Evaluating Biomarkers of Cognitive Dysfunction in Patients With Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Mean change in serum Phosphorylated TAU (p-TAU)
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVES:
- Assess plasma biomarkers for Aβ, GFAP, phospho Tau, and NfL pre- and post-radiotherapy.
- Determine APOE genotype.
- Evaluate neuropsychiatric testing aligned with standard of care brain MRIs and serum markers.
- 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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 18 years old
- •Diagnosis of a primary brain tumor OR #
- •Not both #2 and #
- •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
- •Estimated life expectancy post-treatment of > 2 years.
排除标准
- •Diagnosis of neurodegenerative disease (Alzheimer's disease, Parkinson's disease).
- •Diagnosis of memory disorder pre-treatment.
- •Leptomeningeal disease or disease involving either hippocampus.
研究组 & 干预措施
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.
干预措施: Blood sample (Procedure)
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.
干预措施: Brain magnetic resonance imaging (MRI) (Procedure)
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.
干预措施: Brain Health Assessment (Procedure)
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.
干预措施: Quality of Life (QoL) Questionnaire (Radiation)
结局指标
主要结局
Mean change in serum Phosphorylated TAU (p-TAU)
时间窗: 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
时间窗: 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)
时间窗: Up to 12 months
Mean change in biomarker for NfL over time will be reported
Mean change in serum Amyloid-beta peptide (Aβ)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: Up to 12 months
Mean change in biomarker for GFAP by APOE genotype over time will be reported
Mean change in serum Neurofilament Light Chain (NfL) by APOE genotype
时间窗: 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
时间窗: Up to 12 months
Mean change in of Brain Health Assessment by APOE genotype over time will be reported
Mean change in Hippocampal Volume
时间窗: Up to 12 months
Mean change in Hippocampal Volume as measured by MRI over time will be reported
Mean change in Hippocampal Volume by APOE genotype
时间窗: Up to 12 months
Mean change in Hippocampal Volume as measured by MRI by APOE genotype over time will be reported
次要结局
- 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)