Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2026-01-13 @ 9:04 AM
Study NCT ID:
NCT01939028
Status:
TERMINATED
Last Update Posted:
2020-08-27
First Post:
2013-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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': 'D021701', 'term': 'Sentinel Lymph Node Biopsy'}, {'id': 'C025484', 'term': 'iso-sulfan blue'}, {'id': 'D007208', 'term': 'Indocyanine Green'}, {'id': 'D008197', 'term': 'Lymph Node Excision'}], 'ancestors': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michenc@ccf.org', 'phone': '216-444-6601', 'title': 'Dr. Chad Michener', 'organization': 'University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 30 days from last treatment dose', 'eventGroups': [{'id': 'EG000', 'title': 'Diagnostic (SLN Mapping, Biopsy, Surgery)', 'description': 'Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 1, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'New onset atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE v4.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity of Sentential Lymph Node (SLN) Biopsy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (SLN Mapping, Biopsy, Surgery)', 'description': 'Participants undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 weeks', 'description': 'Sensitivity estimated as the proportion of true positives among participants with lymph node metastases. Sensitivity Calculation= the number of patients with a positive SLN over those patients with a positive SLN plus those patients with a false negative lymph node.', 'unitOfMeasure': 'percent', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with with lymph node metastases'}, {'type': 'PRIMARY', 'title': 'Number of Participants in Whom a SLN is Detected', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (SLN Mapping, Biopsy, Surgery)', 'description': 'Participants undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.'}], 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 4 weeks', 'description': 'Detection Rate as defined by number of participants in whom a SLN is detected', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed study'}, {'type': 'PRIMARY', 'title': 'Percent of Hemipelvises Identified With SLN', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (SLN Mapping, Biopsy, Surgery)', 'description': 'Participants undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.'}], 'classes': [{'categories': [{'measurements': [{'value': '81.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 weeks', 'description': 'Detection rate, as defined by percent of hemipelvises identified with SLN', 'unitOfMeasure': 'Percent of Hemipelvises', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed study'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Sentinel Nodes Per Side of Pelvis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (SLN Mapping, Biopsy, Surgery)', 'description': 'Participants undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.'}], 'classes': [{'title': 'Right side of pelvis', 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Left side of pelvis', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 weeks', 'description': 'Detection rate, as defined as number of participants with a sentinel node found per side of pelvis', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed study'}, {'type': 'PRIMARY', 'title': 'False Negative Rate as Defined as Proportion of Participants With False Negative Detection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (SLN Mapping, Biopsy, Surgery)', 'description': 'Participants undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 weeks', 'description': 'False negative rate = 1-sensitivity or the number of patients with a false negative SLN over the number of patients with a positive SLN plus those with a false negative lymph node', 'unitOfMeasure': 'Proportion of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed study'}, {'type': 'PRIMARY', 'title': 'Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (SLN Mapping, Biopsy, Surgery)', 'description': 'Participants undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.'}], 'classes': [{'title': 'Laparoscopy', 'categories': [{'measurements': [{'value': '83.3', 'groupId': 'OG000'}]}]}, {'title': 'Robot', 'categories': [{'measurements': [{'value': '86.4', 'groupId': 'OG000'}]}]}, {'title': 'Single port', 'categories': [{'measurements': [{'value': '79.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 weeks', 'description': 'The percent of true positive SLN identified with surgical modalities using pairwise comparisons for each surgical modality. Comparisons will be performed using two sample tests of proportions based on a normal approximation.', 'unitOfMeasure': 'percentage of true positive SNLs', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed study'}, {'type': 'SECONDARY', 'title': 'Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (SLN Mapping, Biopsy, Surgery)', 'description': 'Participants undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.'