MedulloblastomaNCT02747576
Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma
An observational study of Medulloblastoma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Survivors of pediatric medulloblastoma (MB) are at-risk for neurocognitive and social deficits, including specific skills such as facial affect recognition which is the ability to recognize the emotional expressions of another person. Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Medulloblastoma
- How many people
- 137 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2016to 31 Aug 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 12 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Medulloblastoma survivors enrolled in the St Jude Lifetime Cohort parent protocol will be recruited to complete comprehensive social-cognitive and neurocognitive evaluations as well as structural and functional brain imaging. Investigators will also recruit a comparison sample of healthy individuals matched on age, sex and race.
Who may be able to join
- Enrolled on the SJLIFE protocol at St. Jude Children's Research Hospital (SJCRH).
- Completed treatment for medulloblastoma at SJCRH.
- Infratentorial tumor location.
- Treated with craniospinal irradiation.
- ≥ 5 years post diagnosis.
- Between 12 and 30 years of age at time of enrollment.
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- English speaking.
- Enrolled on the SJLIFE protocol as a community control.
- Between 12 and 30 years of age at time of enrollment.
- English speaking.
Who cannot join
- Diagnosis of a genetic disorder/pre-existing neurodevelopmental condition associated with neurocognitive or social impairment (e.g., down syndrome, autism).
- History of head injury associated with neurocognitive impairment.
- Diagnosis of a serious psychiatric condition associated with neurocognitive or social morbidities (e.g. schizophrenia).
- Currently pregnant (due to MRI studies).
- Implanted metal unsafe for MRI or medical device (i.e. pacemaker)
- Requires sedation to complete MRI.
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- Legally blind or unaidable hearing loss.
- Treated for medulloblastoma <3 years of age
- Received re-irradiation to the brain.
- Completed SJLIFE HPP-19 (pilot study) at SJCRH.
- No history of childhood cancer or cancer related therapy.
- First degree relative or direct friend of medulloblastoma participant.
- Diagnosis of a genetic disorder/neurodevelopmental condition associated with neurocognitive or social impairment (e.g., down syndrome, autism).
- History of head injury associated with neurocognitive impairment.
- Diagnosis of a serious psychiatric condition associated with neurocognitive or social morbidities (e.g. schizophrenia).
- Currently pregnant (due to MRI studies).
- Implanted metal unsafe for MRI or medical device (i.e. pacemaker).
- Requires sedation to complete MRI.
- Legally blind or unaidable hearing loss.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
Survivors of pediatric medulloblastoma (MB) are at-risk for neurocognitive and social deficits, including specific skills such as facial affect recognition which is the ability to recognize the emotional expressions of another person. Because the underlying mechanisms of these deficits are poorly understood, the investigators propose to examine social-cognitive skills (i.e. facial affect recognition) and indices of brain integrity, including an established core neural network of face perception in MB survivors and healthy controls. By comparing these outcomes between survivors of MB and healthy controls, investigators seek to identify the areas of the brain that help individuals recognize emotions.
Primary Objective:
Read more
- To evaluate social cognition in adolescent and young adult survivors of pediatric medulloblastoma.
Secondary Objective:
- To examine indices of brain integrity and function and their association with facial affect recognition in survivors of pediatric medulloblastoma.
Read the detailed description
Comprehensive social-cognitive and behavioral data will be collected and structural and functional brain imaging will be completed in an attempt to determine if disruptions to brain integrity and function caused by prior treatment of medulloblastoma directly influence social-cognition and behavior in survivors. These outcomes will be compared between survivors and age-, gender-, and race-matched healthy community controls.
Participants who meet eligibility criteria and consent will undergo neurocognitive (intelligence, attention, memory, processing speed, motor, executive function, and visuospatial) and social cognitive evaluations (affect recognition, prosody, social memory, withdrawal/isolation, loneliness, social anxiety, visuospatial, and executive function). Functional magnetic resonance imaging (fMRI) will be completed during affect identification tasks to assess activation of the core face perception network. Magnetic resonance with diffusion tensor imaging (DTI) will be obtained to quantify water diffusion within white matter tracts to assess white matter integrity and its association with functional outcomes.
- Conditions
- Medulloblastoma
- Keywords
- Childhood Cancer Survivor, Social-cognition, Healthy Volunteers
- 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 |
|---|---|---|
| Medulloblastoma Group | Medulloblastoma survivors, 30 between the ages of 12-20 years and 30 between 21-30 years. | |
| Control Group | Health comparison group frequency matched on age (30 between the ages of 12-20 years and 30 between 21-30 years), gender and race. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on standardized measures of facial affect recognition (NEPSY-II; Advanced Clinical Solutions Social Cognition)
Mean scores on measures of facial affect recognition will be compared between survivors of medulloblastoma and age, sex, and race matched community controls.
Measured: Within two months of participant enrollment
Secondary outcomes (3)
Performance on tests of visual spatial processing and executive functioning using standardized neurocognitive assessment measures
Means scores on measures of visual spatial processing and executive function will be compared between survivors of medulloblastoma and age, sex, and race matched community controls.
Measured: Within two months of participant enrollment
Activation of the core face perception network (lateral fusiform gyrus, inferior occipital gyri, superior temporal sulcus) using fMRI analysis
Patterns of brain activation (i.e. hemodynamic responses) will be compared between survivors of medulloblastoma and age, sex, and race matched community controls.
