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Brain Tumor AdultNCT07226466

Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer

An observational study of Brain Tumor Adult and Brain Metastases From Solid Tumors, run by University of California, San Francisco at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Blood sample, Brain magnetic resonance imaging (MRI) and Brain Health Assessment
Type of treatment
Surgery or procedure
How many people
40 participants
Where
1 siteUnited States
Study dates
15 Dec 2026to 28 Feb 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • >= 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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jean Nakamura, MD contact

(415) 514-4997

Jean.Nakamura@ucsf.edu

United States1 site

  • University of California, San Francisco

    San Francisco, California, 94143

    Jean Nakamura, MD, 877-827-3222, cancertrials@ucsf.edu

Other trials in United States

About this study

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.

Read the 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.

Being tested
Blood sample, Brain magnetic resonance imaging (MRI), Brain Health Assessment, Quality of Life (QoL) Questionnaire
Medical subject headings
Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampleProcedure or surgery

    Blood sample will be collected

  • Brain magnetic resonance imaging (MRI)Procedure or surgery

    Brain MRI will be performed during the course of data collection

  • Brain Health AssessmentProcedure or surgery

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

  • Quality of Life (QoL) QuestionnaireRadiation

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

Study groups in NCT07226466
Study groupRoleWhat they receive
Adults with Brain Tumor Receiving RadiotherapyThe 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.
Receives: Procedure: Blood sample; Procedure: Brain magnetic resonance imaging (MRI); Procedure: Brain Health Assessment; Radiation: Quality of Life (QoL) Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Mean change in biomarker for Aβ over time will be reported

    Measured: Up to 6 months

  2. 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

    Measured: Up to 6 months

  3. 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.

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

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

    Mean change in biomarker for GFAP over time will be reported

    Measured: Up to 6 months

  5. 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

    Measured: Up to 6 months

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

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

    Measured: Up to 6 months

  7. 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

    Measured: Up to 6 months

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

    Mean change in biomarker for NfL over time will be reported

    Measured: Up to 6 months

  9. 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

    Measured: Up to 6 months

  10. Mean change in Brain Health Assessment by APOE genotype

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

    Measured: Up to 6 months

  11. Mean change in Hippocampal Volume

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

    Measured: Up to 6 months

  12. 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

    Measured: Up to 6 months

Secondary outcomes (1)

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

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Nov 2025
  2. Study start15 Dec 2026 (estimated)
  3. Primary completion28 Feb 2029 (estimated)
  4. Study completion28 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07226466
Sponsor's protocol ID
249213
Other IDs
NCI-2025-01532
Status last verified
Oct 2026
First submitted
6 Nov 2025
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Brain Tumor Adult and Brain Metastases From Solid Tumors, run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jean Nakamura, MD ((415) 514-4997, Jean.Nakamura@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in serum Amyloid-beta peptide (Aβ) (time frame: Up to 6 months). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07226466.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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