Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05839379




Registration number
NCT05839379
Ethics application status
Date submitted
20/04/2023
Date registered
3/05/2023
Date last updated
14/05/2024

Titles & IDs
Public title
Targeted Pediatric High-Grade Glioma Therapy
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
Secondary ID [1] 0 0
TarGeT-SCR
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
High Grade Glioma 0 0
Diffuse Intrinsic Pontine Glioma 0 0
Anaplastic Astrocytoma 0 0
Glioblastoma 0 0
Glioblastoma Multiforme 0 0
Diffuse Midline Glioma, H3 K27M-Mutant 0 0
Metastatic Brain Tumor 0 0
WHO Grade III Glioma 0 0
WHO Grade IV Glioma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Brain
Cancer 0 0 0 0
Children's - Brain

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Molecular profiling
Timepoint [1] 0 0
4 years
Primary outcome [2] 0 0
Feasibility of molecular profiling and enrollment to a TarGeT treatment protocol
Timepoint [2] 0 0
4 years
Secondary outcome [1] 0 0
Genomic Research
Timepoint [1] 0 0
6 years
Secondary outcome [2] 0 0
Germline susceptibility testing
Timepoint [2] 0 0
4 years
Secondary outcome [3] 0 0
Biobanking
Timepoint [3] 0 0
4 years

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
Minimum age
12 Months
Maximum age
39 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Tumors that do not meet HGG and DIPG diagnoses specified above

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
30/05/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/05/2034
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
Recruitment hospital [1] 0 0
Sydney Children's Hospital - Randwick
Recruitment hospital [2] 0 0
Queensland Children's Hospital - South Brisbane
Recruitment hospital [3] 0 0
Perth Children's Hospital - Perth
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
4101 - South Brisbane
Recruitment postcode(s) [3] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Colorado
Country [2] 0 0
United States of America
State/province [2] 0 0
District of Columbia
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Ohio
Country [7] 0 0
United States of America
State/province [7] 0 0
Pennsylvania
Country [8] 0 0
United States of America
State/province [8] 0 0
Texas
Country [9] 0 0
United States of America
State/province [9] 0 0
Washington
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Germany
State/province [12] 0 0
Baden-Württemberg
Country [13] 0 0
Netherlands
State/province [13] 0 0
Utrecht
Country [14] 0 0
United Kingdom
State/province [14] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Nationwide Children's Hospital
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05839379
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Maryam Fouladi, MD
Address 0 0
Nationwide Children's Hospital
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Leonie Mikael, PhD
Address 0 0
Country 0 0
Phone 0 0
16147223284
Fax 0 0
Email 0 0
leonie.mikael@nationwidechildrens.org
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05839379