NCT07226466

Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study investigates the effects of brain radiotherapy on cognitive function by evaluating plasma biomarkers and apolipoprotein E (APOE) genotype in patients with primary or metastatic brain tumors. Standard brain radiotherapy is known to impact cognitive outcomes, yet the underlying biological mechanisms remain unclear.

Detailed description

PRIMARY OBJECTIVES: 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

• Brain Tumor Adult
• Brain Metastases From Solid Tumors
• Brain Tumor, Primary
• Brain Tumor

Interventions

Type	Name	Description
PROCEDURE	Blood sample	Blood sample will be collected
PROCEDURE	Brain magnetic resonance imaging (MRI)	Brain MRI will be performed during the course of data collection
PROCEDURE	Brain Health Assessment	Brain Health Assessment will be performed during the course of data collection
RADIATION	Quality of Life (QoL) Questionnaire	QoL questionnaire will be given to participants during the course of data collection

Timeline

• Start date: 2026-03-01
• Primary completion: 2028-05-31
• Completion: 2028-05-31
• First posted: 2025-11-10
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States