Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-28 @ 12:00 PM
Study NCT ID:
NCT05005650
Status:
COMPLETED
Last Update Posted:
2023-06-26
First Post:
2021-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D008207', 'term': 'Lymphatic Metastasis'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal 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': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065426', 'term': 'Cytoreduction Surgical Procedures'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 121}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2021-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-23', 'studyFirstSubmitDate': '2021-08-06', 'studyFirstSubmitQcDate': '2021-08-10', 'lastUpdatePostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Progression-free survival', 'timeFrame': 'From date of treatment until the date of first documented progression or date of death (by any cause, in the absence of disease progression) whichever came first, assessed up to 120 months', 'description': 'the time interval from the treatment start date to disease recurrence or progression date'}], 'secondaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'From the date of treatment start date until death due to any cause, assessed up to 120 months', 'description': 'the time interval from the treatment start date to death or end of study date'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['internal mammary lymph node', 'supraclavicular lymph node', 'cardiophrenic lymph node'], 'conditions': ['Ovarian Cancer Stage IV', 'Lymph Node Metastases']}, 'referencesModule': {'references': [{'pmid': '27016223', 'type': 'BACKGROUND', 'citation': 'Randall LM, Pothuri B. The genetic prediction of risk for gynecologic cancers. Gynecol Oncol. 2016 Apr;141(1):10-6. doi: 10.1016/j.ygyno.2016.03.007.'}, {'pmid': '26691222', 'type': 'BACKGROUND', 'citation': 'Ataseven B, Grimm C, Harter P, Heitz F, Traut A, Prader S, du Bois A. Prognostic impact of debulking surgery and residual tumor in patients with epithelial ovarian cancer FIGO stage IV. Gynecol Oncol. 2016 Feb;140(2):215-20. doi: 10.1016/j.ygyno.2015.12.007. Epub 2015 Dec 12.'}, {'pmid': '19408045', 'type': 'BACKGROUND', 'citation': 'Lim MC, Lee HS, Jung DC, Choi JY, Seo SS, Park SY. Pathological diagnosis and cytoreduction of cardiophrenic lymph node and pleural metastasis in ovarian cancer patients using video-assisted thoracic surgery. Ann Surg Oncol. 2009 Jul;16(7):1990-6. doi: 10.1245/s10434-009-0486-5. Epub 2009 Apr 30.'}, {'pmid': '23290988', 'type': 'BACKGROUND', 'citation': 'Yoo HJ, Lim MC, Song YJ, Jung YS, Kim SH, Yoo CW, Park SY. Transabdominal cardiophrenic lymph node dissection (CPLND) via incised diaphragm replace conventional video-assisted thoracic surgery for cytoreductive surgery in advanced ovarian cancer. Gynecol Oncol. 2013 May;129(2):341-5. doi: 10.1016/j.ygyno.2012.12.023. Epub 2013 Jan 3.'}, {'pmid': '37637060', 'type': 'DERIVED', 'citation': 'Park SJ, Na KJ, Lee M, Park IK, Chung HH, Kang CH, Kim JW, Park NH, Kim YT, Song YS, Park S, Kim HS. Impact of supradiaphragmatic lymphadenectomy on the survival of patients in stage IVB ovarian cancer with thoracic lymph node metastasis. Front Oncol. 2023 Aug 10;13:1203127. doi: 10.3389/fonc.2023.1203127. eCollection 2023.'}]}, 'descriptionModule': {'briefSummary': 'To evaluate the survival impact of extensive lymphadenectomy as part of debulking surgery in stage IVB ovarian cancer with supradiaphragmatic lymph node metastasis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients underwent treatment at University Hospital.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically diagnosed ovarian, fallopian tubal, primary peritoneal cancer\n* Patients suspected of metastatic lymph nodes in the cardiophrenic, internal mammary, and/or supraclavicular lymph node by CT (size larger than 5mm)\n* Patients clinically diagnosed FIGO stage IVB ovarian, fallopian tubal, primary peritoneal cancer\n* Patients underwent debulking surgery (primary debulking surgery or interval debulking surgery) at Seoul National University Hospital from January 2010 to January 2020\n* Patients age 18-90\n\nExclusion Criteria:\n\n* Borderline or benign ovarian disease\n* Patient didn't undergo debulking surgery\n* Non-epithelial ovarian cancer"}, 'identificationModule': {'nctId': 'NCT05005650', 'acronym': 'SDLNOC', 'briefTitle': 'Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Survival Impact of Internal Mammary or Supraclavicular Lymphadenectomy on Stage IVB Ovarian Cancer With Supradiaphragmatic Lymph Node Metastasis', 'orgStudyIdInfo': {'id': 'SDLNOC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'debulking surgery', 'type': 'PROCEDURE', 'description': 'debulking surgery as primary debulking surgery or interval debulking surgery'}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': '시/도/주', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Hee Seung Kim, Pf', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Hee Seung Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}