Clinical Trial: To Study the Individual Variants of Chemotherapy-Induced Neurotoxicity

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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

Detailed Summary: 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.
Sponsor: National Cheng-Kung University Hospital

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: National Cheng-Kung University Hospital

Dates:
Date Received: June 9, 2015
Date Started: March 2015
Date Completion: March 2020
Last Updated: April 1, 2016
Last Verified: April 2016