Ignite Creation Date:
2025-12-24 @ 9:12 PM
Ignite Modification Date:
2025-12-25 @ 7:01 PM
Study NCT ID:
NCT01470404
Status:
COMPLETED
Last Update Posted:
2018-01-17
First Post:
2011-11-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pharmacogenomic Study (Adjuvant Chemotherapy)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 792}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2013-07-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-15', 'studyFirstSubmitDate': '2011-11-09', 'studyFirstSubmitQcDate': '2011-11-10', 'lastUpdatePostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'germline polymorphisms in xenobiotic metabolism genes in toxicity profile', 'timeFrame': '36 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'To assess the role of germline polymorphisms in xenobiotic metabolism genes in toxicity profile.\n\nTo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gastric cancer patients treated with adjuvant chemotherapy\n\nExclusion Criteria:'}, 'identificationModule': {'nctId': 'NCT01470404', 'briefTitle': 'Pharmacogenomic Study (Adjuvant Chemotherapy)', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Pharmacogenomic Study to Predict Toxicity and Response in Gastric Cancer Patients Treated With Adjuvant Chemotherapy', 'orgStudyIdInfo': {'id': '2008-05-053'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'adjuvant chemotherapy', 'description': 'Patients enrolled on to the adjuvant XP trial + patients who received adjuvant chemotherapy following curative resection of gastric cancer'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'won ki kang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samsung Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samsung Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine, Sungkyunkwan University School of Medicine, Department of Hematology and Oncology', 'investigatorFullName': 'Won Ki Kang', 'investigatorAffiliation': 'Samsung Medical Center'}}}}