Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:33 PM
Study NCT ID:
NCT07202169
Status:
COMPLETED
Last Update Posted:
2025-10-01
First Post:
2025-09-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Intramural Spread Pattern in Low Rectal Cancer.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2025-09-23', 'studyFirstSubmitQcDate': '2025-09-23', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the distance of intramural spread', 'timeFrame': '2023.01-2024.12'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer Patients', 'Rectal Cancer Stage']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to study the law of intramural diffusion of low rectal cancer in different stages, and to explore the relationship between intramural diffusion of low rectal cancer and the distal resection margin during operation, so as to provide theoretical basis for clinicians to formulate accurate and individualized treatment plans, and help improve the prognosis and quality of life of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ultra-low rectal cancer', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion criteria\n\n 1. Patients aged 18-75 years old\n 2. Pathology suggestive of moderately to highly differentiated rectal adenocarcinoma\n 3. Tumor lower margin ≤ 5 cm from the anal verge\n 4. No distant metastasis such as lung, liver and other organs\n* exclusion criteria\n\n 1. Preoperative patients with severe underlying diseases (such as severe liver and kidney function, cardiopulmonary function, coagulation dysfunction, etc.)\n 2. Patients with malignant tumors in other parts of the body'}, 'identificationModule': {'nctId': 'NCT07202169', 'briefTitle': 'Study of Intramural Spread Pattern in Low Rectal Cancer.', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital of Wenzhou Medical University'}, 'officialTitle': 'Pattern of the Intramural Spread of Ultralow Rectal Cancer With the Resection Margin.', 'orgStudyIdInfo': {'id': 'KY2025-R091'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with T1 ultra-low rectal cancer'}, {'label': 'Patients with T2 ultra-low rectal cancer'}, {'label': 'Patients with T3 ultra-low rectal cancer'}, {'label': 'Patients with T4 ultra-low rectal cancer'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Wenzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'The First Affiliated Hospital of Whenzhou Medical University', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'First Affiliated Hospital of Wenzhou Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}