Ignite Creation Date:
2024-05-06 @ 9:37 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03030508
Status:
UNKNOWN
Last Update Posted:
2017-01-25
First Post:
2017-01-13
Brief Title:
Discovery and Validate of Multi-genetic Biomarkers for Capecitabine in Chinese Colorectal Patients
Sponsor:
Shanghai Changzheng Hospital
Organization:
Shanghai Changzheng Hospital
Study Overview
Official Title:
Discovery and Validate of Multi-genetic Biomarkers for Capecitabine in Chinese Colorectal Patients
Status:
UNKNOWN
Status Verified Date:
2017-01
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
At present chemotherapy is widely used in the adjuvant treatment of colorectal cancer patients after surgery Capecitabine is one of the main chemotherapeutic drugs But the effect is not good enough the adverse reaction is serious and the individual differences were significant The present study shows that these problems are related to the differences in the exposure of capecitabine and its metabolites in different patients The genetic biomarkers for capecitabine include DRD MTHFR and TYMS Mutations in these genes directly affect the expression of metabolic enzymes involved in capecitabine and control the concentration of capecitabine and its metabolites However these markers have been obtained through clinical trials in the United States and their role in predicting the effectiveness or safety of capecitabine and its metabolites has not been validated in Chinese cancer patientsThe study was based on a case study of patients with colorectal cancer in China and capecitabine as the primary postoperative chemotherapy regimen to verify whether the available biomarkers can be used to predict the effectiveness and safety of capecitabine To clarify the effect of capecitabine on endogenous metabolites and to study the mechanism of its effect so as to discover new biomarkers
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