Recruiting

Long-term Effects

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07085325

Conditions

Medulloblastoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Medulloblastoma

Study ID

NCT07085325

Start date

Apr 20, 2026

Status verified date

Jul, 2026

Completion date

Oct, 2031

Anticipated

Primary completion date

Oct, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

184 participants

Anticipated

Interventions and Outcome Measures

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.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Thomas E Merchant, DO, PhD

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Thomas E. Merchant, DO, PhD

888-226-4343referralinfo@stjude.org

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Keywords

  • Medulloblastoma
  • Survivor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-07-06.