To Study the Individual Variants of Chemotherapy-Induced Neurotoxicity

Neurotoxicity Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02481336
• Other study ID #: A-ER-103-395
• Status: Active, not recruiting
• Start date: March 2015
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2022
• Source: National Cheng-Kung University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neurotoxicity Syndromes

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (1)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events occurring after chemotherapy based on genomic profiling		up to 2 years after chemotherapy
Secondary	Changes in quality-of-life measured by EORTC CIPN20		up to 2 years after chemotherapy
Secondary	Changes in quality-of-life measured by EQ-5D-3L		up to 2 years after chemotherapy
Secondary	Change from Baseline in nerve conduction velocity (NCV)		up to 2 years after chemotherapy
Secondary	Change from Baseline in quantitative sensory test (QST)		up to 2 years after chemotherapy
Secondary	Change from Baseline in nerve excitability test (NET)		up to 2 years after chemotherapy
Secondary	Relapse-free survival		up to 5 years after chemotherapy
Secondary	Overall Survival		up to 5 years after chemotherapy