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Active, Not Recruiting

NCT Number: NCT02481336

To Study the Individual Variants of Chemotherapy-Induced Neurotoxicity

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

questionnaires

Other

EORTC CIPN20 and EQ-5D-3L

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

Primary outcomes

  1. Adverse events occurring after chemotherapy based on genomic profiling

    Time frame: up to 2 years after chemotherapy

Secondary outcomes

  1. Changes in quality-of-life measured by EORTC CIPN20

    Time frame: up to 2 years after chemotherapy

  2. Changes in quality-of-life measured by EQ-5D-3L

    Time frame: up to 2 years after chemotherapy

  3. Change from Baseline in nerve conduction velocity (NCV)

    Time frame: up to 2 years after chemotherapy

  4. Change from Baseline in quantitative sensory test (QST)

    Time frame: up to 2 years after chemotherapy

  5. Change from Baseline in nerve excitability test (NET)

    Time frame: up to 2 years after chemotherapy

  6. Relapse-free survival

    Time frame: up to 5 years after chemotherapy

  7. Overall Survival

    Time frame: up to 5 years after chemotherapy

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2029
Study completion
2029
First posted
Jun 25, 2015
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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