Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:12 AM
Study NCT ID:
NCT06143605
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2023-11-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}], '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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016879', 'term': 'Salvage Therapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 527}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-16', 'studyFirstSubmitDate': '2023-11-16', 'studyFirstSubmitQcDate': '2023-11-16', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'DFS', 'timeFrame': '5 year', 'description': 'disease free survival'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endoscopic resection'], 'conditions': ['Rectal Neoplasms', 'Neuroendocrine Tumors']}, 'descriptionModule': {'briefSummary': 'we evaluated all related clinical and pathologic data of rectal NET cases, including the resection margin status, NET grading, and lymphovascular invasion status. Finally, the present study was aimed at (1) determining the risk factors for LN and distant metastases in colorectal NETs (2) clarifying the clinical significance of the salvage treatment for colorectal neuroendocrine tumors following initial endoscopic resection with positive resection margin status and (3) compare different salvage treatment of this uncommon disease through conducting a large, multi-center cohort study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients with rectal neuroendocrine tumors following initial endoscopic resection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* within the age range of 18 to 65 years, diagnosed with rectal neuroendocrine tumors. Furthermore, patients were required to have a palpable tumor as determined by digital rectal examination or accessible through proctoscopy, with the distal border situated within 12 cm from the anal verge.\n\nExclusion Criteria:\n\n* (1) muscularis propria invasion or NET grading = 3, (2)regional LN or distant organs metastasis at the time of diagnosis, (3) incomplete follow-up information, (4) the patient had multiple primary tumors, (5) patients with surgical excision or inappropriate methods such as forceps removal, and (6) the patient had a history of malignant tumors.'}, 'identificationModule': {'nctId': 'NCT06143605', 'briefTitle': 'Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Clinical Relevance of the Salvage Treatment for Colorectal Neuroendocrine Tumors Based on the Pathological Evaluation Following Initial Endoscopic Resection: A Multi-center Study', 'orgStudyIdInfo': {'id': 'GIH-SYip33'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'salvage treatment group', 'description': 'patients with salvage treatment after endoscopic resection were diagnosed as having positive resection margin status', 'interventionNames': ['Procedure: salvage treatment']}, {'label': 'without salvage treatment group', 'description': 'patients without salvage treatment after endoscopic resection were diagnosed as having positive resection margin status'}], 'interventions': [{'name': 'salvage treatment', 'type': 'PROCEDURE', 'description': 'salvage radical surgery or endoscopic resection', 'armGroupLabels': ['salvage treatment group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'available upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yanhong Deng', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Yanhong Deng', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}