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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03030508
Recruitment Status : Unknown
Verified January 2017 by Wansheng Chen, Shanghai Changzheng Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : January 25, 2017
Last Update Posted : January 25, 2017
Sponsor:
Collaborators:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai Minhang Central Hospital
Xuzhou Medical University
The 97 Hospital of chinese PLA
Changhai Hospital
Information provided by (Responsible Party):
Wansheng Chen, Shanghai Changzheng Hospital

Study Description
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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
Colorectal Cancer Capecitabine Other: No intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Discovery and Validate of Multi-genetic Biomarkers for Capecitabine in Chinese Colorectal Patients
Study Start Date : January 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
Group cap
Patients receiving capecitabine chemotherapy after operation
 Other: No intervention


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: during chemotherapy ]
    Adverse Events That Are Related to Treatment

  2. Disease-free survival [ Time Frame: Three year disease-free survival ]

Secondary Outcome Measures :
  1. Three year disease free survival rate [ Time Frame: Three year disease free survival rate ]

Biospecimen Retention:   Samples With DNA
tissue,blood,urine and stool sample

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
300 patients with colorectal cancer receiving first chemotherapy after surgery
Criteria

Inclusion Criteria:

  1. more than 18 years old;
  2. patients with colon cancer diagnosed by biopsy (regardless of cancer stage);
  3. received postoperative containing capecitabine chemotherapy;
  4. volunteer to participate in the experiment

Exclusion Criteria:

  1. pregnant and lactating women;
  2. patients with hypersensitivity to fluorouracil or severe metabolic failure;
  3. patients with severe infection;
  4. patients with other cancers other than colorectal cancer within the first five years of colorectal cancer surgery;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03030508


Locations
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China, Shanghai
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
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Study Chair: Wansheng Chen, PhD Department of medicine of Shanghai Changzheng Hospital
More Information
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Publications:

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Responsible Party: Wansheng Chen, Professor, Director of Department of Pharmacy, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT03030508    
Other Study ID Numbers: WChen
First Posted: January 25, 2017    Key Record Dates
Last Update Posted: January 25, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wansheng Chen, Shanghai Changzheng Hospital:
biomarks
colorectal cancer
capecitabine
gene polymorphism
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases