Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer

NCT07226466 | Not Yet Recruiting

• 2 other identifiers: 249213NCI-2025-01532
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (12)

• Mean change in serum Amyloid-beta peptide (Aβ)

  Mean change in biomarker for Aβ over time will be reported

  Up to 12 months

• Mean change in serum Amyloid-beta peptide (Aβ) by APOE genotype

  Mean change in biomarker for Aβ by APOE genotype over time will be reported

  Up to 12 months

• Mean change of score on the European Organization for Research and Treatment of Cancer quality of life questionnaire - Brain Module (EORTC-QLQ-BN20)

  The EORTC QLQ-BN20 consists of 20 questions; seven single item symptom scales (headaches, seizures, drowsiness, hair loss, itchy skin, leg weakness and bladder control), along with four multi-item scales (future uncertainty, visual disorder, motor dysfunction and communication deficit). Raw scores for the QLQ-BN20 items are computed by calculating the mean of the items in each subscale, or the item for each individual and linearly transform the scores to a 0-100 scale. A higher score represents worse QOL for all QLQ-BN20 scales and single items.

  Up to 18 months from date of first radiation dose

• Mean change in serum Glial Fibrillary Acidic Protein (GFAP)

  Mean change in biomarker for GFAP over time will be reported

  Up to 12 months

• Mean change in serum Glial Fibrillary Acidic Protein (GFAP) by APOE genotype

  Mean change in biomarker for GFAP by APOE genotype over time will be reported

  Up to 12 months

• Mean change in serum Phosphorylated TAU (p-TAU)

  Mean change in biomarker for p-TAU over time will be reported

  Up to 12 months

• Mean change in serum Phosphorylated TAU (p-TAU) by APOE genotype

  Mean change in biomarker for p-TAU by APOE genotype over time will be reported

  Up to 12 months

• Mean change in serum Neurofilament Light Chain (NfL)

  Mean change in biomarker for NfL over time will be reported

  Up to 12 months

• Mean change in serum Neurofilament Light Chain (NfL) by APOE genotype

  Mean change in biomarker for NfL by APOE genotype over time will be reported

  Up to 12 months

• Mean change in Brain Health Assessment by APOE genotype

  Mean change in of Brain Health Assessment by APOE genotype over time will be reported

  Up to 12 months

• Mean change in Hippocampal Volume

  Mean change in Hippocampal Volume as measured by MRI over time will be reported

  Up to 12 months

• Mean change in Hippocampal Volume by APOE genotype

  Mean change in Hippocampal Volume as measured by MRI by APOE genotype over time will be reported

  Up to 12 months

Secondary Outcomes (1)

• Change in scores on the European Organization for Research and Treatment of Cancer quality of life questionnaire 30 (EORTC-QLQ-C30) over time

  Up to 18 months from date of first radiation dose

Study Arms (1)

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.

Procedure: Blood sample; Procedure: Brain magnetic resonance imaging (MRI); Procedure: Brain Health Assessment; Radiation: Quality of Life (QoL) Questionnaire

Interventions

Blood sample PROCEDURE

Blood sample will be collected

Adults with Brain Tumor Receiving Radiotherapy

Brain magnetic resonance imaging (MRI) PROCEDURE

Brain MRI will be performed during the course of data collection

Adults with Brain Tumor Receiving Radiotherapy

Brain Health Assessment PROCEDURE

Brain Health Assessment will be performed during the course of data collection

Adults with Brain Tumor Receiving Radiotherapy

Quality of Life (QoL) Questionnaire RADIATION

QoL questionnaire will be given to participants during the course of data collection

Adults with Brain Tumor Receiving Radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with brain cancers receiving care at University of California, San Francisco (UCSF)

You may qualify if:

• \>= 18 years old
• Diagnosis of a primary brain tumor OR #3. Not both #2 and #3.
• Diagnosis of primary solid tumor and secondary involvement of the brain
• If the patient has brain metastases: fewer than 5 brain metastases (post-operative and definitive allowed), none \> 1 cm in max diameter.
• Candidate for standard of care / usual care (SOC) focused brain radiotherapy.
• No prior brain radiotherapy, including whole brain radiotherapy.
• Eastern Cooperative Oncology Group (ECOG) functional score 0 or 1.
• Estimated life expectancy post-treatment of \> 2 years.

You may not qualify if:

• Diagnosis of neurodegenerative disease (Alzheimer's disease, Parkinson's disease).
• Diagnosis of memory disorder pre-treatment.
• Leptomeningeal disease or disease involving either hippocampus.

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be obtained.

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Blood Specimen Collection; Quality of Life; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health; Data Collection; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Jean Nakamura, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean Nakamura, MD

CONTACT

(415) 514-4997; Jean.Nakamura@ucsf.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2025
• First Posted: November 10, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)