview at 6 months using the EuroQoL EQ5D
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Timepoint [11]
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6 months
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Secondary outcome [12]
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Patient Preference
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Assessment method [12]
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Five 7-point Likert Scales, ranging from 1 (none of the time) to 7 (all of the time) on portability ("the equipment was portable enough for my needs"), operation ("I was able to set up and operate the equipment properly"), noise ("Noise from the equipment affected me"), comprehension ("I was able to understand the functions of the equipment, e.g. alarms") and duration ("The oxygen lasted long enough for me to perform my normal activities"). Furthermore, patients were asked to provide comments on use of the POCs and the Cylinders after they completed the respective stage of the trial.
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Timepoint [12]
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One month
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Secondary outcome [13]
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Cost effectiveness of portable oxygen concentrator compared to cylinder
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Assessment method [13]
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Economic assessment based on treatment cost, readmission data and hospital utilisation
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Timepoint [13]
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one month
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Secondary outcome [14]
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Quality of life as measured through AQoL-8D
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Assessment method [14]
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Assessment of Quality of Life (AQoL)-8D Multi-Attribute Utility Instrument
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Timepoint [14]
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One month
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Secondary outcome [15]
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Toxicity of SBRT in study patients measured using CTCAE V4.0
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Assessment method [15]
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Specific toxicities will include, but are not limited to;
* Gastrointestinal (Nausea, vomiting, diarrhoea, acute ulceration)
* Pulmonary (atelectasis, cough, dyspnoea, hypoxia, pleural effusion, fibrosis)
* Skin/chest wall (radiation dermatitis, rib fracture)
* Kidney (acute renal dysfunction) Freedom from severe toxicity will be reported asn defined as: time from treatment delivery until first recorded grade 4, or 5 toxicity as measured by CTCAE V4.0.
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Timepoint [15]
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Between 2-4 weeks after radiotherapy and 3 monthly for 12 months
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Secondary outcome [16]
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Efficacy of stereotactic radiosurgery
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Assessment method [16]
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Effective SBRT is defined as a treatment which results in local control at 1 year after treatment. Local control is defined as lack of progression of the target lesion as measured by RECIST criteria. RECIST criteria are a CT evaluation of change in tumour size.
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Timepoint [16]
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1 year after treatment
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Secondary outcome [17]
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Feasibility of using Diffusion weighted-MRI for response assessment.
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Assessment method [17]
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Feasibility will be measured by the quality of image of the diffusion weighted-MRI recorded by the investigating radiologists.
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Timepoint [17]
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At Baseline, 14 days (+/-3 days) and at the definitive response assessment (70days +/-10days)
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Eligibility
Key inclusion criteria
- Confirmed diagnosis of dysferlinopathy proven by a) two (predicted) pathogenic dysferlin mutations, b) one (predicted) pathogenic dysferlin mutation and absent dysferlin protein on muscle immunoblot, or c) one (predicted) pathogenic dysferlin mutation and dysferlin protein level =20% of normal level determined by blood monocyte testing. Mutations will be checked for pathogenicity via the UMD bioinformatics tools and and by checking the literature and mutation /variant databases.
NOTE: Contact Sarah Shira at the Jain Foundation for help with diagnosis at +1 425 882 1492
* Ambulant with or without aids; or full-time wheelchair user, i.e. non-ambulant; with the ratio 2:1 between recruited ambulant and recruited non-ambulant patients.
* All ages = 10 years of age.
* Ability to perform assessments (there will be different assessments for ambulant and non-ambulant patients).
* Ability to attend scheduled investigations.
* Informed consent to participate in the clinical outcome study.
NOTE: Funds are available to cover necessary hotel stays and travel costs to the study centres for the participant and a helper (if needed).
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Minimum age
10
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Known current or planned medical or other interventions that might interfere with the possibility to undertake the planned tests.
