Long-Term Follow-Up of Medulloblastoma Survivors that Received Craniospinal Irradiation
The study is being done to learn more about the long-term health and well-being of patients treated for medulloblastoma with radiation therapy on or according to the SJMB12 study and to decide which evaluations focusing on therapy-related lasting effects (or toxicities) should be considered.
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 * Participant/guardian or legal representative must be able to communicate and read in English or Spanish
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 * Participant/guardian or legal representative are not able to communicate and read in English or Spanish
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07085325.
Locations matching your search criteria
United States
Tennessee
Memphis
PRIMARY OBJECTIVES:
I. 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:
Ia. To analyze regional differences in brain activity using fMRI among medulloblastoma survivors treated with different craniospinal doses, chemotherapy regimens and radiation modalities;
Ib. To investigate the long-term impact of posterior fossa syndrome (defined dichotomously and on a continuum of severity) among medulloblastoma survivors including neurological effects, differences in brain activity (fMRI), cognitive effects, speech/language/swallowing outcomes, motor performance, health-related quality of life, social and adaptive functioning;
Ic. To assess health-related quality of life (HRQOL) among medulloblastoma survivors treated with different craniospinal doses, chemotherapy regimens, and radiation modalities;
Id. To map changes in the working memory structural connectome among medulloblastoma survivors treated with varying craniospinal doses, chemotherapy regimens, and radiation modalities;
Ie. To explore the association of social drivers of health (SDOH) with health outcomes among medulloblastoma survivors treated with different craniospinal doses, chemotherapy regimens, and radiation modalities;
If. To evaluate and compare the neurologic effects, complications, surgical injury, and second neoplasms among medulloblastoma survivors treated with varying craniospinal doses, chemotherapy regimens, and radiation modalities;
Ig. To examine and compare endocrinologic effects and complications, including fertility, among medulloblastoma survivors treated with different craniospinal doses, chemotherapy regimens, and radiation modalities;
Ih. To characterize and compare cognitive effects among medulloblastoma survivors treated with varying craniospinal doses, chemotherapy regimens, and radiation modalities;
Ij. To evaluate and compare physiologic effects and complications (cardiorespiratory, musculoskeletal) among medulloblastoma survivors treated with different craniospinal doses, chemotherapy regimens, and radiation modalities.
OUTLINE: This is an observational study. Patients are assigned to 1 of 2 groups.
COHORT I (CSIMEMPHIS): Patients complete questionnaires, undergo functional magnetic resonance imaging (MRI), dual x-ray absorptiometry (DEXA), neurocognitive testing, scale for the assessment and rating of ataxia (SARA), physical activity and heart rate variability, sleep test, thyroid ultrasound, bone age radiograph, and blood sample collection on study. Patients' medical records are also reviewed.
COHORT II ( BRAINatomy2): Patients complete questionnaires, undergo functional MRI, DEXA, neurocognitive testing, SARA, physical activity and heart rate variability, sleep test, thyroid ultrasound, bone age radiograph, and blood sample collection on study. Patients may undergo an additional functional MRI on study. Patients' medical records are also reviewed.
Trial PhaseNo phase specified
Trial TypeNot provided by clinicaltrials.gov
Lead OrganizationSaint Jude Children's Research Hospital
Principal InvestigatorThomas Edward Merchant
- Primary IDCSIMEMPHIS
- Secondary IDsNCI-2025-07105
- ClinicalTrials.gov IDNCT07085325