Long-term follow-up for medulloblastoma survivors treated with craniospinal irradiation
CSIMEMPHIS: Long-term Follow-up of Medulloblastoma Survivors That Received Craniospinal Irradiation
This project will see if people treated for medulloblastoma with craniospinal irradiation have lasting health effects years after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 184 (estimated) |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT07085325 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal participants are medulloblastoma survivors treated with SJMB12-style craniospinal irradiation (photon or proton) who are at least five years past the start of radiation and meet the protocol's age and consent requirements.
Not a fit: Patients who relapsed or had refractory disease during or after treatment, those less than five years from radiation initiation, or those treated outside the defined regimens may not gain useful information from this protocol.
Why it matters
Potential benefit: If successful, the findings could lead to improved long-term surveillance and management plans that reduce or mitigate late treatment effects in medulloblastoma survivors.
How similar studies have performed: Similar long-term survivorship cohorts, including prior SJLIFE analyses, have previously documented many late effects of childhood cancer treatment, so this approach builds on established methods rather than testing a novel therapy.
Eligibility criteria
Show full inclusion / exclusion criteria
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 * 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 this trial is running
Memphis, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.