Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2025-12-24 @ 1:53 PM
Study NCT ID:
NCT04334395
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2020-04-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Retrospective Cohort Study Outcome of Treatment in Asymptomatic Stage 4 Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'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': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-02', 'studyFirstSubmitDate': '2020-04-02', 'studyFirstSubmitQcDate': '2020-04-02', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complication rate', 'timeFrame': '5 year', 'description': 'The definition of complication defined as symptom that occurred during treatment period such as obstruction , perforation , bleeding , trenesmus.'}], 'secondaryOutcomes': [{'measure': 'The survival time', 'timeFrame': '5 year', 'description': 'The survival time defined as time from diagnosis to death or last follow up period'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stage IV Colon Cancer']}, 'descriptionModule': {'briefSummary': 'In asymptomatic Stage 4 colorectal cancer, the treatment varies between many hospitals and countries. Some studies found that primary tumor resection had better survival rates and a lower risk of mortality. But many studies found significant benefits in survival in sub groups of the population such as age less than 70 years, WHO performance status \\<2, no extra-hepatic metastasis, liver tumor burden \\<50%. However some studies showed no survival benefits in primary tumor resection. So this study will focus on survival, adverse events, complications in primary tumor resection and no primary tumor resection in asymptomatic Stage 4 colorectal cancer.', 'detailedDescription': 'The retrospective study of patients in asymptomatic Stage 4 colorectal cancer received treatment at Ramathibodi Hospital and excluded symptomatic primary tumors such as obstruction, perforation that required surgery, carcinomatosis peritoneii, and patients with secondary cancer diagnosis in the past 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Medical records of stage IV colorectal cancer with unresectable distant metastasis received treatment in Ramathibodi hospital between 1 September 2006 - 31 August 2016.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asymptomatic stage IV colorectal cancer\n* pathological prove adenocarcinoma\n* age \\>18 years\n* no primary tumor related symptom\n* ECOG performance status \\<2\n\nExclusion Criteria:\n\n* symptomatic primary tumor such as obstruction , perforation that required surgery\n* carcinomatosis peritoneii\n* patients with secondary cancer diagnosis in 5 years'}, 'identificationModule': {'nctId': 'NCT04334395', 'briefTitle': 'A Retrospective Cohort Study Outcome of Treatment in Asymptomatic Stage 4 Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'A Retrospective Cohort Study Outcome of Treatment in Asymptomatic Stage 4 Colorectal Cancer : Primary Tumor Resection vs. No Primary Tumor Resection', 'orgStudyIdInfo': {'id': 'MURA2016/546'}}, 'armsInterventionsModule': {'interventions': [{'name': 'primary tumor resection group', 'type': 'PROCEDURE', 'description': 'resection of cancer at colon'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'state': 'Bankok', 'country': 'Thailand', 'facility': 'Chairat Supsamutchai', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Chairat Supsamutchai, MD', 'role': 'STUDY_CHAIR', 'affiliation': '270, Rama VI road, Ratchathevi, Deapartment of Surgery, Faculty of Medicine, Ramathibodi Hospital, Mahidol University, Bangkok, Thailand, 10400'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}