Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT05572151
Status:
COMPLETED
Last Update Posted:
2022-10-07
First Post:
2022-10-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Determining the Optimal Examined Lymph Node for Accurate Staging and Long-term Survival in Rectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012004', 'term': 'Rectal 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': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7694}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-06', 'studyFirstSubmitDate': '2022-10-04', 'studyFirstSubmitQcDate': '2022-10-06', 'lastUpdatePostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-10-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'lymph node number', 'timeFrame': 'during the surgery', 'description': 'lymph nodes were harvested during surgical resection of rectal cancer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Rectal Cancer']}, 'referencesModule': {'references': [{'pmid': '28542954', 'type': 'BACKGROUND', 'citation': 'Del Paggio JC, Peng Y, Wei X, Nanji S, MacDonald PH, Krishnan Nair C, Booth CM. Population-based study to re-evaluate optimal lymph node yield in colonic cancer. Br J Surg. 2017 Jul;104(8):1087-1096. doi: 10.1002/bjs.10540. Epub 2017 May 24.'}, {'pmid': '37428195', 'type': 'DERIVED', 'citation': 'Guan X, Jiao S, Wen R, Yu G, Liu J, Miao D, Wei R, Zhang W, Hao L, Zhou L, Lou Z, Liu S, Zhao E, Wang G, Zhang W, Wang X. Optimal examined lymph node number for accurate staging and long-term survival in rectal cancer: a population-based study. Int J Surg. 2023 Aug 1;109(8):2241-2248. doi: 10.1097/JS9.0000000000000320.'}]}, 'descriptionModule': {'briefSummary': 'A multi-institutional registry of collected data on patients with rectal cancer who underwent surgical resection between January 2009 and December 2018 at the departments of colorectal surgery of five medical institutions in China', 'detailedDescription': 'A multi-institutional registry of collected data on patients with rectal cancer who underwent surgical resection between January 2009 and December 2018 at the departments of colorectal surgery of five medical institutions in China (National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College; Changhai Hospital, Naval Medical University; The Second Affiliated Hospital of Harbin Medical University; The Affiliated Tumor Hospital of Harbin Medical University; The Affiliated Tumor Hospital of Guangxi Medical University)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Information about patients (age, sex and year of diagnosis), tumor (TNM stages, histology, size and differentiation), treatments (resection type, chemotherapy), and outcome variables (follow-up time and survival status) were obtained in SEER database and China registry', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Rectal cancer patients in stage I-III who underwent surgical resection for first primary rectal cancer with at least one lymph node were eligible\n\nExclusion Criteria:\n\n* Patients with missing values on lymph node count and clinical features were excluded'}, 'identificationModule': {'nctId': 'NCT05572151', 'briefTitle': 'Determining the Optimal Examined Lymph Node for Accurate Staging and Long-term Survival in Rectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'The Second Affiliated Hospital of Harbin Medical University'}, 'officialTitle': 'Determining the Optimal Examined Lymph Node for Accurate Staging and Long-term Survival in Rectal Cancer: a Population Study of the US Database and a Chinese Multi-institutional Registry', 'orgStudyIdInfo': {'id': '82100598'}}, 'armsInterventionsModule': {'interventions': [{'name': 'lymph node number', 'type': 'PROCEDURE', 'description': 'Lymph nodes were harvested during surgical resection of rectal cancer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Affiliated Hospital of Harbin Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Shuai Jiao', 'investigatorAffiliation': 'The Second Affiliated Hospital of Harbin Medical University'}}}}