* Other concomitant pathology that in the view of the investigator would jeopardise the ability to take part in the protocol.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
UNKNOWN
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/03/2024
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Recruitment hospital [2]
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Macquarie Unversity Hospital - Macquarie Park
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Recruitment hospital [3]
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Prince of Wales Hospital - Randwick
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Recruitment hospital [4]
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Royal North Shore Hospital - St. Leonards
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Recruitment hospital [5]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [6]
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Royal Adelaide Hospital - Adelaide
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Recruitment hospital [7]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [8]
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The Alfred Hospital - Melbourne
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Recruitment hospital [9]
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St Vincent's Hospital - MELBOURNE - Melbourne
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Recruitment hospital [10]
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Royal Melbourne Hospital - Parkville
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Recruitment hospital [11]
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Royal Perth Hospital/Fiona Stanley Hospital - Perth
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Recruitment hospital [12]
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The Alfred - Melbourne
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Recruitment hospital [13]
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The Queen Elizabeth Hospital - Woodville Road, Woodville
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Recruitment hospital [14]
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Peter MacCallum Cancer Centre - East Melbourne
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2109 - Macquarie Park
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Recruitment postcode(s) [3]
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2031 - Randwick
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Recruitment postcode(s) [4]
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2065 - St. Leonards
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Recruitment postcode(s) [5]
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4032 - Chermside
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Recruitment postcode(s) [6]
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5000 - Adelaide
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Recruitment postcode(s) [7]
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5042 - Bedford Park
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Recruitment postcode(s) [8]
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3004 - Melbourne
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Recruitment postcode(s) [9]
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3065 - Melbourne
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Recruitment postcode(s) [10]
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3050 - Parkville
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Recruitment postcode(s) [11]
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6000 - Perth
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Recruitment postcode(s) [12]
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3104 - Melbourne
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Recruitment postcode(s) [13]
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5022 - Woodville Road, Woodville
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Recruitment postcode(s) [14]
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3002 - East Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Missouri
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Country [3]
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United States of America
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State/province [3]
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New York
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Country [4]
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United States of America
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State/province [4]
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North Carolina
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Country [5]
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United States of America
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State/province [5]
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Ohio
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Country [6]
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Chile
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State/province [6]
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Santiago
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Country [7]
0
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Denmark
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State/province [7]
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Copenhagen
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Country [8]
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France
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State/province [8]
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Paris
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Country [9]
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Italy
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State/province [9]
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Padova
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Country [10]
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Japan
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State/province [10]
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Tokyo
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Country [11]
0
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Korea, Republic of
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State/province [11]
0
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Busan
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Country [12]
0
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Spain
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State/province [12]
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Barcelona
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Country [13]
0
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Spain
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State/province [13]
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San Sebastián
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Country [14]
0
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Spain
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State/province [14]
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Sevilla
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Country [15]
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United Kingdom
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State/province [15]
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Newcastle upon Tyne
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Country [16]
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New Zealand
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State/province [16]
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Wellington
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Funding & Sponsors
Primary sponsor type
Other
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Name
Newcastle-upon-Tyne Hospitals NHS Trust
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Jain Foundation
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Pacific Clinical Research Group
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Address [2]
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Country [2]
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Other collaborator category [3]
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Other
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Name [3]
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Intensive Care Foundation, Australia
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Address [3]
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Country [3]
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Ethics approval
Ethics application status
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Summary
Brief summary
The "Clinical Outcome Study for Dysferlinopathy" is being performed in centres in Europe (UK- Newcastle; Spain- Barcelona, Sevilla; San Sebastian;Denmark, Copenhagen, Italy- Padova; France- Paris,), USA (Charlotte, NC; Columbus, OH; St.Louis, MO, Stanford CA, Irvine CA and Columbia NY), Chile (Santiago) Japan (Tokyo) and South Korea (Pusan). Oversight is provided by Newcastle upon Tyne Hospitals Trust. Funding for this study is being provided by the Jain Foundation, a non-profit foundation dedicated to finding therapies for dysferlinopathies(LGMD2b/Miyoshi). The aim of this "Clinical Outcome Study" is to determine the clinical outcome measures required for future clinical trials, characterize the disease progression of dysferlinopathy and collect biological samples for the identification of disease markers that are needed to non-invasively monitor the disease during clinical trials. Without this information, effective clinical trials cannot be performed. This study is recruiting a large number of genetically confirmed dysferlinopathy patients aged 10 years or older, who are ambulant or non-ambulant. The study has reopened for a further two years (COS2). Participants will be assessed at 4 further visits over 2 years via medical, physiotherapy, and MRI/MRS assessments, as well as standard blood tests. Optionally, the participants can donate blood samples and a skin sample for use in the identification of disease markers and other approved research. There is a sub-study running in MRI at selected sites.
