Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-01-06 @ 10:20 PM
Study NCT ID:
NCT00987051
Status:
COMPLETED
Last Update Posted:
2012-12-11
First Post:
2009-07-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sentinel Node and Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-10', 'studyFirstSubmitDate': '2009-07-30', 'studyFirstSubmitQcDate': '2009-09-29', 'lastUpdatePostDateStruct': {'date': '2012-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-09-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection and false negative rates of sentinel node', 'timeFrame': 'During the surgery (hysterectomy)'}], 'secondaryOutcomes': [{'measure': 'Morbidity and recurrence rates', 'timeFrame': 'During 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sentinel node procedure', 'radiocolloid', 'patent blue'], 'conditions': ['Endometrial Neoplasms']}, 'referencesModule': {'references': [{'pmid': '25450151', 'type': 'DERIVED', 'citation': 'Darai E, Dubernard G, Bats AS, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Ballester M. Sentinel node biopsy for the management of early stage endometrial cancer: long-term results of the SENTI-ENDO study. Gynecol Oncol. 2015 Jan;136(1):54-9. doi: 10.1016/j.ygyno.2014.09.011. Epub 2014 Oct 22.'}, {'pmid': '21489874', 'type': 'DERIVED', 'citation': 'Ballester M, Dubernard G, Lecuru F, Heitz D, Mathevet P, Marret H, Querleu D, Golfier F, Leblanc E, Rouzier R, Darai E. Detection rate and diagnostic accuracy of sentinel-node biopsy in early stage endometrial cancer: a prospective multicentre study (SENTI-ENDO). Lancet Oncol. 2011 May;12(5):469-76. doi: 10.1016/S1470-2045(11)70070-5. Epub 2011 Apr 12.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the relevance of sentinel node in endometrial cancer. Sentinel node is thought to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy.', 'detailedDescription': 'To investigate the relevance of sentinel node in endometrial cancer. Sentinel node is though to reflect the status of lymph node. Only 10 to 20% of women with endometrial cancer exhibit lymph node metastasis hence systematic lymphadenectomy is questionable. In breast cancer, melanoma and vulvar cancer, sentinel node has emerged as an alternative to complete lymphadenectomy. The objective of our trial is to validate the concept of sentinel node in endometrial cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient over 18 years old with a surgery planned for endometrial cancer\n* endometrial cancer proved by biopsy\n* early stage of endometrial cancer (FIGO stage 1-2)\n* without contraindication to surgery\n* inform consent signed\n* affiliated to general health system\n\nExclusion Criteria:\n\n* endometrial cancer FIGO stages 3-4\n* previous history of surgery modifying lymphatic drainage (conization myomectomy)\n* pregnant women or breast feeding'}, 'identificationModule': {'nctId': 'NCT00987051', 'acronym': 'Senti-Endo', 'briefTitle': 'Sentinel Node and Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Validation of the Sentinel Node in Endometrial Cancer', 'orgStudyIdInfo': {'id': 'P060229'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients with endometrial cancer', 'interventionNames': ['Procedure: Detection of sentinel node']}], 'interventions': [{'name': 'Detection of sentinel node', 'type': 'PROCEDURE', 'description': 'Coelioscopy or laparotomy (based on the tumor size) after a colorimetric tracer injection', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75020', 'city': 'Paris', 'country': 'France', 'facility': 'Tenon Hospital', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Emile DARAÏ, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}