Association of Genetic Polymorphisms With Capecitabine-based Chemotherapy Toxicities in Chinese Solid Tumor Patients

NCT03258099 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 2200

Last updated 2019-08-28

No results posted yet for this study

Summary

Capecitabine is one of the most active agents in the treatment of many kinds of solid tumors. However, variability in toxicity and response remains a major problem for patients receiving capecitabine. It is general that there are many factors for individual differences of drugs in clinical application, of which genetic factors accounted for more than 20%. Toxicities of capecitabine, such as diarrhea, hand-foot syndrome or anemia, were evaluated for possible relationship with pharmacogenetic polymorphisms in several pharmacogenomics studies. Due to the levels of evidence of those studies are low and lack of sufficient research data of Chinese, it has the important significance in studying individual differences of capecitabine in toxicities, through the pharmacogenomics research.

The aim of this study is to evaluating the association genetic polymorphisms with capecitabine-based chemotherapy toxicities in chinese solid tumor patients. By detecting the gene polymorphism, investigators intend to study the pharmacokinetic/pharmacogenomics (PK-PG) correlation of capecitabine and provide scientific basis for precise medication guide for people to use capecitabine.

Conditions

  • Solid Tumor
  • Capecitabine
  • Drug-Related Side Effects and Adverse Reactions
  • Pharmacogenetics
  • Pharmacokinetics

Interventions

GENETIC

detection of genotype

detection of genotype by next generation sequencing

Sponsors & Collaborators

  • Cui Yimin

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-28
Primary Completion
2019-10-31
Completion
2019-12-31

Countries

  • China

Study Locations

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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 NCT03258099 on ClinicalTrials.gov