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To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the clinical bioinformatics and genomic profile.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | EORTC CIPN20 and EQ-5D-3L |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events occurring after chemotherapy based on genomic profiling | up to 2 years after chemotherapy |
| 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 | |
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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:
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Total 300 cancer patients will be enrolled in National Cheng Kung University Hospital from March, 2015 to March, 2017. The subjects are stage I-IV ovarian cancer patients receiving chemotherapy Paclitaxel/Carboplatin, stage II-IV endometrial cancer patients receiving chemotherapy Paclitaxel/Carboplatin, stage III & high risk stage II colorectal cancer patients receiving chemotherapy with mFOLFOX.
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| Name | Affiliation | Role |
|---|---|---|
| Meng-Ru Shen, PHD | National Cheng Kung University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cheng Kung University Hospital | Tainan | 704 | Taiwan |
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| ID | Term |
|---|---|
| D020258 | Neurotoxicity Syndromes |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D011041 | Poisoning |
| D064419 | Chemically-Induced Disorders |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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Blood Sample Collection with DNA
| Peripheral nervous system examination |
| Procedure |
nerve conduction velocity (NCV), quantitative sensory test (QST), and nerve excitability test (NET) |
|
| Whole Genome Sequence | Genetic | Genetic Test : 10 mL blood will be collected in Blood Sample Collection |
|
| 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 |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |