Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-01 @ 8:39 AM
Study NCT ID:
NCT01498757
Status:
WITHDRAWN
Last Update Posted:
2019-05-21
First Post:
2011-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Genome-wide Association Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077277', 'term': 'Esophageal Squamous Cell Carcinoma'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}, {'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Registration poor', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2012-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-17', 'studyFirstSubmitDate': '2011-12-21', 'studyFirstSubmitQcDate': '2011-12-21', 'lastUpdatePostDateStruct': {'date': '2019-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biomarkers predictive', 'timeFrame': '24months', 'description': 'Biomarkers predictive of clinical response to Taxane or 5-fluorouracil or platinum based chemotherapy.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Esophageal Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'To explore biomarkers predictive of clinical response to Taxane/5-FU/platinum based chemotherapy in esophageal squamous cell carcinoma. To identify negative predictive markers to 5-FU/platinum/Taxane. To elucidate signal transduction pathway attributable to 5-FU/platinum/Taxane resistance. To analyze correlation between the quantity of circulating tumor cells and circulating endothelial cell precursors and treatment response to Taxane/5-FU/platinum based chemotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Esophageal squamous cell carcinoma Patients treated with Taxane/5-FU/platinum based chemotherapy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histological confirmed esophageal squamous cell carcinoma\n* Patients treated with Taxane or 5-FU or platinum based chemotherapy.\n* provision of a signed written informed consent.\n\nExclusion Criteria:\n\n* patients not signed written informed consent.\n* patient unacceptable for study in the judgement of the investigator.'}, 'identificationModule': {'nctId': 'NCT01498757', 'briefTitle': 'Genome-wide Association Study', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Genome-wide Association Study to Predict Treatment Response for Chemotherapy in Esophageal Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': '2011-05-076'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with Taxane/5-FU/platinum based chemo.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, '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': 'Jeeyun Lee', 'investigatorAffiliation': 'Samsung Medical Center'}}}}