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Pharmacogenomic Study (Adjuvant Chemotherapy)

This study is currently recruiting participants.
Verified July 2011 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Won Ki Kang, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01470404
First received: November 9, 2011
Last updated: November 10, 2011
Last verified: July 2011
History of Changes
  Purpose

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
Gastric Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pharmacogenomic Study to Predict Toxicity and Response in Gastric Cancer Patients Treated With Adjuvant Chemotherapy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • germline polymorphisms in xenobiotic metabolism genes in toxicity profile [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: July 2008
Estimated Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
adjuvant chemotherapy
Patients enrolled on to the adjuvant XP trial + patients who received adjuvant chemotherapy following curative resection of gastric cancer

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01470404

Contacts
Contact: mi yeon kwon, RN +82-2-3410-1248 miyeon.kwon@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: mi yeon kwon, RN     +82-2-3410-1248     miyeon.kwon@samsung.com    
Principal Investigator: won ki Kang, MD            
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: won ki kang, MD Samsung Medical Center
  More Information

No publications provided

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
Study First Received: November 9, 2011
Last Updated: November 10, 2011
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Stomach Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013