Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-05 @ 6:28 PM
Study NCT ID:
NCT03900104
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2019-03-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cervical and Endometrial Injection for Sentinel Lymph Node Detection in 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2019-03-31', 'studyFirstSubmitQcDate': '2019-03-31', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detected pelvic and paraaortic sentinel lymph node numbers', 'timeFrame': 'Postoperative 30 days', 'description': 'Detected pelvic and paraaortic sentinel lymph node numbers in pathological examination (Ultrastaging)'}], 'secondaryOutcomes': [{'measure': 'Numbers adverse events', 'timeFrame': 'Postoperative 90 days', 'description': 'Number of adverse events associated with the surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endometrial Cancer', 'Sentinel Lymph Node', 'Paraaortic nodes involvement'], 'conditions': ['Endometrial Cancer', 'Sentinel Lymph Node']}, 'referencesModule': {'references': [{'pmid': '22659192', 'type': 'BACKGROUND', 'citation': 'Solima E, Martinelli F, Ditto A, Maccauro M, Carcangiu M, Mariani L, Kusamura S, Fontanelli R, Grijuela B, Raspagliesi F. Diagnostic accuracy of sentinel node in endometrial cancer by using hysteroscopic injection of radiolabeled tracer. Gynecol Oncol. 2012 Sep;126(3):419-23. doi: 10.1016/j.ygyno.2012.05.025. Epub 2012 May 30.'}, {'pmid': '23988415', 'type': 'BACKGROUND', 'citation': 'Niikura H, Kaiho-Sakuma M, Tokunaga H, Toyoshima M, Utsunomiya H, Nagase S, Takano T, Watanabe M, Ito K, Yaegashi N. Tracer injection sites and combinations for sentinel lymph node detection in patients with endometrial cancer. Gynecol Oncol. 2013 Nov;131(2):299-303. doi: 10.1016/j.ygyno.2013.08.018. Epub 2013 Aug 27.'}]}, 'descriptionModule': {'briefSummary': 'The investigators think that trans-cervical endometrial tracer injection will cause more paraaortic sentinel lymph node detection. Also, this application is easy, cost-effective and safer than hysteroscopic method. Transtubal tumor spearing will not occur with this method.', 'detailedDescription': 'Endometrial tracer injection will be performed by cervical or transcervical endometrial methods. Pelvic and para-aortic sentinel lymph node detection capacity will be assessed in this study.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Endometrial Cancer Patients\n* Suitable patients for surgical staging\n\nExclusion Criteria:\n\n* Patients who cannot undergo cervical or transcervical endometrial injection\n* Pathology did not confirm endometrial cancer\n* Sarcoma of the uterine corpus\n* If a 90-day follow-up was not feasible'}, 'identificationModule': {'nctId': 'NCT03900104', 'briefTitle': 'Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Cervical and Endometrial Injection for Sentinel Lymph Node Detection in Endometrial Cancer: A Prospective Randomized Trial', 'orgStudyIdInfo': {'id': 'CEIN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transcervical endometrial injection arm', 'description': 'Tracer injection performed by a transcervical catheter in endometrial cancer patients.', 'interventionNames': ['Procedure: Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cervical injection arm', 'description': 'Tracer injection was administered via the cervical route in endometrial cancer patients.', 'interventionNames': ['Procedure: Cervical injection of technetium 99 m-labeled human albumin colloid particles']}], 'interventions': [{'name': 'Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles', 'type': 'PROCEDURE', 'description': 'Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery. Injection performed with a trans-cervical catheter', 'armGroupLabels': ['Transcervical endometrial injection arm']}, {'name': 'Cervical injection of technetium 99 m-labeled human albumin colloid particles', 'type': 'PROCEDURE', 'description': 'Cervical injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery.', 'armGroupLabels': ['Cervical injection arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41380', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'Şener Gezer, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kocaeli University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Şener Gezer', 'investigatorAffiliation': 'Kocaeli University'}}}}