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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A and Over
Gender	All

More 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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT07085325
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	St. Jude Children's Research Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Thomas E Merchant, DO, PhD
Principal Investigator Affiliation	St. Jude Children's Research Hospital
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Medulloblastoma
Study Website:	View Trial Website

Additional Details

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.

Arms & Interventions

Arms

: 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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

St. Jude Children's Research Hospital, Memphis 4641239, Tennessee 4662168

Status

Address

St. Jude Children's Research Hospital

Memphis 4641239, Tennessee 4662168, 38105

Site Contact

Thomas E. Merchant, DO, PhD

[email protected]

866-278-5833

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