Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-25 @ 7:54 PM
Study NCT ID:
NCT06103435
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2023-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multivisceral Resections for Locally Advanced Gastric Cancer
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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1476}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2023-10-18', 'studyFirstSubmitQcDate': '2023-10-25', 'lastUpdatePostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'up to 90 days', 'description': 'Type and severity of complications graded by Clavien-Dindo scoring system (from 0 to 5, higher scores mean worse outcome)'}, {'measure': 'Survival', 'timeFrame': 'Overall survival from surgery to death or last follow up, whichever came first, assessed up to 60 months', 'description': 'Overall survival'}], 'secondaryOutcomes': [{'measure': 'Rate of reoperations', 'timeFrame': 'up to 90 days', 'description': 'Reoperations'}, {'measure': 'Length of postoperative hospital stay', 'timeFrame': 'Up to 6 months', 'description': 'Hospital stay'}, {'measure': 'Rate of readmissions', 'timeFrame': 'One year from surgery', 'description': 'Readmission'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['gastric cancer', 'locally advanced cancers', 'multivisceral resections', 'splenectomy', 'pancreatectomy', 'colectomy'], 'conditions': ['Gastric Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to assess whether the postoperative course and survival of patients subject to multivisceral resections for locally advanced gastric cancer (cT4b) were affected by the extent of surgery. An electronic database of 1476 patients with non-metastatic gastric cancer treated between January 1996 and December 2020 will be reviewed. The main questions it aims to answer are:\n\n* Does splenectomy, distal pancreatectomy or partial colectomy affect postoperative complications\n* What factors affect prognosis of patients with locally advanced gastric cancer'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with resectable gastric cancer treated between January 1996 and December 2020 in the First Department of Surgery, Jagiellonian University Medical College', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gastric adenocarcinoma\n* intraoperatively suspected infiltration of surrounding organs (stage cT4bN0-3bM0)\n* partial or total gastrectomy\n\nExclusion Criteria:\n\n* distant metastases (M1)\n* gastrectomy combined with resection of organs other than spleen, pancreas, or colon'}, 'identificationModule': {'nctId': 'NCT06103435', 'acronym': 'TOCCATA', 'briefTitle': 'Multivisceral Resections for Locally Advanced Gastric Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Multivisceral Resections for Locally Advanced Gastric Cancer', 'orgStudyIdInfo': {'id': 'GC_MVR'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Extent od surgical resection', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '30-688', 'city': 'Krakow', 'state': 'Małopolska', 'country': 'Poland', 'facility': 'First Department of Surgery, Jagiellonian University Medical College', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Marek Sierżęga, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jagiellonian University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Marek Sierzega', 'investigatorAffiliation': 'Jagiellonian University'}}}}