Recruiting NCT07085325

CSIMEMPHIS: Long-term Follow-up of Medulloblastoma Survivors That Received Craniospinal Irradiation

— Observational Medulloblastoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Medulloblastoma. Basic parameters: No limits · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

This is initially a cross-sectional timepoint serving as the baseline for prospective follow-up to evaluate health outcomes in a population of childhood medulloblastoma survivors treated with contemporary therapy, including both photon and proton Craniospinal irradiation (CSI).

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.

Primary outcome measures

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. [Time frame: Baseline]

Secondary outcome measures (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. [Time frame: Baseline]

Eligibility 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
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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model: Cohort

Study locations

United States · 1 center

St. Jude Children's Research Hospital — Memphis

Identifiers

NCT: NCT07085325 · CSIMEMPHIS · NCI-2025-07105

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