Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer
This observational study is looking at how brain radiotherapy affects thinking and memory (cognitive function) in adults with primary brain tumors or brain metastases (cancer that has spread to the brain). Researchers want to understand the biological reasons behind these changes. You would have blood samples taken, undergo brain MRI scans, complete brain health assessments, and fill out quality of life questionnaires. The study will measure changes in specific proteins in your blood, like Amyloid-beta peptide (Aβ), and look at your APOE gene type over 12 to 18 months. This will help researchers understand how these factors relate to cognitive changes after radiation.
- Study design
- This is an observational study, meaning no specific treatment is given, and it aims to enroll 40 participants. It is a single-arm, non-randomized, open-label pilot study.
- What's involved
- You would have blood samples collected, brain MRI scans, brain health assessments, and quality of life questionnaires during the study, which lasts up to 12 months post-brain radiotherapy.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your Amyloid-beta peptide (Aβ) levels will be measured for up to 12 months, and your quality of life will be assessed for up to 18 months from your first radiation dose.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jean Nakamura, MD · PRINCIPAL_INVESTIGATOR · University of California, San Francisco
Who to contact
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What this trial measures
- Mean change in serum Amyloid-beta peptide (Aβ)Up to 12 months
Mean change in biomarker for Aβ over time will be reported
- Mean change in serum Amyloid-beta peptide (Aβ) by APOE genotypeUp to 12 months
Mean change in biomarker for Aβ by APOE genotype over time will be reported
- Mean change of score on the European Organization for Research and Treatment of Cancer quality of life questionnaire - Brain Module (EORTC-QLQ-BN20)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.
- Mean change in serum Glial Fibrillary Acidic Protein (GFAP)Up to 12 months
Mean change in biomarker for GFAP over time will be reported
- Mean change in serum Glial Fibrillary Acidic Protein (GFAP) by APOE genotypeUp to 12 months
Mean change in biomarker for GFAP by APOE genotype over time will be reported
- Mean change in serum Phosphorylated TAU (p-TAU)Up to 12 months
Mean change in biomarker for p-TAU over time will be reported
- Mean change in serum Phosphorylated TAU (p-TAU) by APOE genotypeUp to 12 months
Mean change in biomarker for p-TAU by APOE genotype over time will be reported
- Mean change in serum Neurofilament Light Chain (NfL)Up to 12 months
Mean change in biomarker for NfL over time will be reported
- Mean change in serum Neurofilament Light Chain (NfL) by APOE genotypeUp to 12 months
Mean change in biomarker for NfL by APOE genotype over time will be reported
- Mean change in Brain Health Assessment by APOE genotypeUp to 12 months
Mean change in of Brain Health Assessment by APOE genotype over time will be reported
- Mean change in Hippocampal VolumeUp to 12 months
Mean change in Hippocampal Volume as measured by MRI over time will be reported
- Mean change in Hippocampal Volume by APOE genotypeUp to 12 months
Mean change in Hippocampal Volume as measured by MRI by APOE genotype over time will be reported