International Rare Brain Tumor Registry

Recruiting

• Conditions: CNS Sarcoma; Unclassified Tumor, Malignant; Astroblastoma; BCOR ITD Sarcoma

• Registration Number: NCT05697874
• Lead Sponsor: Children's National Research Institute

Brief Summary

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.

Detailed Description

The International Rare Brain Tumor Registry (IRBTR) is a prospective observational study that will collect tumor samples and matched clinical and radiological data to better understand the outcomes of patients with rare brain tumors in particular: CNS sarcoma, BCOR, MN-1 altered tumors, and other unclassified rare brain tumors.

Data collected include demographics, disease characteristics, treatment information, radiological imaging, and biospecimen collection if available ( tumor tissues Patients will be followed longitudinally to obtain outcome data. Data collection will continue for approximately 10 years.

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-01-23
• Study First Posted: 2023-01-26
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-12
• Last Update Posted: 2024-02-13
• Primary Completion: 2033-12
• Study Completion: 2033-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5800

Inclusion Criteria

• 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
• Patients with a known or suspected rare brain tumor.
• Signed informed consent by patient/ parent or guardian (assent where applicable) to participate in the study.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Event-free Survival	10 years	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.

Secondary Outcome Measures

Name	Time	Method
Radiological characterization	10 years	To analyze conventional and advanced imaging findings (including diffusion weighted imaging) of each cohort and correlate them with clinical, histopathology and molecular data (radiogenomics).
Molecular characterization	10 years	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.

Trial Locations

Locations (1)

Children's National Hospital; 🇺🇸 Washington, District of Columbia, United States