CSIMEMPHIS: Long-term Follow-up of Medulloblastoma Survivors That Received Craniospinal Irradiation
NCT ID: NCT07085325
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
184 participants
OBSERVATIONAL
2025-12-31
2031-10-31
Brief Summary
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Medulloblastoma outcomes have improved with contemporary therapies including modern neurosurgical techniques and risk-adapted radiotherapy and chemotherapy regimens. However, survivors remain at risk for long-term health problems such as neurocognitive deficits, hearing loss, impaired cardiorespiratory fitness and physical performance, cardiac and neuroendocrine dysfunction, musculoskeletal conditions, and infertility.
Detailed Description
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Participants will be invited to enroll on both SJLIFE and this protocol. This study will utilize the St. Jude Lifetime Cohort (SJLIFE) infrastructure to comprehensively evaluate 5-year survivors of childhood medulloblastoma treated with radiation therapy on or according to SJMB12, including those treated with differing doses and modalities of CSI. Insights gained on late effects will inform long-term surveillance and may identify novel outcomes, guiding future studies. Participants and their parents/guardians will also be asked to complete surveys that assess patient-reported outcomes.
There will be two cohorts of participants - CSIMEMPHIS (all participants who meet initial eligibility criteria) and BRAINatomy2. To be eligible for the Brainatomy2 cohort, survivors must be able to tolerate non-sedated MRI and must not have a history of clinically significant PFS. Recruitment of these patients will be led by staff in Radiation Oncology.
All study participants undergo the SJLIFE comprehensive set of medical evaluations that target overall health and function as well as possible treatment-related toxicities. CSIMEMPHIS participants will undergo testing tailored to medulloblastoma treatment and follow-up. All participants will undergo fMRI at the CSIMEMPHIS visit. For those eligible for BRAINatomy2, the BRAINatomy2 investigational fMRI will be prioritized and all others will undergo the CSIMEMPHIS investigational fMRI.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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CSIMEMPHIS-only Group
Participants meeting the CSIMEMPHIS eligibility criteria.
No interventions assigned to this group
BRAINatomy2 Group
In addition to meeting the eligibility criteria for CSIMEMPHIS, the Brainatomy2 cohort participants must be able to tolerate non-sedated MRI and must not have a history of clinically significant PFS.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 who had relapsed or refractory disease during or following completion of treatment for medulloblastoma
ALL
No
Sponsors
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St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Thomas E Merchant, DO, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Thomas E. Merchant, DO, PhD
Role: primary
Related Links
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St. Jude Children's Research Hospital
Clinical Trials Open at St. Jude
Other Identifiers
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NCI-2025-07105
Identifier Type: OTHER
Identifier Source: secondary_id
CSIMEMPHIS
Identifier Type: -
Identifier Source: org_study_id