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Not yet recruiting NCT07226466

Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer

— Observational Brain Tumor Adult Brain Metastases From Solid Tumors Brain Tumor, Primary Brain Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blood sample, Brain magnetic resonance imaging (MRI), Brain Health Assessment, Quality of Life (QoL) Questionnaire.
Who it may be relevant to
Registry conditions: Brain Tumor Adult, Brain Metastases From Solid Tumors, Brain Tumor, Primary, Brain Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • 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

Primary outcome measures

  • Mean change in serum Amyloid-beta peptide (Aβ) [Time frame: Up to 12 months]
  • Mean change in serum Amyloid-beta peptide (Aβ) by APOE genotype [Time frame: 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) [Time frame: Up to 18 months from date of first radiation dose]
  • Mean change in serum Glial Fibrillary Acidic Protein (GFAP) [Time frame: Up to 12 months]
  • Mean change in serum Glial Fibrillary Acidic Protein (GFAP) by APOE genotype [Time frame: Up to 12 months]
  • Mean change in serum Phosphorylated TAU (p-TAU) [Time frame: Up to 12 months]
  • Mean change in serum Phosphorylated TAU (p-TAU) by APOE genotype [Time frame: Up to 12 months]
  • Mean change in serum Neurofilament Light Chain (NfL) [Time frame: Up to 12 months]
  • Mean change in serum Neurofilament Light Chain (NfL) by APOE genotype [Time frame: Up to 12 months]
  • Mean change in Brain Health Assessment by APOE genotype [Time frame: Up to 12 months]
Secondary outcome measures (1)
  • Change in scores on the European Organization for Research and Treatment of Cancer quality of life questionnaire 30 (EORTC-QLQ-C30) over time [Time frame: Up to 18 months from date of first radiation dose]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT07226466 · 249213 · NCI-2025-01532

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