Discovery and Validate of Multi-genetic Biomarkers for Capecitabine in Chinese Colorectal Patients
Study Details
Study Description
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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group cap Patients receiving capecitabine chemotherapy after operation |
Other: No intervention
|
Outcome Measures
Primary Outcome Measures
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [during chemotherapy]
Adverse Events That Are Related to Treatment
- Disease-free survival [Three year disease-free survival]
Secondary Outcome Measures
- Three year disease free survival rate [Three year disease free survival rate]
Eligibility Criteria
Criteria
Inclusion Criteria:
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more than 18 years old;
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patients with colon cancer diagnosed by biopsy (regardless of cancer stage);
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received postoperative containing capecitabine chemotherapy;
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volunteer to participate in the experiment
Exclusion Criteria:
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pregnant and lactating women;
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patients with hypersensitivity to fluorouracil or severe metabolic failure;
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patients with severe infection;
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patients with other cancers other than colorectal cancer within the first five years of colorectal cancer surgery;
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of medicine of Shanghai Changzheng Hospital | Shanghai | Shanghai | China | 200003 |
Sponsors and Collaborators
- Shanghai Changzheng Hospital
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Shanghai Minhang Central Hospital
- Xuzhou Medical University
- The 97 Hospital of chinese PLA
- Changhai Hospital
Investigators
- Study Chair: Wansheng Chen, PhD, Department of medicine of Shanghai Changzheng Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
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- Zhang X, Sun B, Lu Z. Evaluation of clinical value of single nucleotide polymorphisms of dihydropyrimidine dehydrogenase gene to predict 5-fluorouracil toxicity in 60 colorectal cancer patients in China. Int J Med Sci. 2013 May 20;10(7):894-902. doi: 10.7150/ijms.5556. Print 2013.
- WChen