Actively Recruiting

All Genders
ID07085325

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

Led by St. Jude Children's Research Hospital · Updated on 2026-04-24

184

Participants Needed

1

Research Sites

52 weeks

Total Duration

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AI-Summary

What this Trial Is About

Researchers are evaluating the long-term health and well-being of people who survived medulloblastoma after receiving treatment with modern therapies, including neurosurgery, radiotherapy, and chemotherapy. The study focuses on lasting effects of therapy such as neurocognitive deficits, hearing loss, reduced physical fitness, heart and endocrine problems, musculoskeletal issues, and infertility. It aims to identify important long-term toxicities and improve future care for survivors treated on or according to the SJMB12 protocol. Participants include childhood medulloblastoma survivors treated with radiation therapy, including both photon and proton craniospinal irradiation (CSI). There are two groups: the CSIMEMPHIS group, which includes all eligible survivors, and the BRAINatomy2 group, which additionally requires participants to tolerate non-sedated MRI and not have a history of significant posterior fossa syndrome (PFS). Both groups undergo comprehensive medical evaluations, tailored testing for medulloblastoma treatment effects, and functional MRI (fMRI) scans. During the study, participants will complete detailed health assessments covering overall function and treatment-related toxicities, including surveys for patient-reported outcomes. The study will compare long-term health outcomes based on radiation dose, chemotherapy regimens, and radiation types. Data from fMRI and other tests will be used to analyze neurological, endocrine, cognitive, and physiological effects. The study contributes to understanding late effects and guiding long-term surveillance for survivors. Participation involves initial cross-sectional evaluation and prospective follow-up, lasting multiple years.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of any subtype of medulloblastoma between ages 3 to 22 years
  • Diagnosis of sonic hedgehog (SHH) subtype medulloblastoma between ages 22 to 44 years
  • Treated with radiotherapy on or according to the SJMB12 protocol
  • At least 5 years since starting radiation therapy without evidence of disease progression
  • Provided informed consent or assent by minor participant
  • Completed enrollment on the St. Jude Lifetime Cohort (SJLIFE)
  • Participants may complete all or some study assessments
Not Eligible

You will not qualify if you...

  • Unwilling or unable to provide written informed consent
  • Had relapsed or refractory medulloblastoma during or after treatment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Baseline timepoint at enrollment

Participants undergo comprehensive medical evaluations tailored to medulloblastoma treatment and follow-up, including an investigational fMRI and patient-reported outcome surveys.

1 baseline visit (in-person)

Long-term Monitoring

Duration - Ongoing follow-up up to several years

Participants are followed prospectively to evaluate long-term health outcomes and late effects after craniospinal irradiation treatment for medulloblastoma.

Additional assessments may occur depending on cohort assignment

Trial Site Locations

Total: 1 location

1

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

Actively Recruiting

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Research Team

T

Thomas E Merchant, DO, PhD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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