Brain Tumor Adult, Brain Metastases From Solid Tumors, Brain Tumor, Primary, Brain Tumor
Conditions
Brief 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. Standard brain radiotherapy is known to impact cognitive outcomes, yet the underlying biological mechanisms remain unclear.
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.
Interventions
PROCEDUREBlood sample
Blood sample will be collected
Brain MRI will be performed during the course of data collection
PROCEDUREBrain Health Assessment
Brain Health Assessment will be performed during the course of data collection
RADIATIONQuality of Life (QoL) Questionnaire
QoL questionnaire will be given to participants during the course of data collection
Sponsors
University of California, San Francisco
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>= 18 years old 2. Diagnosis of a primary brain tumor OR #3. Not both #2 and #3. 3. Diagnosis of primary solid tumor and secondary involvement of the brain 4. If the patient has brain metastases: fewer than 5 brain metastases (post-operative and definitive allowed), none \> 1 cm in max diameter. 5. Candidate for standard of care / usual care (SOC) focused brain radiotherapy. 6. No prior brain radiotherapy, including whole brain radiotherapy. 7. Eastern Cooperative Oncology Group (ECOG) functional score 0 or 1. 8. Estimated life expectancy post-treatment of \> 2 years.
Exclusion criteria
1. Diagnosis of neurodegenerative disease (Alzheimer's disease, Parkinson's disease). 2. Diagnosis of memory disorder pre-treatment. 3. Leptomeningeal disease or disease involving either hippocampus.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in Hippocampal Volume by APOE genotype | Up to 12 months | Mean change in Hippocampal Volume as measured by MRI by APOE genotype over time will be reported |
| 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 genotype | Up 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 genotype | Up 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 genotype | Up 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 genotype | Up 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 genotype | Up to 12 months | Mean change in of Brain Health Assessment by APOE genotype over time will be reported |
| Mean change in Hippocampal Volume | Up to 12 months | Mean change in Hippocampal Volume as measured by MRI over time will be reported |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in scores on the European Organization for Research and Treatment of Cancer quality of life questionnaire 30 (EORTC-QLQ-C30) over time | 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. |
Countries
United States
Contacts
Primary ContactJean Nakamura, MD
Outcome results
None listed