Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2026-03-09 @ 8:56 PM
Study NCT ID:
NCT03794193
Status:
UNKNOWN
Last Update Posted:
2022-05-04
First Post:
2018-09-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004358', 'term': 'Drug Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1367}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2016-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-28', 'studyFirstSubmitDate': '2018-09-09', 'studyFirstSubmitQcDate': '2019-01-03', 'lastUpdatePostDateStruct': {'date': '2022-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '3-year Disease-free Survival', 'timeFrame': 'Within 3 years after surgery', 'description': 'The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis, with the most recent recurrence and metastasis.'}], 'secondaryOutcomes': [{'measure': '3-year Over-all Survival', 'timeFrame': 'Within 3 years after surgery', 'description': 'The time from the time of surgery to the time of recurrence or death from any cause, calculated on a monthly basis.'}, {'measure': 'Postoperative complication rate', 'timeFrame': 'Within 30 days after surgery'}, {'measure': 'Postoperative mortality rate', 'timeFrame': 'Within 30 days after surgery'}, {'measure': 'Local recurrence rate', 'timeFrame': 'Within 3 years after surgery'}, {'measure': 'Distant organ metastasis rate', 'timeFrame': 'Within 3 years after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colon Cancer']}, 'referencesModule': {'references': [{'pmid': '37718392', 'type': 'DERIVED', 'citation': 'Li K, Zhao F, Guo Y, Wu Q, Luo S, Zhang J, Li H, Hu S, Wu B, Lin G, Qiu H, Niu B, Sun X, Xu L, Lu J, Du X, Wang Z, Wang X, Kang L, Wang Z, Wang Q, Liu Q, Xiao Y. Interaction analysis of high-risk pathological features on adjuvant chemotherapy survival benefit in stage II colon cancer patients: a multi-center, retrospective study. BMC Cancer. 2023 Sep 18;23(1):797. doi: 10.1186/s12885-023-11196-4.'}]}, 'descriptionModule': {'briefSummary': 'To explore the effect of unfavorable histological features on the clinical outcomes of patients receiving radical resection of colon cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Colon cancer patients with or without unfavorable histological features', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age: 18-100 years old;\n2. Postoperative pathology confirmed colon adenocarcinoma;\n3. The tumor is located from the cecum to the sigmoid colon;\n4. No distant organ metastasis;\n\nExclusion Criteria:\n\n1. Simultaneous or metachronous multiple primary colorectal cancer;\n2. History of previous malignant tumors (except for completely cured cervical carcinoma in situ or basal cell carcinoma or squamous epithelial skin cancer)\n3. local excision procedure;\n4. palliative resection (R2 resection);\n5. pregnant or lactating women.'}, 'identificationModule': {'nctId': 'NCT03794193', 'briefTitle': 'The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'The Effect of Unfavorable Histological Features on the Oncological Outcomes of Colon Cancer', 'orgStudyIdInfo': {'id': 'ZS-1653'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Radical resection of colon cancer', 'type': 'PROCEDURE', 'otherNames': ['Chemotherapy'], 'description': 'The patients with colon cancer will receive radical surgery. Adjuvant chemotherapy will be given according to the results of postoperative histological results.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yi Xiao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Individual participant data can be shared with all researchers involved in the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}, {'name': 'West China Hospital', 'class': 'OTHER'}, {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, {'name': 'Peking University First Hospital', 'class': 'OTHER'}, {'name': 'Union Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}