Long-term follow-up for medulloblastoma survivors treated with craniospinal irradiation

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 observational protocol uses the St. Jude Lifetime Cohort (SJLIFE) infrastructure to collect a cross-sectional baseline and then follow medulloblastoma survivors treated with contemporary regimens, including photon and proton craniospinal irradiation. Participants undergo a comprehensive set of medical evaluations and patient-reported outcome surveys tailored to detect therapy-related late effects such as neurocognitive changes, hearing loss, cardiopulmonary and endocrine problems, musculoskeletal conditions, and fertility issues. There are two cohorts: CSIMEMPHIS (all eligible survivors) and BRAINatomy2, which requires non-sedated MRI tolerance and no history of clinically significant progressive focal seizures (PFS). Data will inform long-term surveillance recommendations and help identify outcomes for future studies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosis of any subtype of medulloblastoma between the ages of 3 to 22 years or between the ages of 22 to 44 years with the sonic hedgehog (SHH) subtype of medulloblastoma
* Radiotherapy on or according to the SJMB12 protocol
* Received radiotherapy at St. Jude Children's Research Hospital
* 5 or more years since the initiation of radiation therapy and who did not have evidence of disease progression
* Provision of informed consent by participant/guardian or legal representative; Assent by minor participant
* Participants may choose to complete all or a subset of the proposed assessments; refusal to participate in some aspects of the study will not preclude participant inclusion
* Participants must also complete enrollment on SJLIFE

Exclusion Criteria:

* Participants or their legal guardian/representative are unwilling or unable to provide written informed consent.
* Participants who had relapsed or refractory disease during or following completion of treatment for medulloblastoma

Where it's running

• St. Jude Children's Research Hospital
  Memphis, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Thomas E Merchant, DO, PhD — St. Jude Children's Research Hospital
• Study coordinator: Thomas E Merchant, DO, PhD
• Email: referralinfo@stjude.org
• Phone: 888-226-4343

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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.