- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03030508
Discovery and Validate of Multi-genetic Biomarkers for Capecitabine in Chinese Colorectal Patients
January 22, 2017 updated by: Wansheng Chen, Shanghai Changzheng Hospital
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200003
- Department of medicine of Shanghai Changzheng Hospital
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
300 patients with colorectal cancer receiving first chemotherapy after surgery
Description
Inclusion Criteria:
- more than 18 years old;
- patients with colon cancer diagnosed by biopsy (regardless of cancer stage);
- received postoperative containing capecitabine chemotherapy;
- volunteer to participate in the experiment
Exclusion Criteria:
- pregnant and lactating women;
- patients with hypersensitivity to fluorouracil or severe metabolic failure;
- patients with severe infection;
- patients with other cancers other than colorectal cancer within the first five years of colorectal cancer surgery;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Group cap
Patients receiving capecitabine chemotherapy after operation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
during chemotherapy
|
Disease-free survival
Time Frame: Three year disease-free survival
|
Three year disease-free survival
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Three year disease free survival rate
Time Frame: Three year disease free survival rate
|
Three year disease free survival rate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Wansheng Chen, PhD, Department of medicine of Shanghai Changzheng Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Li F, Qin X, Chen H, Qiu L, Guo Y, Liu H, Chen G, Song G, Wang X, Li F, Guo S, Wang B, Li Z. Lipid profiling for early diagnosis and progression of colorectal cancer using direct-infusion electrospray ionization Fourier transform ion cyclotron resonance mass spectrometry. Rapid Commun Mass Spectrom. 2013 Jan 15;27(1):24-34. doi: 10.1002/rcm.6420.
- Ikeda K, Oike Y, Shimizu T, Taguchi R. Global analysis of triacylglycerols including oxidized molecular species by reverse-phase high resolution LC/ESI-QTOF MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2009 Sep 1;877(25):2639-47. doi: 10.1016/j.jchromb.2009.03.047. Epub 2009 Apr 7.
- Denkert C, Bucher E, Hilvo M, Salek R, Oresic M, Griffin J, Brockmoller S, Klauschen F, Loibl S, Barupal DK, Budczies J, Iljin K, Nekljudova V, Fiehn O. Metabolomics of human breast cancer: new approaches for tumor typing and biomarker discovery. Genome Med. 2012 Apr 30;4(4):37. doi: 10.1186/gm336.
- Wu CW, Ng SS, Dong YJ, Ng SC, Leung WW, Lee CW, Wong YN, Chan FK, Yu J, Sung JJ. Detection of miR-92a and miR-21 in stool samples as potential screening biomarkers for colorectal cancer and polyps. Gut. 2012 May;61(5):739-45. doi: 10.1136/gut.2011.239236. Epub 2011 Sep 19.
- Deenen MJ, Meulendijks D, Cats A, Sechterberger MK, Severens JL, Boot H, Smits PH, Rosing H, Mandigers CM, Soesan M, Beijnen JH, Schellens JH. Upfront Genotyping of DPYD*2A to Individualize Fluoropyrimidine Therapy: A Safety and Cost Analysis. J Clin Oncol. 2016 Jan 20;34(3):227-34. doi: 10.1200/JCO.2015.63.1325. Epub 2015 Nov 16.
- Huang L, Chen F, Chen Y, Yang X, Xu S, Ge S, Fu S, Chao T, Yu Q, Liao X, Hu G, Zhang P, Yuan X. Thymidine phosphorylase gene variant, platelet counts and survival in gastrointestinal cancer patients treated by fluoropyrimidines. Sci Rep. 2014 Jul 16;4:5697. doi: 10.1038/srep05697.
- Xu J, Lin Z, Chen J, Zhang J, Li W, Zhang R, Xing J, Ye Z, Liu X, Gao Q, Chen X, Zhai J, Yao H, Li M, Wei H. Milk and Egg Are Risk Factors for Adverse Effects of Capecitabine-Based Chemotherapy in Chinese Colorectal Cancer Patients. Integr Cancer Ther. 2022 Jan-Dec;21:15347354221105485. doi: 10.1177/15347354221105485.
- Li M, Sun X, Yao H, Chen W, Zhang F, Gao S, Zou X, Chen J, Qiu S, Wei H, Hu Z, Chen W. Genomic methylation variations predict the susceptibility of six chemotherapy related adverse effects and cancer development for Chinese colorectal cancer patients. Toxicol Appl Pharmacol. 2021 Sep 15;427:115657. doi: 10.1016/j.taap.2021.115657. Epub 2021 Jul 29.
- Li M, Chen J, Deng Y, Yan T, Gu H, Zhou Y, Yao H, Wei H, Chen W. Risk prediction models based on hematological/body parameters for chemotherapy-induced adverse effects in Chinese colorectal cancer patients. Support Care Cancer. 2021 Dec;29(12):7931-7947. doi: 10.1007/s00520-021-06337-z. Epub 2021 Jul 2.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Anticipated)
January 1, 2019
Study Completion (Anticipated)
March 1, 2019
Study Registration Dates
First Submitted
January 13, 2017
First Submitted That Met QC Criteria
January 22, 2017
First Posted (Estimate)
January 25, 2017
Study Record Updates
Last Update Posted (Estimate)
January 25, 2017
Last Update Submitted That Met QC Criteria
January 22, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WChen
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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