}], 'classes': [{'title': 'indocyanine green', 'categories': [{'measurements': [{'value': '86.54', 'groupId': 'OG000'}]}]}, {'title': 'Blue dye', 'categories': [{'measurements': [{'value': '75', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 4 weeks', 'description': 'Percent of true positive SLN identified will be compared between injectants utilized using a two sample test of proportions based on a normal approximation. Comparisons will be performed using two sample tests of proportions based on a normal approximation.', 'unitOfMeasure': 'Percentage of true positive SLNs', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed study'}, {'type': 'SECONDARY', 'title': 'Total Operating Room Time in Minutes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diagnostic (SLN Mapping, Biopsy, Surgery)', 'description': 'Participants undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.'}], 'classes': [{'categories': [{'measurements': [{'value': '158.5', 'groupId': 'OG000', 'lowerLimit': '138.91', 'upperLimit': '178.09'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From the time the patient enters the room to the time the patient leaves the room, assessed up to 4 weeks', 'description': 'Total operating room time will be estimated as a mean with 95% confidence interval if the data have an approximately normal distribution. Otherwise, the median and a bootstrapped 95% confidence interval for the median will be reported. Similar summaries will be provided for the console time (robotic)/ operating time.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diagnostic (SLN Mapping, Biopsy, Surgery)', 'description': 'Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.\n\nlymph node mapping: Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution\n\nsentinel lymph node biopsy: Undergo SLN biopsy\n\nisosulfan blue: Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution\n\nindocyanine green solution: Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution\n\ntherapeutic conventional surgery: Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy\n\nlymphadenectomy: Undergo para-aortic lymphadenectomy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '58'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Diagnostic (SLN Mapping, Biopsy, Surgery)', 'description': 'Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '20-29 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': '30-39 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '40-49 years', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': '50-59 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': '60-69 years', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': '70-79 years', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': '80-89 years', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '46', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '42', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Evaluable participants who completed study'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2013-08-02', 'size': 295795, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-07-07T12:51', 'hasProtocol': True}, {'date': '2016-06-21', 'size': 313162, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-07-22T16:44', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'whyStopped': 'Slow Accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-26', 'studyFirstSubmitDate': '2013-07-10', 'resultsFirstSubmitDate': '2020-07-30', 'studyFirstSubmitQcDate': '2013-09-05', 'lastUpdatePostDateStruct': {'date': '2020-08-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-07-30', 'studyFirstPostDateStruct': {'date': '2013-09-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity of Sentential Lymph Node (SLN) Biopsy', 'timeFrame': 'Up to 4 weeks', 'description': 'Sensitivity estimated as the proportion of true positives among participants with lymph node metastases. Sensitivity Calculation= the number of patients with a positive SLN over those patients with a positive SLN plus those patients with a false negative lymph node.'}, {'measure': 'Number of Participants in Whom a SLN is Detected', 'timeFrame': 'Up to 4 weeks', 'description': 'Detection Rate as defined by number of participants in whom a SLN is detected'}, {'measure': 'Percent of Hemipelvises Identified With SLN', 'timeFrame': 'Up to 4 weeks', 'description': 'Detection rate, as defined by percent of hemipelvises identified with SLN'}, {'measure': 'Number of Participants With Sentinel Nodes Per Side of Pelvis', 'timeFrame': 'Up to 4 weeks', 'description': 'Detection rate, as defined as number of participants with a sentinel node found per side of pelvis'}, {'measure': 'False Negative Rate as Defined as Proportion of Participants With False Negative Detection', 'timeFrame': 'Up to 4 weeks', 'description': 'False negative rate = 1-sensitivity or the number of patients with a false negative SLN over the number of patients with a positive SLN plus those with a false negative lymph node'}, {'measure': 'Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology)', 'timeFrame': 'Up to 4 weeks', 'description': 'The percent of true positive SLN identified with surgical modalities using pairwise comparisons for each surgical modality. Comparisons will be performed using two sample tests of proportions based on a normal approximation.'