MedulloblastomaNCT07085325
CSIMEMPHIS: Long-term Follow-up of Medulloblastoma Survivors That Received Craniospinal Irradiation
An observational study of Medulloblastoma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Medulloblastoma
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to Oct 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All participants who meet eligibility criteria and consent to enrollment on the study.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Thomas E. Merchant, DO, PhD, 888-226-4343, referralinfo@stjude.org
About this study
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.
Read the detailed description
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.
- Conditions
- Medulloblastoma
- Keywords
- Medulloblastoma, Survivor
- Medical subject headings
- Medulloblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
In the SJLIFE study Survivors will undergo the SJLIFE core battery of testing with a focus on outcomes for which early evidence has demonstrated the potential association between proton therapy and reduced late-effect burden. Testing includes neuromuscular function, laboratory testing, neurocognitive assessments, physiologic assessments, and outcome questionnaires.
Measured: Baseline
Secondary outcomes (1)
To correlate the spatial distribution of radiation dose with neurologic, endocrine, cognitive, and physiologic outcomes among a subset of medulloblastoma survivors, using both conventional and voxel-based analysis.
Subjects selected for the Brainatomy2 study will undergo a one-time investigational MRI/fMRI study designed to target working memory and processing speed. The investigational MRI/fMRI exam includes Axial T2 weighted imaging for post-surgical and post-radiotherapy assessment of brain parenchymal changes, and 3D isometric voxel T1 volume imaging for structural analysis of the whole brain. It also employs pulsed ASL technique for voxel-based cerebral blood flow assessment and diffusion imaging to generate ADC and FA maps, normalizing anatomical connectivity maps to the T1 volume. Additionally, resting-state functional MRI (fMRI) provides whole brain coverage for analyzing temporal co-activation in BOLD fMRI maps in relation to cognitive testing results.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2025
- Study start20 Apr 2026
- Primary completionOct 2030 (estimated)
- Study completionOct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MedulloblastomaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas E Merchant, DO, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07085325
- Sponsor's protocol ID
- CSIMEMPHIS
- Other IDs
- NCI-2025-07105
- Status last verified
- Jul 2026
- First submitted
- 2 Jul 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSIMEMPHIS: Long-term Follow-up of Medulloblastoma Survivors That Received Craniospinal Irradiation
- ClinicalTrials.gov ID
- NCT07085325
- Acronym / sponsor ID
- CSIMEMPHIS
- Conditions
- Medulloblastoma
- Keywords
- Medulloblastoma, Survivor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2031 (estimated)
- First posted
- 25 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All participants who meet eligibility criteria and consent to enrollment on the study.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
In the SJLIFE study Survivors will undergo the SJLIFE core battery of testing with a focus on outcomes for which early evidence has demonstrated the potential association between proton therapy and reduced late-effect burden. Testing includes neuromuscular function, laboratory testing, neurocognitive assessments, physiologic assessments, and outcome questionnaires.
1 secondary outcome
To correlate the spatial distribution of radiation dose with neurologic, endocrine, cognitive, and physiologic outcomes among a subset of medulloblastoma survivors, using both conventional and voxel-based analysis.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the CTG website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas E Merchant, DO, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medulloblastoma, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas E Merchant, DO, PhD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.