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NCT Number: NCT07226466

Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Location contact

Jean Nakamura, MD

CONTACT

[email protected]

877-827-3222

About this study

PRIMARY OBJECTIVES:

  • Assess plasma biomarkers for Aβ, GFAP, phospho Tau, and NfL pre- and post-radiotherapy.
  • Determine APOE genotype.
  • Evaluate neuropsychiatric testing aligned with standard of care brain MRIs and serum markers.
  • Measure brain morphometrics pre- and post-radiotherapy with standard of care brain MRIs.

SECONDARY OBJECTIVES:

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood sample

Procedure

Blood sample will be collected

Brain Magnetic Resonance Imaging (MRI)

Procedure

Brain MRI will be performed during the course of data collection

Brain Health Assessment

Procedure

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

Quality of Life (QoL) Questionnaire

Radiation

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

Primary outcomes

  1. Mean change in serum Amyloid-beta peptide (Aβ)

    Time frame: Up to 12 months

    Mean change in biomarker for Aβ over time will be reported

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

    Time frame: Up to 12 months

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

  3. 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

    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.

  4. Mean change in serum Glial Fibrillary Acidic Protein (GFAP)

    Time frame: Up to 12 months

    Mean change in biomarker for GFAP over time will be reported

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

    Time frame: Up to 12 months

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

  6. Mean change in serum Phosphorylated TAU (p-TAU)

    Time frame: Up to 12 months

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

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

    Time frame: Up to 12 months

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

  8. Mean change in serum Neurofilament Light Chain (NfL)

    Time frame: Up to 12 months

    Mean change in biomarker for NfL over time will be reported

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

    Time frame: Up to 12 months

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

  10. Mean change in Brain Health Assessment by APOE genotype

    Time frame: Up to 12 months

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

  11. Mean change in Hippocampal Volume

    Time frame: Up to 12 months

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

  12. Mean change in Hippocampal Volume by APOE genotype

    Time frame: Up to 12 months

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

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

    Time frame: Up to 18 months from date of first radiation dose

    The functional domains measure the quality of life in Physical functioning, Role functioning, Emotional functioning, Cognitive functioning, Social functioning. Scores consists of responses to items with responses ranging from 1="Not at all" to 4="Very Much". The raw score is calculated by estimating the mean of the items that make up each domains with a resulting total range of 1 - 4. These scores are then transformed to standardized scale score, so that scores range from 0 to 100. A high score for the functional domains represents a high level of functioning.

Study contacts

Contact information is provided by the study sponsor or research team.

Jean Nakamura, MD

CONTACT

[email protected]

(415) 514-4997

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 10, 2025
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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