To Study the Individual Variants of Chemotherapy-Induced Neurotoxicity

Study Overview
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Brief Summary
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To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the clinical bioinformatics and genomic profile.

Detailed Description
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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.

Official Title
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Integrating Clinical and Genomic Profiles for Prediction and Prevention of Chemotherapy-induced Neuropathy Via Big Bio-Data Analytics

Conditions
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Neurotoxicity Syndromes

Intervention / Treatment
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* Other: Questionnaires
* Procedure: Peripheral nervous system examination
* Genetic: Whole Genome Sequence


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Hepatic: Total bilirubin level ≤ 1.0 x UNL AST and ALT ≤ 3.0 x UNL Renal: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer patients receiving chemotherapy<br>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 | Other: Questionnaires<br>* EORTC CIPN20 and EQ-5D-3L<br>Procedure: Peripheral nervous system examination<br>* nerve conduction velocity (NCV), quantitative sensory test (QST), and nerve excitability test (NET)<br>Genetic: Whole Genome Sequence<br>* Genetic Test : 10 mL blood will be collected in Blood Sample Collection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events occurring after chemotherapy based on genomic profiling |  | up to 2 years after chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 nerve conduction velocity (NCV) |  | 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 | 
| Relapse-free survival |  | up to 5 years after chemotherapy | 
| Overall Survival |  | up to 5 years after chemotherapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chemotherapy, Peripheral Neuropathy