Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2026-01-01 @ 10:55 PM
Study NCT ID:
NCT03400657
Status:
UNKNOWN
Last Update Posted:
2018-01-17
First Post:
2018-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MDT to Evaluate the Survival Benefit of Patients With Advanced Gastric / Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 484}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2020-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-01-09', 'studyFirstSubmitDate': '2018-01-02', 'studyFirstSubmitQcDate': '2018-01-09', 'lastUpdatePostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months', 'description': 'From date of enrollment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months'}], 'secondaryOutcomes': [{'measure': 'Differences in overall survival after performing MDT at center', 'timeFrame': '1 years', 'description': 'Differences in overall survival after performing MDT at center'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multi-disciplinary Treatment']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multicenter, non-interventional, controlled clinical study. Evaluate MDT performance and benefit analysis in patients with advanced gastric or colorectal cancer after MDT discussion under real medical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'recurrent / metastatic gastric or colorectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histopathological diagnosis of recurrent / metastatic gastric or colorectal cancer.\n2. Participate in formal MDT discussions at the Research Center.\n3. MDT decision-making at least two subjects involved in treatment.\n4. Patient informed consent and signed written consent.\n\nExclusion Criteria:\n\n1. Early or locally advanced gastric cancer or colorectal cancer.\n2. Accept informal MDT discussions.\n3. MDT decisions recommend only a single subject for treatment of patients.\n4. MDT decisions recommend only palliative patients.'}, 'identificationModule': {'nctId': 'NCT03400657', 'briefTitle': 'MDT to Evaluate the Survival Benefit of Patients With Advanced Gastric / Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking University'}, 'officialTitle': 'A Prospective, Multicenter, Prospective, Non-intervention, Controlled Trial of MDT to Evaluate the Survival Benefit of Patients With Advanced Gastric / Colorectal Cancer in Realistic Medical Practice', 'orgStudyIdInfo': {'id': 'CSMDT-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'fully implemented to the MDT decision', 'description': 'group of patients fully implemented to the MDT decision', 'interventionNames': ['Procedure: Multi-disciplinary Treatment']}, {'label': 'not completly implemented to the MDT-decision', 'description': 'group of patients not completly implemented to the MDT decision', 'interventionNames': ['Procedure: Multi-disciplinary Treatment']}, {'label': 'not implemented to the MDT decision', 'description': 'group of patients not implemented to the MDT decision', 'interventionNames': ['Procedure: Multi-disciplinary Treatment']}], 'interventions': [{'name': 'Multi-disciplinary Treatment', 'type': 'PROCEDURE', 'description': 'due to suggestion of Multi-disciplinary Treatment ,the patients would be suggested to chemotherapy or surgery.', 'armGroupLabels': ['fully implemented to the MDT decision', 'not completly implemented to the MDT-decision', 'not implemented to the MDT decision']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100142', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Cancer Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of department of Gastroentestinal oncology', 'investigatorFullName': 'Shen Lin', 'investigatorAffiliation': 'Peking University'}}}}