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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05839379
Registration number
NCT05839379
Ethics application status
Date submitted
20/04/2023
Date registered
3/05/2023
Titles & IDs
Public title
Targeted Pediatric High-Grade Glioma Therapy
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Scientific title
Molecularly-Guided Phase II Umbrella Trial for Children, Adolescents, and Young Adults Newly Diagnosed With High-Grade Glioma, Including Diffuse Intrinsic Pontine Glioma
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Secondary ID [1]
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CONNECT TarGeT-SCR
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
High Grade Glioma
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Diffuse Intrinsic Pontine Glioma
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Anaplastic Astrocytoma
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Glioblastoma
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Glioblastoma Multiforme
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Diffuse Midline Glioma, H3 K27M-Mutant
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Metastatic Brain Tumor
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WHO Grade III Glioma
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WHO Grade IV Glioma
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Condition category
Condition code
Cancer
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Brain
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Cancer
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Children's - Brain
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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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Molecular profiling
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Assessment method [1]
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Utilize molecular, clinical, and histopathologic data to assess eligibility for specific biologically-guided treatment subprotocols among pediatric, adolescent and young adult patients with newly diagnosed HGG, including DIPG.
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Timepoint [1]
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4 years
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Primary outcome [2]
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Feasibility of molecular profiling and enrollment to a TarGeT treatment protocol
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Assessment method [2]
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Determine the percent of pediatric, adolescent, and young adult patients newly diagnosed with HGG, including DIPG, who undergo comprehensive molecular characterization across clinical molecular testing laboratories at CONNECT sites and begin treatment on a TarGeT treatment subprotocol within 10 calendar days of starting radiation therapy (RT) (if treatment involves an agent given concurrently with RT) or within 35 days of completion of RT (if treatment involves adjuvant maintenance therapy).
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Timepoint [2]
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4 years
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Secondary outcome [1]
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Genomic Research
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Assessment method [1]
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Increase knowledge of the genomic and immunologic landscape of newly-diagnosed pediatric and young adult HGGs, including DIPG, through comprehensive molecular characterization.
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Timepoint [1]
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6 years
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Secondary outcome [2]
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Germline susceptibility testing
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Assessment method [2]
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Determine the frequency and spectrum of germline cancer susceptibility mutations in children and young adults with HGG and DIPG and assess the feasibility of return of those results.
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Timepoint [2]
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4 years
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Secondary outcome [3]
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Biobanking
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Assessment method [3]
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Prospectively collect tumor tissue from diagnostic biopsy/resection as well as baseline peripheral blood and cerebrospinal fluid (CSF) samples for the CONNECT biorepository to be used in correlative research for the present trial as well as future studies.
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Timepoint [3]
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4 years
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Eligibility
Key inclusion criteria
1. Age: Patients must be =12 months and =30 years of age at the time of enrollment onto this screening protocol.
2. Diagnosis: Patients with newly diagnosed HGG, including DIPG are eligible. The diagnosis of HGG must have been confirmed by local pathology review. for the diagnosis of DIPG, patients must have a tumor with pontine epicenter and diffuse involvement of at least 2/3 of the pons, with histopathology consistent with diffuse WHO grade 2-4 glioma (eg, diffuse astrocytoma, anaplastic astrocytoma, glioblastoma, H3K27-altered diffuse midline glioma). For all other tumors, histologic grade must be WHO grade 3-4.
3. Disease Status: There are no disease status requirements for enrollment.
* Measurable disease is not required. Patients without measurable disease are eligible.
* Patients with metastatic/disseminated or multifocal disease or gliomatosis cerebri are eligible.
* Patients with a primary spinal tumor are eligible.
* Patients with secondary, radiation related HGG are eligible.
4. Prior Therapy for HGG: Surgery, radiation, and/or dexamethasone are permissible. Temozolomide concurrent with radiation is permissible, but not recommended. No other prior anticancer therapy for HGG will be allowed.
Timing from surgery to start of RT: For patients who have started RT, radiation must have started within 31 days of definitive surgery or biopsy (if patient had two surgeries, radiation must have started within 31 days from second surgery).
5. Tumor Sample Availability OR results from previous molecular profiling/targeted sequencing
* If a patient screens through OPTION #1, tumor sample in addition to normal comparator tissue (peripheral blood or saliva) must be submitted for comprehensive molecular screening at the time of screening enrollment.
* If a patient screens through OPTIONS #2 or #3, results from previously performed molecular profiling must be submitted following enrollment. It is highly recommended that results be uploaded within 7 days of enrollment (if results are available at time of enrollment) or within 7 days of results becoming available (if pending at time of enrollment) to allow adequate time for central review.
6. Informed Consent: All patients and/or their parents or legally authorized representatives must sign a written informed consent. Assent, when appropriate, will be obtained according to institutional guidelines.
7. Enrollment timeline: Patients are eligible to enroll on the TarGeT-SCR anytime between diagnosis and the following specific timepoints post completion of RT
* Patients screening through OPTION #1 are eligible to enroll anytime between diagnosis and 10 days post RT.
* Patients screening through OPTIONS #2 or #3 are eligible to enroll anytime between diagnosis and 21 days post RT.
However, it is important to note the following:
* For treatment protocols that include targeted therapy administered concurrently with RT, patients must start treatment within 10 calendar days of starting RT.
* For treatment protocols that only include maintenance/adjuvant therapy (no systemic therapy given concurrently with radiation), patients must start treatment by 35 days post RT
#SCREENING OPTIONS
* OPTION1: Molecular screening through CONNECT TarGeT Clinical Testing Laboratories
* OPTION2: Molecular screening through a national comprehensive tumor profiling program
* OPTION3: Clinically validated targeted sequencing or focused profiling
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Minimum age
12
Months
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Maximum age
39
Years
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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
-Tumors that do not meet HGG and DIPG diagnoses specified above
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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
Not yet recruiting
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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
28/08/2024
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Actual
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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
28/06/2034
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Actual
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Sample size
Target
450
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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Sydney Children's Hospital - Randwick
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Recruitment hospital [2]
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Queensland Children's Hospital - South Brisbane
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Recruitment hospital [3]
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Perth Children's Hospital - Perth
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Recruitment postcode(s) [1]
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2031 - Randwick
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Recruitment postcode(s) [2]
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4101 - South Brisbane
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Recruitment postcode(s) [3]
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6000 - Perth
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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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Colorado
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United States of America
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State/province [2]
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District of Columbia
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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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Illinois
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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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Massachusetts
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Country [5]
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United States of America
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North Carolina
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Country [6]
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Ohio
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Country [7]
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United States of America
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Pennsylvania
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Country [8]
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State/province [8]
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Texas
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Country [9]
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United States of America
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State/province [9]
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Washington
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Country [10]
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Canada
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State/province [10]
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Ontario
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Country [11]
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Canada
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State/province [11]
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Quebec
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Country [12]
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Germany
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State/province [12]
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Baden-Württemberg
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Country [13]
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Netherlands
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State/province [13]
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Utrecht
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Country [14]
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United Kingdom
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State/province [14]
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London
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Funding & Sponsors
Primary sponsor type
Other
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Name
Nationwide Children's Hospital
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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 goal of this study is to perform genetic sequencing on brain tumors from children, adolescents, and young adult patients who have been newly diagnosed with a high-grade glioma. This molecular profiling will decide if patients are eligible to participate in a subsequent treatment-based clinical trial based on the genetic alterations identified in their tumor.
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Trial website
https://clinicaltrials.gov/study/NCT05839379
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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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Maryam Fouladi, MD
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Address
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Nationwide Children's Hospital
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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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Amy K Jones, MSN
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Address
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Country
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Phone
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16147223284
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Fax
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Email
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[email protected]
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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)?
Undecided
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No/undecided IPD sharing reason/comment
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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/NCT05839379