International Rare Brain Tumor Registry (IRBTR)

March 26, 2026 updated by: Adriana Fonseca, Children's National Research Institute
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.

Study Overview

Status

Recruiting

Conditions

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, PLAG/L1, and other rare or 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 Type

Observational

Enrollment (Estimated)

5800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
      • Haifa, Israel, 3525409
      • Petah Tikva, Israel, 4920235
        • Recruiting
        • Schneider Children's Medical Center- CLALIT Health Services
        • Principal Investigator:
          • Helen Toledano, MD
        • Contact:
        • Contact:
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Dana-Dwek Children's Hospital- Tel Aviv Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yair Peled, MD
      • Tel Litwinsky, Israel, 52621
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • Children's Hospital Los Angeles
        • Principal Investigator:
          • Nathan Robison, MD
        • Contact:
        • Contact:
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California San Francisco
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marie Jaeger-Krause, MD
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Ohio
      • Akron, Ohio, United States, 44308
      • Cincinnati, Ohio, United States, 45229-3026
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Scott Raskin, DO

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
CNS Sarcoma
Patients diagnosed with Central nervous system (CNS) sarcomas
BCOR-altered
Patients diagnosed with tumors characterized by alterations in the BCOR gene.
Astroblastoma/MN-1- altered
Patients diagnosed with Astroblastomas/MN-1 alterations
Unclassifiable tumors
Patients diagnosed with histologically ambiguous tumors or tumors that fail to classify with the current diagnostic methods.
Other Rare Brain tumors
Patients diagnosed with other rare brain tumors that do not meet the criteria for cohorts 1-4.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free Survival
Time Frame: 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.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Molecular characterization
Time Frame: 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.
10 years
Radiological characterization
Time Frame: 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).
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's National Research Institute

Investigators

  • Principal Investigator: Adriana Fonseca, MD, afonsecash@childrensnational.org

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 1, 2033

Study Completion (Estimated)

December 1, 2033

Study Registration Dates

First Submitted

January 23, 2023

First Submitted That Met QC Criteria

January 23, 2023

First Posted (Actual)

January 26, 2023

Study Record Updates

Last Update Posted (Actual)

March 31, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00000324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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