Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-28 @ 1:27 AM
Study NCT ID:
NCT01451034
Status:
COMPLETED
Last Update Posted:
2011-10-13
First Post:
2011-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Outcomes of Endoscopic Resection for Treating WHYX Lesion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 872}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-12', 'studyFirstSubmitDate': '2011-09-28', 'studyFirstSubmitQcDate': '2011-10-12', 'lastUpdatePostDateStruct': {'date': '2011-10-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complete resection rate', 'timeFrame': '6 months after endoscopical resection', 'description': 'Complete resection was defined to have all of the following features: 1. grossly en bloc resection, 2. Tumor-free lateral and vertical resection margins, 3. No lymphovascular invasion, and 5. A depth of submucosal tumor invasion of less than 500 micrometers.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['WHYX lesion', 'endoscopic resection', 'complete resection', 'complete resection rate', 'endoscopic feature', 'Average size discrepancy'], 'conditions': ['WHYX Lesion', 'Extremely Well Differentiated Intestinal-type Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'Endoscopically, WHYX cancers demonstrated a vague extent of tumor spread due to pale color changes in both the background atrophic and metaplastic gastric mucosa. However, the clinical outcomes of WHYX cancers after endoscopic resection are unknown. The aim of this study was to evaluate clinical outcomes of WHYX cancers after endoscopic resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* From January 2009 to December 2010 enrolled 872 patients with EGC\n\nExclusion Criteria:\n\n* EGC with regional lymph node metastasis in radiologic finding endoscopically suspicious submucosal invasion'}, 'identificationModule': {'nctId': 'NCT01451034', 'briefTitle': 'Clinical Outcomes of Endoscopic Resection for Treating WHYX Lesion', 'organization': {'class': 'OTHER', 'fullName': 'Samsung Medical Center'}, 'officialTitle': 'Clinical Outcomes of Endoscopic Resection for Treating Extremely Well Differentiated Intestinal-type Adenocarcinoma (WHYX Lesion)', 'orgStudyIdInfo': {'id': '2011-08-022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'WHYX cancer group', 'description': 'WHYX cancer diagnosed by pathologic report', 'interventionNames': ['Procedure: WHYX cancer group']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'non-WHYX cancer group', 'description': 'all cancer except WHYX cancer diagnosed by pathologic report', 'interventionNames': ['Procedure: WHYX cancer group']}], 'interventions': [{'name': 'WHYX cancer group', 'type': 'PROCEDURE', 'description': 'WHYX cancer diagnosed by pathologic report', 'armGroupLabels': ['WHYX cancer group', 'non-WHYX cancer group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '135-710', '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': 'SPONSOR'}}}}