International Rare Brain Tumor Registry

NCT05697874 | Recruiting

• 1 other identifier: STUDY00000324
• Study Type: observational
• Target: 5,800
• Locations: 2 countries
• Sites: 10

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.

Conditions

Astroblastoma; BCOR ITD Sarcoma; CNS Sarcoma; Unclassified Tumor, Malignant

Keywords

Rare Brain Tumor; Pediatric Brain Tumor Registry; Unclassifiable tumor; Pediatric Neuro-Oncology; Rare Disease

Outcome Measures

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.

  10 years

Secondary Outcomes (2)

• Molecular characterization

  10 years

• Radiological characterization

  10 years

Study Arms (5)

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.

Eligibility Criteria

• Age: Up to 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (10)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

University of California San Francisco

San Francisco, California, 94158, United States

RECRUITING

Children's National Hospital

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

RECRUITING

Akron Children's Hospital

Akron, Ohio, 44308, United States

RECRUITING

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3026, United States

RECRUITING

Rambam Health Care Campus

Haifa, 3525409, Israel

RECRUITING

Schneider Children's Medical Center- CLALIT Health Services

Petah Tikva, 4920235, Israel

RECRUITING

Dana-Dwek Children's Hospital- Tel Aviv Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

The Sheba Medical Center

Tel Litwinsky, 52621, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor tissue, blood, urine, cerebrospinal fluid (CSF). Samples are collected only if part of a clinically indicated procedure from enrolled individuals.

MeSH Terms

Conditions

Neoplasms, Neuroepithelial; Neoplasms; Rare Diseases

Condition Hierarchy (Ancestors)

Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Adriana Fonseca, MD

  afonsecash@childrensnational.org

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adriana Fonseca, MD

CONTACT

202-476-8399; afonsecash@childrensnational.org

Hope Lovell

CONTACT

202-476-3898; hlovell@childrensnational.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Oncologist

Study Record Dates

• First Submitted: January 23, 2023
• First Posted: January 26, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 1, 2033
• Study Completion (Estimated): December 1, 2033
• Last Updated: March 31, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6); IL (4)