Registry for relapsed or progressive SHH medulloblastoma with U1 mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational registry collects both retrospective and prospective clinical data and tumor samples from patients diagnosed with relapsed, refractory, or progressive SHH medulloblastoma. Participants provide tumor tissue for U1 mutation testing and may provide blood and optional buccal swabs from biological parents for genetic studies. Clinical charts, treatment history, imaging (uploaded or sent on CD), and demographics will be centralized and linked to the biobank. The registry aims to enable molecular characterization and future translational research by making annotated samples and data available to investigators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

For Groups 1 and 2, subjects are eligible to be included in the study only if all of the following criteria are met:

* Age Patients must be ≥ 3 and ≤ 50 years of age at the time of initial diagnosis.
* Diagnosis Participants must have a diagnosis of SHH medulloblastoma by histologic or molecular criteria at the time of original diagnosis or relapse.
* Disease status The disease must be recurrent, refractory, or progressive following therapy, including radiotherapy and chemotherapy.
* Available tumor tissue sample for U1 testing Participants must have available tumor tissue samples to be tested for the U1 mutation.

For Group 3, biological parent(s) of a subject participating in Group 1 or 2 are eligible.

Exclusion Criteria:

Subjects not meeting the inclusion criteria will be excluded.

Where it's running

• Baylor College of Medicine
  Houston, Texas, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Mohammad H Abu-Arja, MD, MSc — Baylor College of Medicine
• Study coordinator: Mohammad H Abu-Arja, MD, MSc
• Email: mohammad.abuarja@bcm.edu
• Phone: 832-824-0592

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.