Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-27 @ 1:44 AM
Study NCT ID:
NCT05255393
Status:
COMPLETED
Last Update Posted:
2025-11-21
First Post:
2022-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survey on Lymphedema After Sentinel Lymph Node Biopsy in People With Cervical or Vulvar Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical Neoplasms'}, {'id': 'D014846', 'term': 'Vulvar 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': 'D002577', 'term': 'Uterine Cervical Diseases'}, {'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': 'D014845', 'term': 'Vulvar 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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2025-11-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2022-02-16', 'studyFirstSubmitQcDate': '2022-02-16', 'lastUpdatePostDateStruct': {'date': '2025-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of patient-reported lower extremity lymphedema', 'timeFrame': '1 year', 'description': 'Prevalence will be measured using the 13-item questionnaire as reported by the patient.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Questionnaire', 'Sentinel Lymph Node Biopsy', 'Lymphedema', '22-002'], 'conditions': ['Cervical Cancer', 'Vulvar Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to collect information that may identify people who are at risk of developing lower extremity lymphedema (LEL) after sentinel lymph node biopsy (SLN) during surgery for early-stage vulvar or cervical cancer, and to improve the quality and accuracy of the information that is given to people who have this procedure.\n\nPlease note that, during this study, the researchers will collect information from a questionnaire completed by people who had SLN and LND+/- SLN during surgery for early-stage cervical or vulvar cancer. No form of treatment will be provided as part of the study, and no investigational tests or procedures will be performed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All patients in the GYN DMT's cervical cancer and vulvar cancer databases", 'genderDescription': 'Cervical or Vulvar Cancer', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presented to MSK with newly diagnosed early-stage cervical cancer of any histologic profile or early stage vulvar cancer of any histologic profile.\n\n °Early stage: Stage 1-2\n* Underwent primary surgery at our institution between January 2006 and January 2022.\n* Alive at the time of study activation\n* English comprehension\n* Capable of providing informed consent\n\nExclusion Criteria:\n\n* Had documented macroscopic evidence of metastatic disease at the time of initial diagnosis'}, 'identificationModule': {'nctId': 'NCT05255393', 'briefTitle': 'Survey on Lymphedema After Sentinel Lymph Node Biopsy in People With Cervical or Vulvar Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'RELEVANT Prevalence of Patient-Reported Lymphedema Following Surgical Management of Cervical or Vulvar Cancer', 'orgStudyIdInfo': {'id': '22-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard lymphadenectomy(LND) with sentinel lymph node mapping (SLN)', 'description': 'Patients will receive up to two mailings or messages and two phone calls if they do not respond. Self-addressed, stamped envelopes will be provided for return of questionnaires.\n\nNo other interventions are planned.', 'interventionNames': ['Other: Questionnaires']}, {'label': 'Standard lymphadenectomy(LND) alone', 'description': 'Patients will receive up to two mailings or messages and two phone calls if they do not respond. Self-addressed, stamped envelopes will be provided for return of questionnaires.\n\nNo other interventions are planned.', 'interventionNames': ['Other: Questionnaires']}], 'interventions': [{'name': 'Questionnaires', 'type': 'OTHER', 'description': 'A 13-item questionnaire specific to LEL, developed and validated by investigators at the Mayo Clinic.\n\nThe EORTC QLQ-C30 is a 30-item questionnaire designed to assess the quality of life of cancer patients.\n\nThe EORTC Quality of Life - Cervical Cancer Module.', 'armGroupLabels': ['Standard lymphadenectomy(LND) alone', 'Standard lymphadenectomy(LND) with sentinel lymph node mapping (SLN)']}]}, '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'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}