Posterior Fossa TumorsNCT07350382
Predicting Cognitive Dysfunction After Pediatric Posterior Fossa Tumor Surgery
An observational study of Posterior Fossa Tumors and Pediatric Tumor of Brain, run by West China Hospital at 1 site in China.
Trial summary
The goal of this observational study is to develop and validate a clinical prediction model to identify risk factors for long-term cognitive dysfunction in children (ages 0-18 years) who have undergone surgical resection of a posterior fossa tumor. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Posterior Fossa Tumors, Pediatric Tumor of Brain
- What is being tested?
- Not applicable- observational study
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 1 Jan 2024
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: This study includes 600 children aged 0-18 years who underwent surgical resection of a primary posterior fossa tumor (e.g., medulloblastoma, ependymoma, or pilocytic astrocytoma). All participants had preoperative brain MRI with diffusion tensor imaging (DTI), received standard-of-care treatment, and completed comprehensive neuropsychological assessments at approximately 1 year post-surgery. The cohort represents a real-world pediatric neuro-oncology population treated at multiple tertiary care centers.
Who may be able to join
- Age 0-18 years at time of surgery
- Histopathologically confirmed primary posterior fossa tumor (e.g., medulloblastoma, ependymoma, pilocytic astrocytoma)
- Underwent surgical resection of the tumor at the hospital
- Availability of preoperative brain MRI and diffusion tensor imaging (DTI)
- Completed standardized neuropsychological assessment at approximately 1 year post-surgery
Who cannot join
- Pre-existing neurological or neurodevelopmental disorders (e.g., autism, intellectual disability, cerebral palsy)
- History of prior cranial irradiation or chemotherapy before posterior fossa surgery
- Incomplete clinical, imaging, or follow-up data required for model variables
- Tumor recurrence or progression before 1-year cognitive assessment
- Non-posterior fossa primary brain tumors (e.g., supratentorial gliomas)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Internal Validation of a Machine Learning-Enhanced Nomogram to Stratify Risk of Chronic Cognitive Impairment Following Pediatric Posterior Fossa Surgery
The goal of this observational study is to develop and validate a clinical prediction model to identify risk factors for long-term cognitive dysfunction in children (ages 0-18 years) who have undergone surgical resection of a posterior fossa tumor. The main questions it aims to answer are:
Can a combination of preoperative and postoperative clinical, surgical, and neuroimaging factors accurately predict which children will develop long-term cognitive dysfunction after posterior fossa tumor surgery? Is white matter integrity-specifically fractional anisotropy (FA) of the superior cerebellar peduncle (SCP)-a key independent predictor of cognitive outcomes? Researchers will compare children who developed long-term cognitive dysfunction (cases) to those who did not (controls) to see if differences in imaging biomarkers (e.g., SCP FA, fMRI abnormalities), tumor characteristics (e.g., location, volume, histology), treatment factors (e.g., radiotherapy, surgical approach), and demographic variables (e.g., age) are associated with cognitive outcomes.
Read more
Participants were not asked to perform any tasks or receive any interventions as part of this study, because it is a retrospective analysis of existing medical records and imaging data. Data collected included:
Preoperative and postoperative brain MRI and DTI scans Tumor pathology and surgical reports Treatment details (e.g., radiation, chemotherapy) Neuropsychological assessment results at 1-year follow-up
- Conditions
- Posterior Fossa Tumors, Pediatric Tumor of Brain
- Being tested
- Not applicable- observational study
- Keywords
- Pediatric posterior fossa tumor, Cognitive dysfunction, Cerebellar cognitive affective syndrome, Predictive model, Machine learning, Nomogram, Calibration curve
- Medical subject headings
- Infratentorial Neoplasms, Cognitive Dysfunction, Cerebellar Cognitive Affective Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Not applicable- observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| pediatric patients who underwent surgical resection of a posterior fossa tumor | Stratify this cohort into two subgroups based on outcome:
Those with long-term cognitive dysfunction (n=172) Those without (n=428) Receives: Other: Not applicable- observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Long-Term Cognitive Dysfunction
Presence or absence of long-term cognitive dysfunction, defined as a full-scale IQ (FSIQ) score < 85 or significant impairment in ≥2 cognitive domains (e.g., attention, memory, executive function, processing speed) on standardized neuropsychological assessment at 1-year follow-up.
Measured: 1 year
Secondary outcomes (2)
Model Discrimination Performance
Area Value under the receiver operating characteristic curve (AUC) of the final predictive model (nomogram) in the internal validation cohort.
Measured: 1 year post-surgery
Model Calibration Accuracy
Agreement degree between predicted probability and observed frequency of cognitive dysfunction, assessed by Hosmer-Lemeshow test P Value.
