International Rare Brain Tumor Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 45
SponsorChildren's National Research Institute
About this trial
The objective of the International Rare Brain Tumor Registry (IRBTR) is to better understand rare brain tumors through the collection of biospecimens and matched clinical data of children, adolescents, and young adult patients diagnosed with rare brain tumors.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a known or suspected CNS Sarcoma.
Patients with a known or suspected BCOR-altered brain tumor
Patients with a known or suspected Astroblastoma/NM-1 altered brain tumor
Patients with known or suspected histologically ambiguous/unclassifiable brain tumor
Disqualifiers
The patient has an extra-CNS primary tumor.
The patient is older than 46 years of age at diagnosis.
The patient or family is not willing to participate or does not sign informed consent.
Trial population
The study population will include patients who have completed the informed consent process and are \<= to 45 years of age at diagnosis of the following: CNS Sarcoma, BCOR-altered tumor, Astroblastoma/MNI-1 altered tumors, histologically ambiguous/unclassifiable brain tumor, rare brain tumor. Patients from anywhere in the world are eligible for enrollment.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
5,800 Participants
are grouped into 5 trial groupsGroup A: CNS Sarcoma
Group B: BCOR-altered
Group C: Astroblastoma/MN-1- altered
Group D: Unclassifiable tumors
Group E: Other Rare Brain tumors
Trial outcomes
Primary outcomes
1
Event-free Survival
The primary outcome measure will be time from diagnosis to an event, defined as the occurrence of progression or recurrence of the disease, occurrence of a second malignant neoplasm, or death from any cause. Each cohort will be analyzed separately.
Time frame
10 yearsSecondary outcomes
1
Molecular characterization
To determine molecular characteristics of each cohort using somatic and germline SNV calling, methylation profiling, fusion calling and gene expression profiling. Molecular findings will be correlated with clinical characteristics to identify risk factors and subgroup-specific therapeutic susceptibilities.
Time frame
10 years2
Radiological characterization
To analyze conventional and advanced imaging findings (including diffusion weighted imaging) of each cohort and correlate them with clinical, histopathology and molecular data (radiogenomics).
Time frame
10 yearsSponsors and contacts
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Source ClinicalTrials.gov