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

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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

Locations
United States
Tennessee
St. Jude Children's Research Hospital
RECRUITING
Memphis
Contact Information
Primary
Thomas E Merchant, DO, PhD
referralinfo@stjude.org
866-278-5833
Time Frame
Start Date: 2025-12
Estimated Completion Date: 2031-10
Participants
Target number of participants: 184
Treatments
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.
Sponsors
Leads: St. Jude Children's Research Hospital

This content was sourced from clinicaltrials.gov