}], 'secondaryOutcomes': [{'measure': 'Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution', 'timeFrame': 'Up to 4 weeks', 'description': 'Percent of true positive SLN identified will be compared between injectants utilized using a two sample test of proportions based on a normal approximation. Comparisons will be performed using two sample tests of proportions based on a normal approximation.'}, {'measure': 'Total Operating Room Time in Minutes', 'timeFrame': 'From the time the patient enters the room to the time the patient leaves the room, assessed up to 4 weeks', 'description': 'Total operating room time will be estimated as a mean with 95% confidence interval if the data have an approximately normal distribution. Otherwise, the median and a bootstrapped 95% confidence interval for the median will be reported. Similar summaries will be provided for the console time (robotic)/ operating time.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Stage I Endometrial Carcinoma', 'Stage II Endometrial Carcinoma', 'Stage III Endometrial Carcinoma', 'Stage IV Endometrial Carcinoma']}, 'descriptionModule': {'briefSummary': 'This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine the detection rate, sensitivity, and negative predictive value of sentinel lymph node (SLN) biopsy in endometrial cancer patients.\n\nSECONDARY OBJECTIVES:\n\nI. To compare different surgical modalities (open procedures, minimally invasive procedures, and single-site technology) and different injectants (isosulfan blue and indocyanine green) for SLN biopsy.\n\nII. To determine total operating room time (from the time the patient enters the room to the time the patient leaves the room) as well as console time (robotic)/operating time for minimally invasive procedures.\n\nOUTLINE:\n\nPatients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.\n\nAfter completion of study treatment, patients are followed up at 2-4 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women must have newly diagnosed histologically or cytologically confirmed endometrial cancer\n* Women should have received no prior therapy for their disease\n* Women who are planning to undergo hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy for the management of their endometrial cancer\n* Women must have the ability to understand and the willingness to sign a written informed consent document\n\nExclusion Criteria:\n\n* Women who are receiving any other investigational agents\n* Women with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to isosulfan blue or indocyanine green or other agents used in this study\n* Women with hypersensitivity to phenylmethane compounds, or a history of allergic reaction to iodides\n* Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Women with a history of prior loop electrosurgical excision procedure (LEEP) or cone procedures performed on their cervix\n* Women with a history of lymphedema, lymphoma, or lymphatic hyperplasia (Castleman disease)\n* Women with a history of a prior malignancy\n* Women may also be excluded at the discretion of their surgeon if he or she feels that the patient is not an appropriate candidate'}, 'identificationModule': {'nctId': 'NCT01939028', 'briefTitle': 'Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Sentinel Lymph Node Mapping for Endometrial Cancer', 'orgStudyIdInfo': {'id': 'CASE9813'}, 'secondaryIdInfos': [{'id': 'NCI-2013-01309', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (SLN mapping, biopsy, surgery)', 'description': 'Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy.', 'interventionNames': ['Procedure: lymph node mapping', 'Procedure: sentinel lymph node biopsy', 'Drug: isosulfan blue', 'Drug: indocyanine green solution', 'Procedure: therapeutic conventional surgery', 'Procedure: lymphadenectomy']}], 'interventions': [{'name': 'lymph node mapping', 'type': 'PROCEDURE', 'description': 'Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution', 'armGroupLabels': ['Diagnostic (SLN mapping, biopsy, surgery)']}, {'name': 'sentinel lymph node biopsy', 'type': 'PROCEDURE', 'otherNames': ['sentinel node biopsy'], 'description': 'Undergo SLN biopsy', 'armGroupLabels': ['Diagnostic (SLN mapping, biopsy, surgery)']}, {'name': 'isosulfan blue', 'type': 'DRUG', 'otherNames': ['Lymphazurin', 'N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide'], 'description': 'Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution', 'armGroupLabels': ['Diagnostic (SLN mapping, biopsy, surgery)']}, {'name': 'indocyanine green solution', 'type': 'DRUG', 'otherNames': ['IC-GREEN', 'ICG solution'], 'description': 'Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution', 'armGroupLabels': ['Diagnostic (SLN mapping, biopsy, surgery)']}, {'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE', 'description': 'Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy', 'armGroupLabels': ['Diagnostic (SLN mapping, biopsy, surgery)']}, {'name': 'lymphadenectomy', 'type': 'PROCEDURE', 'description': 'Undergo para-aortic lymphadenectomy', 'armGroupLabels': ['Diagnostic (SLN mapping, biopsy, surgery)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Chad Michener, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}