Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2026-02-24 @ 9:56 AM
Study NCT ID:
NCT02912767
Status:
COMPLETED
Last Update Posted:
2020-06-04
First Post:
2016-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Self Reported Lymphedema in Patients With Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}, {'id': 'D008209', 'term': 'Lymphedema'}], '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'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 625}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07-20'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-06', 'completionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-01', 'studyFirstSubmitDate': '2016-09-21', 'studyFirstSubmitQcDate': '2016-09-21', 'lastUpdatePostDateStruct': {'date': '2020-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'compare lymphedema prevalence', 'timeFrame': '1 year', 'description': 'Data from respondents will be analyzed to determine prevalence of patient reported lymphedema overall; these will then be compared to the prevalence among those who underwent SLN mapping alone, or a comprehensive pelvic lymphadenectomy (+/- para-aortic LND and +/-SLN mapping in conjunction).'}]}, 'conditionsModule': {'keywords': ['lower-extremity lymphedema', '16-1001'], 'conditions': ['Endometrial Cancer', 'Lymphedema']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mskcc.org/', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The investigators are interested in understanding how the patient has been doing since their surgery for endometrial cancer and if they are experiencing any symptoms related to lymphedema (swelling) in the your lower body. The investigators hope that information from the patient and others will help them improve care for women treated for endometrial cancer.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be identified from a retrospective database maintained by the GYN DMT. Patients will be contacted by mail for the first attempt at recruitment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presented to MSK with newly diagnosed endometrial carcinoma of any histologic profile clinically confined to the uterus and/or uterine cervix\n* Underwent primary surgery at our institution, to include at least a total hysterectomy via laparotomy, laparoscopy, or robotic approach, between January 2006 and December 2013\n* Alive at the time of study activation\n\nExclusion Criteria:\n\n* Had documented macroscopic evidence of extrauterine disease at the time of initial diagnosis'}, 'identificationModule': {'nctId': 'NCT02912767', 'briefTitle': 'Prevalence of Self Reported Lymphedema in Patients With Endometrial Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Prevalence of Self Reported Lymphedema in Patients With Endometrial Cancer', 'orgStudyIdInfo': {'id': '16-1001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SLN cohort', 'description': 'Patients who underwent hysterectomy only or with SLN mapping alone.', 'interventionNames': ['Behavioral: questionnaire']}, {'label': 'LND cohort', 'description': 'Patients who underwent hysterectomy with standard lymphadenectomy, with or without SLN mapping.', 'interventionNames': ['Behavioral: questionnaire']}], 'interventions': [{'name': 'questionnaire', 'type': 'BEHAVIORAL', 'description': 'A questionnaire that has been validated by investigators at the Mayo Clinic. The questionnaire has 13 items to assess the rate of patient-reported lymphedema. The questionnaire will be mailed and then followed up with a second mailing after month 1 and a phone call after month 2. Within 3 months of sending the questionnaire a patient will be either considered as a responder vs non-responder. The date of surgery and the date of when the questionnaire is filled out will be captured.', 'armGroupLabels': ['LND cohort', 'SLN cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Mario Leitao, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}