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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04460768
Registration number
NCT04460768
Ethics application status
Date submitted
3/07/2020
Date registered
8/07/2020
Titles & IDs
Public title
An INternational Frontline Ovarian Cancer Real World Management Study
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Scientific title
A Multicountry, Multicenter, Retrospective Study Evaluating the Patient Characteristics, Disease Burden, Treatment Patterns, and Patient Journey of Advanced Epithelial Ovarian Cancer Patients: A Korean, Taiwanese, and Australian Secondary Database Study
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Secondary ID [1]
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D0817R00028
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Universal Trial Number (UTN)
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Trial acronym
INFORM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ovarian Neoplasms
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Condition category
Condition code
Cancer
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Ovarian and primary peritoneal
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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
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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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Progression-free survival
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Assessment method [1]
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In first line setting - length of time from diagnosis to first progression, death, or last follow-up. In second line setting, length of time from start of second line therapy until patient has disease progression, death, or last follow-up.
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Timepoint [1]
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Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
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Secondary outcome [1]
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Platinum free interval
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Assessment method [1]
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The number of months elapsed from the last day of platinum chemotherapy for first line of treatment to the date of diagnosis of disease recurrence or date of last follow-up if the patient did not recur during the study period
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Timepoint [1]
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Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
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Secondary outcome [2]
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Time to progression
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Assessment method [2]
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The length of time from the date of cancer diagnosis or the start of anti-cancer treatment until the cancer starts to get worse or spread to other parts of the body.
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Timepoint [2]
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Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
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Secondary outcome [3]
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Duration of treatment
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Assessment method [3]
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The length of time from the start of anti-cancer treatment to end of anti-cancer treatment
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Timepoint [3]
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Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
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Secondary outcome [4]
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Time to first subsequent treatment
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Assessment method [4]
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The length of time from the date of cancer diagnosis to the start of cancer treatment after cancer progression
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Timepoint [4]
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Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
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Secondary outcome [5]
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Overall survival
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Assessment method [5]
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Duration from the index date to the date of death (if available)
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Timepoint [5]
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Retrospective study of patients diagnosed between the period Jan 2014-Dec 2018
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Eligibility
Key inclusion criteria
* Female subjects above the age of 18
* Patients with a confirmed diagnosis of advanced-stage (FIGO III/IV) epithelial (Serous [high or low grade], mucinous, endometrioid, clear cell, mixed, and others) ovarian cancer between the period Jan 2014 and Dec 2018, provided at least 12 months data is available (not mandatory to be ovarian cancer related) as a proxy of healthcare use prior to the diagnosis of advanced-stage epithelial ovarian cancer
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Minimum age
No limit
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Patients being included in interventional clinical trials with PARPi for the treatment of advanced-stage high-grade epithelial ovarian cancer treatment during the study period
* Patients with early stage disease (FIGO Stage I, IIA, IIB, or IIC)
* Other malignancies within the past five years, except adequately treated non-melanoma skin cancer; curatively treated in situ cancer of the cervix; ductal carcinoma in situ; stage 1, grade 1 endometrial carcinoma; or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for =5 years. Patients with a history of localized breast cancer may have been eligible, provided they completed their adjuvant chemotherapy more than three years prior to registration, and remained free of recurrent or metastatic disease
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
27/06/2020
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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
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Actual
10/11/2020
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Sample size
Target
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Accrual to date
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Final
989
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Research Site - Melbourne
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Recruitment postcode(s) [1]
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D0817R00028 - Melbourne
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Recruitment outside Australia
Country [1]
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Korea, Republic of
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State/province [1]
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Seoul
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Country [2]
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Taiwan
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State/province [2]
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New Taipei City
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Country [3]
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Taiwan
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State/province [3]
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Taipei City
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AstraZeneca
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The current study aims to analyze the existing secondary databases from Korea (Sungkyunkwan University, Samsung Medical Center, Seoul), Taiwan (National Taiwan University, Chang-Gung Medical Foundation Linkou Branch and Mackay Memorial Hospital), and Australia (Australian Ovarian Cancer Study \[AOCS\]) to leverage the already available data in the real-world setting to review the current standard of care in advanced epithelial ovarian cancer cases. The collected data will help provide the required information for assessing the unmet treatment needs in this patient group. The data will also provide the needed information to support any reimbursement activity needed for future novel therapies in this patient group
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Trial website
https://clinicaltrials.gov/study/NCT04460768
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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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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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
No IPD will be shared.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04460768