This study is not yet accepting patients

Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer

a study on Brain Tumor Brain Cancer Solid Tumor Quality of Life

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
study ends around
Principal Investigator
by Jean Nakamura, MD (ucsf)
Headshot of Jean Nakamura
Jean Nakamura

Description

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.

Details

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.

Keywords

Brain Tumor Adult, Brain Metastases From Solid Tumors, Brain Tumor, Primary, Brain Tumor, Brain Neoplasms, Blood Specimen Collection, Quality of Life, Surveys and Questionnaires, Brain magnetic resonance imaging (MRI), Brain Health Assessment

Eligibility

You can join if…

Open to people ages 18 years and up

  1. >= 18 years old
  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.

You CAN'T join if...

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

Location

  • University of California, San Francisco
    San Francisco 5391959 California 5332921 94143 United States

Lead Scientist at University of California Health

  • Jean Nakamura, MD (ucsf)
    Professor, Radiation Oncology, School of Medicine. Authored (or co-authored) 62 research publications

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT07226466
Study Type
Observational
Participants
Expecting 40 study participants
Last Updated