Pharmacogenomic Study (Adjuvant Chemotherapy)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 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: June 12, 2013
Last verified: June 2013
  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:


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 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: June 12, 2013
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

ClinicalTrials.gov processed this record on July 10, 2014