CSIMEMPHIS: Long-term Follow-up of Medulloblastoma Survivors That Received Craniospinal Irradiation
2 other identifiers
observational
184
1 country
1
Brief Summary
The study is being done to learn more about the long-term health and well-being of participants treated for medulloblastoma. The study is to decide which evaluations focusing on therapy-related lasting effects (or toxicities) should be considered. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 2, 2025
CompletedFirst Posted
Study publicly available on registry
July 25, 2025
CompletedStudy Start
First participant enrolled
April 20, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2031
April 24, 2026
April 1, 2026
4.5 years
July 2, 2025
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To describe and compare the long-term health outcomes among medulloblastoma survivors treated with radiation therapy on or according to the SJMB12 protocol with varying craniospinal doses, chemotherapy regimens, and radiation modalities.
In the SJLIFE study Survivors will undergo the SJLIFE core battery of testing with a focus on outcomes for which early evidence has demonstrated the potential association between proton therapy and reduced late-effect burden. Testing includes neuromuscular function, laboratory testing, neurocognitive assessments, physiologic assessments, and outcome questionnaires.
Baseline
Secondary Outcomes (1)
To correlate the spatial distribution of radiation dose with neurologic, endocrine, cognitive, and physiologic outcomes among a subset of medulloblastoma survivors, using both conventional and voxel-based analysis.
Baseline
Other Outcomes (12)
Analyze regional differences in brain activity using fMRI among medulloblastoma survivors treated with different craniospinal doses, chemotherapy regimens and radiation modalities.
Baseline
To investigate the long-term impact of posterior fossa syndrome among medulloblastoma survivors including neurological brain activity with cognitive function.
Baseline
To investigate the long-term impact of posterior fossa syndrome among medulloblastoma survivors including speech and language.
Baseline
- +9 more other outcomes
Study Arms (2)
CSIMEMPHIS-only Group
Participants meeting the CSIMEMPHIS eligibility criteria.
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.
Eligibility Criteria
All participants who meet eligibility criteria and consent to enrollment on the study.
You may qualify if:
- 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
- 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 must also complete enrollment on SJLIFE
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
Biospecimen
Genetic Testing - Germline genetic studies (whole genome and exome) will be performed and banked specifically for future use by CSIMEMPHIS investigators. Gut Microbiome - Stool self-collection will occur around the time of study visits, with samples stored at room temperature in tubes within ziplock bags for up to 24 hours.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Thomas E Merchant, DO, PhD
St. Jude Children's Research Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2025
First Posted
July 25, 2025
Study Start
April 20, 2026
Primary Completion (Estimated)
October 1, 2030
Study Completion (Estimated)
October 1, 2031
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available at the time of article publication.
- Access Criteria
- Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.
Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.