Measured: Within six months of participant enrollment
White matter integrity between the nodes of the core face perception network (lateral fusiform gyrus, inferior occipital gyri, superior temporal sulcus) using DTI analysis
Indices of white matter integrity (e.g., radial diffusivity, axial diffusivity) will be compared between survivors of medulloblastoma and age, sex, and race matched community controls.
Measured: Within six months of participant enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study start13 Jul 2016
- Primary completion25 Jun 2018
- Study completion31 Aug 2018
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 137 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- St. Baldrick's Foundation
- Responsible party
- Sponsor
- Investigators
- Tara M. Brinkman, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02747576
- Sponsor's protocol ID
- FACES
- Status last verified
- Oct 2021
- First submitted
- 13 Apr 2016
- Last updated
- 15 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition and Brain Integrity in Survivors of Pediatric Medulloblastoma
- ClinicalTrials.gov ID
- NCT02747576
- Acronym / sponsor ID
- FACES
- Conditions
- Medulloblastoma
- Keywords
- Childhood Cancer Survivor, Social-cognition, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 137 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- St. Baldrick's Foundation
- Study start
- 13 Jul 2016 (actual)
- Primary completion
- 25 Jun 2018 (actual)
- Study completion
- 31 Aug 2018 (actual)
- First posted
- 22 Apr 2016 (estimated)
- 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.
Survivors of pediatric medulloblastoma (MB) are at-risk for neurocognitive and social deficits, including specific skills such as facial affect recognition which is the ability to recognize the emotional expressions of another person. Because the underlying mechanisms of these deficits are poorly understood, the investigators propose to examine social-cognitive skills (i.e. facial affect recognition) and indices of brain integrity, including an established core neural network of face perception in MB survivors and healthy controls. By comparing these outcomes between survivors of MB and healthy controls, investigators seek to identify the areas of the brain that help individuals recognize emotions.
Primary Objective:
- To evaluate social cognition in adolescent and young adult survivors of pediatric medulloblastoma.
Secondary Objective:
- To examine indices of brain integrity and function and their association with facial affect recognition in survivors of pediatric medulloblastoma.
Detailed description
Comprehensive social-cognitive and behavioral data will be collected and structural and functional brain imaging will be completed in an attempt to determine if disruptions to brain integrity and function caused by prior treatment of medulloblastoma directly influence social-cognition and behavior in survivors. These outcomes will be compared between survivors and age-, gender-, and race-matched healthy community controls.
Participants who meet eligibility criteria and consent will undergo neurocognitive (intelligence, attention, memory, processing speed, motor, executive function, and visuospatial) and social cognitive evaluations (affect recognition, prosody, social memory, withdrawal/isolation, loneliness, social anxiety, visuospatial, and executive function). Functional magnetic resonance imaging (fMRI) will be completed during affect identification tasks to assess activation of the core face perception network. Magnetic resonance with diffusion tensor imaging (DTI) will be obtained to quantify water diffusion within white matter tracts to assess white matter integrity and its association with functional outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medulloblastoma Group | – | –Medulloblastoma survivors, 30 between the ages of 12-20 years and 30 between 21-30 years. |
| Control Group | – | –Health comparison group frequency matched on age (30 between the ages of 12-20 years and 30 between 21-30 years), gender and race. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Medulloblastoma survivors enrolled in the St Jude Lifetime Cohort parent protocol will be recruited to complete comprehensive social-cognitive and neurocognitive evaluations as well as structural and functional brain imaging. Investigators will also recruit a comparison sample of healthy individuals matched on age, sex and race.
Key inclusion criteria (10 listed)
- Enrolled on the SJLIFE protocol at St. Jude Children's Research Hospital (SJCRH).
- Completed treatment for medulloblastoma at SJCRH.
- Infratentorial tumor location.
- Treated with craniospinal irradiation.
- ≥ 5 years post diagnosis.
Key exclusion criteria (19 listed)
- Diagnosis of a genetic disorder/pre-existing neurodevelopmental condition associated with neurocognitive or social impairment (e.g., down syndrome, autism).
- History of head injury associated with neurocognitive impairment.
- Diagnosis of a serious psychiatric condition associated with neurocognitive or social morbidities (e.g. schizophrenia).
- Currently pregnant (due to MRI studies).
- Implanted metal unsafe for MRI or medical device (i.e. pacemaker)
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
Performance on standardized measures of facial affect recognition (NEPSY-II; Advanced Clinical Solutions Social Cognition)
Time frame: Within two months of participant enrollment
Mean scores on measures of facial affect recognition will be compared between survivors of medulloblastoma and age, sex, and race matched community controls.
3 secondary outcomes
Performance on tests of visual spatial processing and executive functioning using standardized neurocognitive assessment measures
Time frame: Within two months of participant enrollment
Activation of the core face perception network (lateral fusiform gyrus, inferior occipital gyri, superior temporal sulcus) using fMRI analysis
Time frame: Within six months of participant enrollment
White matter integrity between the nodes of the core face perception network (lateral fusiform gyrus, inferior occipital gyri, superior temporal sulcus) using DTI analysis
Time frame: Within six months of participant enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2021.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Tara M. Brinkman, 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 10 inclusion and 19 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: finished, as of the sponsor's last update on 15 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on standardized measures of facial affect recognition (NEPSY-II; Advanced Clinical Solutions Social Cognition) (time frame: Within two months of participant enrollment). 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 15 Oct 2021.