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Trial website
https://clinicaltrials.gov/study/NCT01676077
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Trial related presentations / publications
Moore U, Jacobs M, James MK, Mayhew AG, Fernandez-Torron R, Feng J, Cnaan A, Eagle M, Bettinson K, Rufibach LE, Lofra RM, Blamire AM, Carlier PG, Mittal P, Lowes LP, Alfano L, Rose K, Duong T, Berry KM, Montiel-Morillo E, Pedrosa-Hernandez I, Holsten S, Sanjak M, Ashida A, Sakamoto C, Tateishi T, Yajima H, Canal A, Ollivier G, Decostre V, Mendez JB, Sanchez-Aguilera Praxedes N, Thiele S, Siener C, Shierbecker J, Florence JM, Vandevelde B, DeWolf B, Hutchence M, Gee R, Prugel J, Maron E, Hilsden H, Lochmuller H, Grieben U, Spuler S, Tesi Rocha C, Day JW, Jones KJ, Bharucha-Goebel DX, Salort-Campana E, Harms M, Pestronk A, Krause S, Schreiber-Katz O, Walter MC, Paradas C, Hogrel JY, Stojkovic T, Takeda S, Mori-Yoshimura M, Bravver E, Sparks S, Diaz-Manera J, Bello L, Semplicini C, Pegoraro E, Mendell JR, Bushby K, Straub V; Jain COS Consortium. Assessment of disease progression in dysferlinopathy: A 1-year cohort study. Neurology. 2019 Jan 28;92(5):e461-e474. doi: 10.1212/WNL.0000000000006858. Diaz-Manera J, Fernandez-Torron R, LLauger J, James MK, Mayhew A, Smith FE, Moore UR, Blamire AM, Carlier PG, Rufibach L, Mittal P, Eagle M, Jacobs M, Hodgson T, Wallace D, Ward L, Smith M, Stramare R, Rampado A, Sato N, Tamaru T, Harwick B, Rico Gala S, Turk S, Coppenrath EM, Foster G, Bendahan D, Le Fur Y, Fricke ST, Otero H, Foster SL, Peduto A, Sawyer AM, Hilsden H, Lochmuller H, Grieben U, Spuler S, Tesi Rocha C, Day JW, Jones KJ, Bharucha-Goebel DX, Salort-Campana E, Harms M, Pestronk A, Krause S, Schreiber-Katz O, Walter MC, Paradas C, Hogrel JY, Stojkovic T, Takeda S, Mori-Yoshimura M, Bravver E, Sparks S, Bello L, Semplicini C, Pegoraro E, Mendell JR, Bushby K, Straub V; Jain COS Consortium. Muscle MRI in patients with dysferlinopathy: pattern recognition and implications for clinical trials. J Neurol Neurosurg Psychiatry. 2018 Oct;89(10):1071-1081. doi: 10.1136/jnnp-2017-317488. Epub 2018 May 7. Moore UR, Jacobs M, Fernandez-Torron R, Jang J, James MK, Mayhew A, Rufibach L, Mittal P, Eagle M, Cnaan A, Carlier PG, Blamire A, Hilsden H, Lochmuller H, Grieben U, Spuler S, Tesi Rocha C, Day JW, Jones KJ, Bharucha-Goebel DX, Salort-Campana E, Harms M, Pestronk A, Krause S, Schreiber-Katz O, Walter MC, Paradas C, Hogrel JY, Stojkovic T, Takeda S, Mori-Yoshimura M, Bravver E, Sparks S, Diaz-Manera J, Bello L, Semplicini C, Pegoraro E, Mendell JR, Bushby K, Straub V. Teenage exercise is associated with earlier symptom onset in dysferlinopathy: a retrospective cohort study. J Neurol Neurosurg Psychiatry. 2018 Nov;89(11):1224-1226. doi: 10.1136/jnnp-2017-317329. Epub 2018 Jan 29. No abstract available. TEAM Study Investigators; Hodgson C, Bellomo R, Berney S, Bailey M, Buhr H, Denehy L, Harrold M, Higgins A, Presneill J, Saxena M, Skinner E, Young P, Webb S. Early mobilization and recovery in mechanically ventilated patients in the ICU: a bi-national, multi-centre, prospective cohort study. Crit Care. 2015 Feb 26;19(1):81. doi: 10.1186/s13054-015-0765-4. Tipping CJ, Bailey MJ, Bellomo R, Berney S, Buhr H, Denehy L, Harrold M, Holland A, Higgins AM, Iwashyna TJ, Needham D, Presneill J, Saxena M, Skinner EH, Webb S, Young P, Zanni J, Hodgson CL. The ICU Mobility Scale Has Construct and Predictive Validity and Is Responsive. A Multicenter Observational Study. Ann Am Thorac Soc. 2016 Jun;13(6):887-93. doi: 10.1513/AnnalsATS.201510-717OC. Pham D, Thompson A, Kron T, Foroudi F, Kolsky MS, Devereux T, Lim A, Siva S. Stereotactic ablative body radiation therapy for primary kidney cancer: a 3-dimensional conformal technique associated with low rates of early toxicity. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1061-8. doi: 10.1016/j.ijrobp.2014.07.043. Epub 2014 Oct 13.
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Public notes
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Contacts
Principal investigator
Name
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Volker Straub
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Address
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Newcastle University
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Type
Citations or Other Details
Journal
TEAM Study Investigators; Hodgson C, Bellomo R, Be...
[
More Details
]
Results not provided in
https://clinicaltrials.gov/study/NCT01676077
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