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Discovery and Validate of Multi-genetic Biomarkers for Capecitabine in Chinese Colorectal Patients

NCT03030508 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2017-01-25

No results posted yet for this study

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 patients.The 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.

Conditions

Interventions

OTHER

No intervention

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    collaborator OTHER

  • Shanghai Minhang Central Hospital

    collaborator OTHER

  • Xuzhou Medical University

    collaborator OTHER

  • The 97 Hospital of chinese PLA

    collaborator UNKNOWN

  • Changhai Hospital

    collaborator OTHER

  • Shanghai Changzheng Hospital

    lead OTHER

Principal Investigators

  • Wansheng Chen, PhD · Department of medicine of Shanghai Changzheng Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2019-01-31
Completion
2019-03-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03030508 on ClinicalTrials.gov