Not Yet RecruitingNot Applicable

Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer

United States40 participantsStarted 2026-03-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. \>= 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.

Exclusion criteria

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

What they're measuring

Mean change in serum Amyloid-beta peptide (Aβ)

Timeframe: Up to 12 months

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

Timeframe: 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)

Timeframe: Up to 18 months from date of first radiation dose

Mean change in serum Glial Fibrillary Acidic Protein (GFAP)

Timeframe: Up to 12 months

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

Timeframe: Up to 12 months

Mean change in serum Phosphorylated TAU (p-TAU)

Timeframe: Up to 12 months

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

Timeframe: Up to 12 months

Mean change in serum Neurofilament Light Chain (NfL)

Trial details

NCT IDNCT07226466

SponsorUniversity of California, San Francisco

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-05-31

Contact for this trial

Jean Nakamura, MD

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

View on ClinicalTrials.gov More Brain Tumor Adult trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. \>= 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.

Exclusion criteria

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

What they're measuring

Mean change in serum Amyloid-beta peptide (Aβ)

Timeframe: Up to 12 months

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

Timeframe: 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)

Timeframe: Up to 18 months from date of first radiation dose

Mean change in serum Glial Fibrillary Acidic Protein (GFAP)

Timeframe: Up to 12 months

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

Timeframe: Up to 12 months

Mean change in serum Phosphorylated TAU (p-TAU)

Timeframe: Up to 12 months

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

Timeframe: Up to 12 months

Mean change in serum Neurofilament Light Chain (NfL)