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: 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.
Study Type
OBSERVATIONAL
Enrollment
40
Blood sample will be collected
Brain MRI will be performed during the course of data collection
Brain Health Assessment will be performed during the course of data collection
University of California, San Francisco
San Francisco, California, United States
Mean change in serum Amyloid-beta peptide (Aβ)
Mean change in biomarker for Aβ over time will be reported
Time frame: 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
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)
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.
Time frame: 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
Time frame: 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
Time frame: Up to 12 months
Mean change in serum Phosphorylated TAU (p-TAU)
Mean change in biomarker for p-TAU over time will be reported
Time frame: Up to 12 months
Mean change in serum Phosphorylated TAU (p-TAU) by APOE genotype
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QoL questionnaire will be given to participants during the course of data collection
Mean change in biomarker for p-TAU by APOE genotype over time will be reported
Time frame: Up to 12 months
Mean change in serum Neurofilament Light Chain (NfL)
Mean change in biomarker for NfL over time will be reported
Time frame: 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
Time frame: 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
Time frame: Up to 12 months
Mean change in Hippocampal Volume
Mean change in Hippocampal Volume as measured by MRI over time will be reported
Time frame: 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
Time frame: Up to 12 months
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.
Time frame: Up to 18 months from date of first radiation dose