Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-03 @ 8:24 PM
Study NCT ID:
NCT03639792
Status:
COMPLETED
Last Update Posted:
2020-05-22
First Post:
2018-08-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Escorting Octogenarian for Gastric Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 61}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-21', 'studyFirstSubmitDate': '2018-08-17', 'studyFirstSubmitQcDate': '2018-08-17', 'lastUpdatePostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Morbidity and mortality', 'timeFrame': 'One month after hospital discharge', 'description': 'Postoperative Morbidity and mortality according to standard definition'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'upto two years', 'description': 'Overall survival'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric cancer', 'postoperative complication', 'octogenarian'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'An objective analysis of postoperative complications is vital to escort octogenarian for gastric cancer surgery. Investigator carefully collected clinical data prospectively to pave way for standard management in high risk patients.', 'detailedDescription': 'An objective analysis of postoperative complications is vital to escort octogenarian for gastric cancer surgery. Investigator carefully collected clinical data prospectively to pave way for standard management in high risk patients. Detailed data on surgical indication, assessment for proposed surgery and perioperative management are analyzed for future guidelines in senile.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '80 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'A cohort of gastric cancer patients who underwent surgery during two consecutive years in a Chinese hospital.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Pathologically confirmed gastric cancer patients Clinically fit for gastric cancer surgery\n\nExclusion Criteria:\n\n\\- Non gastric cancer patients Clinically unfit for gastric cancer surgery'}, 'identificationModule': {'nctId': 'NCT03639792', 'briefTitle': 'Escorting Octogenarian for Gastric Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Escorting Octogenarian for Gastric Cancer Surgery', 'orgStudyIdInfo': {'id': 'RJ-GC-Postop-complication 2'}}, 'armsInterventionsModule': {'interventions': [{'name': 'gastric cancer surgery', 'type': 'PROCEDURE', 'description': 'Gastric cancer surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '200025', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Ruijin Hospital Shanghai Jiaotong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Birendra K Sah, Ph D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ruijin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Surgeon', 'investigatorFullName': 'BIRENDRA KUMAR SAH', 'investigatorAffiliation': 'Ruijin Hospital'}}}}