Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer
NCT ID: NCT07226466
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
40 participants
OBSERVATIONAL
2026-03-01
2028-05-31
Brief Summary
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Detailed Description
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1. Assess plasma biomarkers for Aβ, GFAP, phospho Tau, and NfL pre- and post-radiotherapy.
2. Determine APOE genotype.
3. Evaluate neuropsychiatric testing aligned with standard of care brain MRIs and serum markers.
4. Measure brain morphometrics pre- and post-radiotherapy with standard of care brain MRIs.
SECONDARY OBJECTIVES:
1\. Measure patient-reported quality of life changes pre- and post-radiotherapy using a standard University of California, San Francisco (UCSF) -approved questionnaire.
OUTLINE:
This is a single-arm, non-randomized, open-label pilot study. Participants will be study duration spans 12 months post-brain radiotherapy.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Adults with Brain Tumor Receiving Radiotherapy
The study entails longitudinal assessment of plasma biomarkers (Aβ, GFAP, phospho Tau, NfL), determination of APOE genotype, neuropsychiatric testing Brain Health Assessment test (BHA), a clinically validated neurocognitive battery compiling metrics on memory and language), and brain morphometric measurements synchronized with standard of care brain MRIs.
Blood sample
Blood sample will be collected
Brain magnetic resonance imaging (MRI)
Brain MRI will be performed during the course of data collection
Brain Health Assessment
Brain Health Assessment will be performed during the course of data collection
Quality of Life (QoL) Questionnaire
QoL questionnaire will be given to participants during the course of data collection
Interventions
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Blood sample
Blood sample will be collected
Brain magnetic resonance imaging (MRI)
Brain MRI will be performed during the course of data collection
Brain Health Assessment
Brain Health Assessment will be performed during the course of data collection
Quality of Life (QoL) Questionnaire
QoL questionnaire will be given to participants during the course of data collection
Eligibility Criteria
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Inclusion Criteria
2. Diagnosis of a primary brain tumor OR #3. Not both #2 and #3.
3. Diagnosis of primary solid tumor and secondary involvement of the brain
4. If the patient has brain metastases: fewer than 5 brain metastases (post-operative and definitive allowed), none \> 1 cm in max diameter.
5. Candidate for standard of care / usual care (SOC) focused brain radiotherapy.
6. No prior brain radiotherapy, including whole brain radiotherapy.
7. Eastern Cooperative Oncology Group (ECOG) functional score 0 or 1.
8. Estimated life expectancy post-treatment of \> 2 years.
Exclusion Criteria
2. Diagnosis of memory disorder pre-treatment.
3. Leptomeningeal disease or disease involving either hippocampus.
18 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Jean Nakamura, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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University of California, San Francisco
San Francisco, California, United States
Countries
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Central Contacts
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Facility Contacts
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Jean Nakamura, MD
Role: primary
Other Identifiers
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NCI-2025-01532
Identifier Type: REGISTRY
Identifier Source: secondary_id
249213
Identifier Type: -
Identifier Source: org_study_id