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Relapsed and Progressive Sonic Hedgehog Medulloblastoma With U1 Mutation Registry Study

NCT07242963 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-04-13

No results posted yet for this study

Summary

The purpose of this study is to create a biobank for patients diagnosed with Sonic Hedgehog Medulloblastoma at Baylor College of Medicine/Texas Children's Cancer Center. A biobank is a facility that stores and manages biological samples (such as blood, tissue, or DNA) from individuals, along with detailed health information, for use in medical research to study diseases and develop new treatments. The investigators are requesting participants' permission to add their information and samples to this biobank.

Being in this research study is voluntary; it is the participant's choice. If the participant joins this study, they can still stop at any time.

If the participant decides to participate, the investigators will review the participant's clinical medical records, demographics, treatment history, family history, and imaging. The investigators will also collect biological samples from the participant and the biological parents' buccal swabs (optional).

The participation in this biobank will last about 5 years from the decision to participate.

Why am I being asked to participate? The participant or their child is invited to participate in this study if the participant or their tumor may have a U1 mutation. U1 mutation is associated with an error in the gene that splices the tumor DNA, leading to random splicing that may increase the tumor mutation burden and generate novel tumor neoantigens (targets). Studying the U1 mutation will enable the investigator to design more effective therapies and guide future treatments for patients with relapsed or refractory sonic hedgehog medulloblastoma, thereby improving their outcomes and quality of life. Moreover, the investigators aim to determine whether germline mutations inherited from parents may increase the risk of medulloblastoma in their offspring. The participant will receive no direct benefit from their participation in this study. However, participation in this study may help the investigators better understand SHH Medulloblastomas and benefit other patients in the future.

Conditions

  • Medulloblastoma Recurrent
  • Medulloblastoma, Childhood, Recurrent
  • Medulloblastoma, SHH-activated and TP53 Mutant
  • Medulloblastoma, SHH-activated and TP53 Wildtype

Sponsors & Collaborators

  • Baylor College of Medicine

    collaborator OTHER

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Mohammad H. Abu Arja

    lead OTHER

Principal Investigators

  • Murali Chintagumpala, MD · Baylor College of Medicine

  • Michael D Taylor, MD, PhD · Baylor College of Medicine

  • Mohammad H Abu-Arja, MD, MSc · Baylor College of Medicine

Eligibility

Min Age
3 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2035-12-30
Completion
2035-12-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07242963 on ClinicalTrials.gov