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To Study the Individual Variants of Chemotherapy-Induced Neurotoxicity

This study is currently recruiting participants.
Verified August 2017 by National Cheng-Kung University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT02481336
First Posted: June 25, 2015
Last Update Posted: August 18, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cheng-Kung University Hospital
  Purpose
To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the clinical bioinformatics and genomic profile.

Condition Intervention
Neurotoxicity Syndromes Other: Questionnaires Procedure: Peripheral nervous system examination Genetic: Whole Genome Sequence

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Integrating Clinical and Genomic Profiles for Prediction and Prevention of Chemotherapy-induced Neuropathy Via Big Bio-Data Analytics

Resource links provided by NLM:


Further study details as provided by National Cheng-Kung University Hospital:

Primary Outcome Measures:
  • Adverse events occurring after chemotherapy based on genomic profiling [ Time Frame: up to 2 years after chemotherapy ]

Secondary Outcome Measures:
  • Changes in quality-of-life measured by EORTC CIPN20 [ Time Frame: up to 2 years after chemotherapy ]
  • Changes in quality-of-life measured by EQ-5D-3L [ Time Frame: up to 2 years after chemotherapy ]
  • Change from Baseline in nerve conduction velocity (NCV) [ Time Frame: up to 2 years after chemotherapy ]
  • Change from Baseline in quantitative sensory test (QST) [ Time Frame: up to 2 years after chemotherapy ]
  • Change from Baseline in nerve excitability test (NET) [ Time Frame: up to 2 years after chemotherapy ]
  • Relapse-free survival [ Time Frame: up to 5 years after chemotherapy ]
  • Overall Survival [ Time Frame: up to 5 years after chemotherapy ]

Biospecimen Retention:   Samples With DNA
Blood Sample Collection with DNA

Estimated Enrollment: 300
Study Start Date: March 2015
Estimated Study Completion Date: March 2020
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  1. Questionnaires
  2. Peripheral nervous system examination
  3. Whole Genome Sequence
Other: Questionnaires
EORTC CIPN20 and EQ-5D-3L
Procedure: Peripheral nervous system examination
nerve conduction velocity (NCV), quantitative sensory test (QST), and nerve excitability test (NET)
Genetic: Whole Genome Sequence
Genetic Test : 10 mL blood will be collected in Blood Sample Collection

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
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.
Criteria

Inclusion Criteria:

  1. Histologically confirmed epithelial ovarian cancer, endometrial cancer or adenocarcinoma of colon or rectum
  2. Pathological stage I~IV for ovarian cancer, stage II~IV endometrial cancer or stage III & high risk stage II for colorectal cancer
  3. Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer
  4. Age ≥ 20 years old
  5. ECOG Performance status 0-1
  6. 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).

  7. Negative pregnancy test for women of childbearing potential only
  8. Patient willing to provide blood sample for research purposes
  9. Written informed consent

Exclusion Criteria:

  1. Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids
  2. Receiving chemotherapy within 6 months
  3. History of allergy to 5-FU or LV
  4. Pre-existing peripheral neuropathy of any grade
  5. A family history of a genetic or familial neuropathy
  6. Active uncontrolled infection
  7. 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)
  8. Poor compliance
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481336


Contacts
Contact: Meng-Ru Shen, PHD 886-6-2353535 ext 5505 mrshen@mail.ncku.edu.tw

Locations
Taiwan
National Cheng Kung University Hospital Recruiting
Tainan, Taiwan, 704
Contact: Meng-Ru Shen, PHD         
Sponsors and Collaborators
National Cheng-Kung University Hospital
Investigators
Study Chair: Meng-Ru Shen, PHD National Cheng Kung University
  More Information

Responsible Party: National Cheng-Kung University Hospital
ClinicalTrials.gov Identifier: NCT02481336     History of Changes
Other Study ID Numbers: A-ER-103-395
First Submitted: June 9, 2015
First Posted: June 25, 2015
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by National Cheng-Kung University Hospital:
Chemotherapy
Peripheral Neuropathy

Additional relevant MeSH terms:
Neurotoxicity Syndromes
Nervous System Diseases
Poisoning
Chemically-Induced Disorders