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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-01532 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) |
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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.
PRIMARY OBJECTIVES:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with Brain Tumor Receiving Radiotherapy | The 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample | Procedure | Blood sample will be collected |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in serum Amyloid-beta peptide (Aβ) | Mean change in biomarker for Aβ over time will be reported | Up to 12 months |
| 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 | 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) | 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. | Up to 18 months from date of first radiation dose |
| Mean change in serum Glial Fibrillary Acidic Protein (GFAP) | Mean change in biomarker for GFAP over time will be reported | Up to 12 months |
| 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 | Up to 12 months |
| Mean change in serum Phosphorylated TAU (p-TAU) | Mean change in biomarker for p-TAU over time will be reported |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with brain cancers receiving care at University of California, San Francisco (UCSF)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jean Nakamura, MD | Contact | (415) 514-4997 | Jean.Nakamura@ucsf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jean Nakamura, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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Blood samples will be obtained.
| 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 |
|
| Up to 12 months |
| 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 | Up to 12 months |
| Mean change in serum Neurofilament Light Chain (NfL) | Mean change in biomarker for NfL over time will be reported | Up to 12 months |
| 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 | Up to 12 months |
| Mean change in Brain Health Assessment by APOE genotype | Mean change in of Brain Health Assessment by APOE genotype over time will be reported | Up to 12 months |
| Mean change in Hippocampal Volume | Mean change in Hippocampal Volume as measured by MRI over time will be reported | Up to 12 months |
| 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 | Up to 12 months |
| Up to 18 months from date of first radiation dose |
| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D011788 | Quality of Life |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D006304 | Health Status |
| D003710 | Demography |
| D015991 | Epidemiologic Measurements |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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