Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-02-25 @ 6:42 PM
Study NCT ID:
NCT02822833
Status:
UNKNOWN
Last Update Posted:
2016-09-13
First Post:
2016-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Indocyanine Green to Identify Sentinel Lymph Node in Uterine 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007208', 'term': 'Indocyanine Green'}], 'ancestors': [{'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-09-11', 'studyFirstSubmitDate': '2016-06-24', 'studyFirstSubmitQcDate': '2016-07-01', 'lastUpdatePostDateStruct': {'date': '2016-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of sentinel lymph node frozen section', 'timeFrame': '6 months'}, {'measure': 'Unilateral or bilateral sentinel lymph node detection rate by indocyanine green', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Negative and positive predictive values for sentinel lymph node frozen section', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Endometrial Neoplasm']}, 'descriptionModule': {'briefSummary': "Endometrial cancer is the most common gynecologic malignancy in developed countries and the second one in developing countries following cervical cancer. The primary treatment for endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy, with adjuvant radiotherapy and/or chemotherapy reserved for patients with advanced disease or who have risk factors for relapse. The tumor is confined to the uterus in 85% of endometrial cancers. Hence, it's controversial to perform systematic lymphadenectomy to all patients. The primary purpose of the present study is the to investigate the feasibility of sentinel lymph node determination in endometrial cancer patients operated via conventional laparoscopy. To determine sentinel lymph nodes cervical indocyanine green will be injected prior to the surgery. During the surgery using fluorescent imaging systems sentinel lymph nodes will be removed and examined by frozen section. Afterwards, systematic pelvic lymphadenectomy will be performed. In case of type II endometrial cancer, grade 3, metastatic sentinel lymph nodes or macroscopically enlarged paraaortic lymph nodes, paraaortic lymphadenectomy will also be performed. The secondary purpose of the study is to compare the conventional laparoscopy in sentinel lymph node mapping of endometrial cancer patients."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pathologic diagnosis of endometrial cancer\n* Clinical stage I or II\n\nExclusion Criteria:\n\n* Contraindications for operation (hematological or coagulation disorders)\n* Advanced stage\n* Pregnancy or puerperium\n* Fertility preserving surgery'}, 'identificationModule': {'nctId': 'NCT02822833', 'briefTitle': 'The Role of Indocyanine Green to Identify Sentinel Lymph Node in Uterine Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'orgStudyIdInfo': {'id': '04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sentinel lymph node mapping', 'description': 'Sentinel lymph node mapping with indocyanine green injection to cervix in endometrial cancer patients operated laparoscopically', 'interventionNames': ['Procedure: Sentinel lymph node mapping']}], 'interventions': [{'name': 'Sentinel lymph node mapping', 'type': 'PROCEDURE', 'otherNames': ['Karl Storz ICG system, to visualize the fluorescence', 'Indocyanine green, PULSION medical systems'], 'description': 'Before laparoscopic hysterectomy and lymphadenectomy procedure for endometrial cancer, Indocyanine green solution will be injected through cervix. Then the surgeon will look for sentinel lymph nodes under fluorescence visualization.', 'armGroupLabels': ['Sentinel lymph node mapping']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Salih Taşkın, Assoc. Prof.', 'role': 'CONTACT', 'email': 'salihtaskin@yahoo.com', 'phone': '+903125956405'}, {'name': 'Salih Taşkın, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Fırat Ortaç, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ankara University School of Medicine Department of Ob&Gyn', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'Salih Taşkın, Assoc. Prof.', 'role': 'CONTACT', 'email': 'salihtaskin@yahoo.com', 'phone': '+903125956405'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assoc. Prof.', 'investigatorFullName': 'salih taskin', 'investigatorAffiliation': 'Ankara University'}}}}