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Pharmacogenomic Study (Adjuvant Chemotherapy)

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ClinicalTrials.gov Identifier: NCT01470404
Recruitment Status : Completed
First Posted : November 11, 2011
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center

Brief Summary:

To assess the role of germline polymorphisms in xenobiotic metabolism genes in toxicity profile.

To assess the role of germline polymorphisms in genes associated with DNA repair, p53 tumor suppressor gene and angiogenesis pathway in predicting recurrence and survival in gastric cancer patients treated with adjuvant chemotherapy.


Condition or disease
Gastric Cancer

Study Type : Observational
Actual Enrollment : 792 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacogenomic Study to Predict Toxicity and Response in Gastric Cancer Patients Treated With Adjuvant Chemotherapy
Actual Study Start Date : July 10, 2008
Actual Primary Completion Date : May 10, 2013
Actual Study Completion Date : July 10, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Group/Cohort
adjuvant chemotherapy
Patients enrolled on to the adjuvant XP trial + patients who received adjuvant chemotherapy following curative resection of gastric cancer



Primary Outcome Measures :
  1. germline polymorphisms in xenobiotic metabolism genes in toxicity profile [ Time Frame: 36 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients enrolled on to the adjuvant trial will be considered as candidates for the study. Once the patient signed written informed consent, 10cc blood will be drawn in EDTA tube for DNA extraction.
Criteria

Inclusion Criteria:

  • gastric cancer patients treated with adjuvant chemotherapy

Exclusion Criteria:


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): NCT01470404


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: won ki kang, MD Samsung Medical Center

Responsible Party: Won Ki Kang, Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01470404     History of Changes
Other Study ID Numbers: 2008-05-053
First Posted: November 11, 2011    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases