Viewing Study NCT03252834



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Last Modification Date: 2024-10-26 @ 12:29 PM
Study NCT ID: NCT03252834
Status: TERMINATED
Last Update Posted: 2022-04-14
First Post: 2017-08-15

Brief Title: Genetic Variants and Chemotherapy-induced Abnormal Thermal Sensation
Sponsor: National Cheng-Kung University Hospital
Organization: National Cheng-Kung University Hospital

Study Overview

Official Title: To Study the Individual Variants of Chemotherapy-induced Abnormal Thermal Sensation in Cancer Patients
Status: TERMINATED
Status Verified Date: 2022-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Poor enrollment
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This is a prospective single arm single center study evaluating the use of a 4-gene panel to predict the occurrence of chemotherapy-induced abnormal thermal threshold in endometrial and ovarian cancer patients receiving post-operative chemotherapy with CarboplatinPaclitaxel and stage III colorectal cancer patients receiving adjuvant chemotherapy with mFOLFOX6 A total of 100 patients will be enrolled during 2017 July 2019 June Blood sample will be collected before chemotherapy to analyze the genetic variants of TRPV1 TRPM2 TRPA1 and ORAI1 All patients will receive neurologic examination Quantitative Sensory Test QST and complete the questionnaires for quality of life EQ5D CIPN20 The primary endpoint of this study is to test if the genetic variant of TRPV1 TRPM2 TRPA1 and ORAI1 is a predictive biomarker for the chemotherapy-induced abnormal thermal sensation in cancer patients
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None