Ignite Creation Date:
2025-12-25 @ 12:26 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT06135558
Status:
COMPLETED
Last Update Posted:
2023-11-18
First Post:
2023-11-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Significance of Marginal Acute Inflammation for Stage II Colon Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 1167}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-11', 'studyFirstSubmitDate': '2023-11-11', 'studyFirstSubmitQcDate': '2023-11-11', 'lastUpdatePostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DFS', 'timeFrame': '5 year', 'description': 'disease free survival'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammation', 'Colon Cancer']}, 'descriptionModule': {'briefSummary': 'Marginal acute inflammation would make reporting the serosal involvement of tumors controversial. We aimed to investigate the clinical significance and explore the prognostic value of MAI for stage II localized colon cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'stage II colon cancer patients', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* (1) colon cancer patients with the preoperative staging of stage I-III who lacked distant metastasis; (2) patients who underwent radical resection, with postoperative pathology confirmed as pT3-4N0M0; and (3) complete follow-up information\n\nExclusion Criteria:\n\n* (1) patients who received neo-adjuvant therapy; (2) patients with multiple primary colorectal cancer; and (3) patients with a history of malignant tumors'}, 'identificationModule': {'nctId': 'NCT06135558', 'briefTitle': 'Clinical Significance of Marginal Acute Inflammation for Stage II Colon Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Presence and Clinical Significance of Marginal Acute Inflammation for Stage II Colon Cancer', 'orgStudyIdInfo': {'id': 'GIH-SYip32'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'T3', 'description': 'patient staged T3 without marginal acute inflammation', 'interventionNames': ['Diagnostic Test: MAI detection']}, {'label': 'MAI', 'description': 'patient with marginal acute inflammation', 'interventionNames': ['Diagnostic Test: MAI detection']}, {'label': 'T4', 'description': 'patient staged T4 without marginal acute inflammation', 'interventionNames': ['Diagnostic Test: MAI detection']}], 'interventions': [{'name': 'MAI detection', 'type': 'DIAGNOSTIC_TEST', 'description': 'to detect the presence of marginal acute inflammation', 'armGroupLabels': ['MAI', 'T3', 'T4']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Yanhong Deng', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}