Integrating Clinical and Genomic Profiles for Prediction and Prevention of Chemotherapy-induced Neuropathy Via Big Bio-Data Analytics
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Adverse events occurring after chemotherapy based on genomic profiling
研究概览
简要总结
To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the clinical bioinformatics and genomic profile.
详细描述
This is a prospective, observational, cohort study, monitoring the chemotherapy-induced peripheral neurotoxicity by traditional clinical scales, neurological examinations, and semi-quantitative assessments. Moreover, all the genetic changes will be analyzed by next generation sequencing and we will try to identify relevant variants in individuals who suffer from chemotherapy-induced neurotoxicity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed epithelial ovarian cancer, endometrial cancer or adenocarcinoma of colon or rectum
- •Pathological stage I~IV for ovarian cancer, stage II~IV endometrial cancer or stage III & high risk stage II for colorectal cancer
- •Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer
- •Age ≥ 20 years old
- •ECOG Performance status 0-1
- •Adequate organ function
- •Bone marrow:
- •Absolute neutrophil count (ANC) ≥ 1.5 x 109/L WBC ≥ 3.0 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin ≥ 9 g/dL
- •Total bilirubin level ≤ 1.0 x UNL AST and ALT ≤ 3.0 x UNL
- •Creatinine level ≤ 1.5 mg/dL in men, ≤1.4 mg/dL in women; or Estimated CCr ≥ 60 mL/min (CCr is estimated by Cockcroft-Gault formula, as appendix III).
- •Negative pregnancy test for women of childbearing potential only
- •Patient willing to provide blood sample for research purposes
- •Written informed consent
排除标准
- •Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids
- •Receiving chemotherapy within 6 months
- •History of allergy to 5-FU or LV
- •Pre-existing peripheral neuropathy of any grade
- •A family history of a genetic or familial neuropathy
- •Active uncontrolled infection
- •Significant medical diseases, such as unstable angina, acute or recent myocardial infarction (<6 months before enrollment), COPD with frequent exacerbation, uncontrolled hypertension, ore cent CVA (<6 months before enrollment)
- •Poor compliance
研究组 & 干预措施
Cancer patients receiving chemotherapy
Stage I-IV ovarian cancer receiving chemotherapy Paclitaxel/Carboplatin
Stage II-IV endometrial cancer receiving chemotherapy Paclitaxel/Carboplatin
Stage III & high risk stage II colorectal cancer receiving chemotherapy with mFOLFOX
- Questionnaires
- Peripheral nervous system examination
- Whole Genome Sequence
干预措施: Whole Genome Sequence (Genetic)
Cancer patients receiving chemotherapy
Stage I-IV ovarian cancer receiving chemotherapy Paclitaxel/Carboplatin
Stage II-IV endometrial cancer receiving chemotherapy Paclitaxel/Carboplatin
Stage III & high risk stage II colorectal cancer receiving chemotherapy with mFOLFOX
- Questionnaires
- Peripheral nervous system examination
- Whole Genome Sequence
干预措施: Questionnaires (Other)
Cancer patients receiving chemotherapy
Stage I-IV ovarian cancer receiving chemotherapy Paclitaxel/Carboplatin
Stage II-IV endometrial cancer receiving chemotherapy Paclitaxel/Carboplatin
Stage III & high risk stage II colorectal cancer receiving chemotherapy with mFOLFOX
- Questionnaires
- Peripheral nervous system examination
- Whole Genome Sequence
干预措施: Peripheral nervous system examination (Procedure)
结局指标
主要结局
Adverse events occurring after chemotherapy based on genomic profiling
时间窗: up to 2 years after chemotherapy
次要结局
- Relapse-free survival(up to 5 years after chemotherapy)
- Changes in quality-of-life measured by EORTC CIPN20(up to 2 years after chemotherapy)
- Changes in quality-of-life measured by EQ-5D-3L(up to 2 years after chemotherapy)
- Change from Baseline in quantitative sensory test (QST)(up to 2 years after chemotherapy)
- Change from Baseline in nerve excitability test (NET)(up to 2 years after chemotherapy)
- Change from Baseline in nerve conduction velocity (NCV)(up to 2 years after chemotherapy)
- Overall Survival(up to 5 years after chemotherapy)