Measured: 1 year after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2015
- Primary completion30 Dec 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posterior Fossa TumorsStudies of the same condition, open and under way.
- More trials run by West China 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 only
- Time perspective
- Retrospective
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Lan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07350382
- Sponsor's protocol ID
- WestChinaH-HX-2025-012
- Status last verified
- Jan 2024
- First submitted
- 5 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Internal Validation of a Machine Learning-Enhanced Nomogram to Stratify Risk of Chronic Cognitive Impairment Following Pediatric Posterior Fossa Surgery
- ClinicalTrials.gov ID
- NCT07350382
- Acronym / sponsor ID
- WestChinaH-HX-2025-012
- Conditions
- Posterior Fossa Tumors, Pediatric Tumor of Brain
- Keywords
- Pediatric posterior fossa tumor, Cognitive dysfunction, Cerebellar cognitive affective syndrome, Predictive model, Machine learning, Nomogram, Calibration curve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 20 Jan 2026 (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 goal of this observational study is to develop and validate a clinical prediction model to identify risk factors for long-term cognitive dysfunction in children (ages 0-18 years) who have undergone surgical resection of a posterior fossa tumor. The main questions it aims to answer are:
Can a combination of preoperative and postoperative clinical, surgical, and neuroimaging factors accurately predict which children will develop long-term cognitive dysfunction after posterior fossa tumor surgery? Is white matter integrity-specifically fractional anisotropy (FA) of the superior cerebellar peduncle (SCP)-a key independent predictor of cognitive outcomes? Researchers will compare children who developed long-term cognitive dysfunction (cases) to those who did not (controls) to see if differences in imaging biomarkers (e.g., SCP FA, fMRI abnormalities), tumor characteristics (e.g., location, volume, histology), treatment factors (e.g., radiotherapy, surgical approach), and demographic variables (e.g., age) are associated with cognitive outcomes.
Participants were not asked to perform any tasks or receive any interventions as part of this study, because it is a retrospective analysis of existing medical records and imaging data. Data collected included:
Preoperative and postoperative brain MRI and DTI scans Tumor pathology and surgical reports Treatment details (e.g., radiation, chemotherapy) Neuropsychological assessment results at 1-year follow-up
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pediatric patients who underwent surgical resection of a posterior fossa tumor | – | Other: Not applicable- observational studyStratify this cohort into two subgroups based on outcome: Those with long-term cognitive dysfunction (n=172) Those without (n=428) |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study includes 600 children aged 0-18 years who underwent surgical resection of a primary posterior fossa tumor (e.g., medulloblastoma, ependymoma, or pilocytic astrocytoma). All participants had preoperative brain MRI with diffusion tensor imaging (DTI), received standard-of-care treatment, and completed comprehensive neuropsychological assessments at approximately 1 year post-surgery. The cohort represents a real-world pediatric neuro-oncology population treated at multiple tertiary care centers.
Key inclusion criteria (5 listed)
- Age 0-18 years at time of surgery
- Histopathologically confirmed primary posterior fossa tumor (e.g., medulloblastoma, ependymoma, pilocytic astrocytoma)
- Underwent surgical resection of the tumor at the hospital
- Availability of preoperative brain MRI and diffusion tensor imaging (DTI)
- Completed standardized neuropsychological assessment at approximately 1 year post-surgery
Key exclusion criteria (5 listed)
- Pre-existing neurological or neurodevelopmental disorders (e.g., autism, intellectual disability, cerebral palsy)
- History of prior cranial irradiation or chemotherapy before posterior fossa surgery
- Incomplete clinical, imaging, or follow-up data required for model variables
- Tumor recurrence or progression before 1-year cognitive assessment
- Non-posterior fossa primary brain tumors (e.g., supratentorial gliomas)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Not applicable- observational study | Other | pediatric patients who underwent surgical resection of a posterior fossa tumor |
Primary outcome
Incidence of Long-Term Cognitive Dysfunction
Time frame: 1 year
Presence or absence of long-term cognitive dysfunction, defined as a full-scale IQ (FSIQ) score < 85 or significant impairment in ≥2 cognitive domains (e.g., attention, memory, executive function, processing speed) on standardized neuropsychological assessment at 1-year follow-up.
2 secondary outcomes
Model Discrimination Performance
Time frame: 1 year post-surgery
Model Calibration Accuracy
Time frame: 1 year after surgery
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 20 Jan 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Posterior Fossa Tumors and Pediatric Tumor of Brain, run by West China Hospital at 1 site in China.
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 5 inclusion and 5 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 20 Jan 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 China. 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?
Incidence of Long-Term Cognitive Dysfunction (time frame: 1 year). 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 20 Jan 2026.