Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
Study NCT ID:
NCT04392895
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2020-05-13
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Para Aortic Lymphadenectomy : Always ?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002583', 'term': 'Uterine Cervical 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': '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2020-05-13', 'studyFirstSubmitQcDate': '2020-05-13', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes.', 'timeFrame': '1 day', 'description': 'negative predictive value of PET/CT on para aortic nodes when no pathological pelvic nodes.\n\nThe intraoperative 3D optical scan gives the tumor localization obtained by radioguided occult lesion localization thanks to pen marking left by the surgeon. The comparison is done by superimposing both acquisitions.'}], 'secondaryOutcomes': [{'measure': 'morbidity of PAL', 'timeFrame': '1 day', 'description': 'morbidity of PAL'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Locally advanced cervical cancer, more than IB3 stage FIGO 2018', 'Para aortic lymphadenectomy', 'Laparoscopy', 'PET/CT'], 'conditions': ['Cervical Cancer']}, 'descriptionModule': {'briefSummary': 'Cervical cancer affects more than 3000 new cases per year in France. The treatment of stage IB3 to IVA cervical cancer is based on concomitant radio-chemotherapy. The irradiation volumes are based, according to current recommendations, on imaging examinations and / or on the results of a laparoscopic Para-aortic lymphadenectomy (PAL). There is some risk of false negatif with the PET/CT. For this reason, most of the time, PAL is offered when there is no pathological paraaortic lymph node on PET/CT. The investigators suppose that this staging surgery could be avoid when no pathological pelvic nodes are identified on PET/CT. The investigators use a retrospective study, to analyse histological report of systematic PAL, comparing to results of pre-operative PET/CT.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with locally advanced cervical cancer, who had undergone a PAL after a negative paraaortic PET CT, between January 2015 and december 2019', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n\\- Patients with :\n\n* locally advanced cervical cancer,\n* who undergone PAL\n* with pre operative PET CT, between January 2015 and december 2019\n\nExclusion criteria:\n\n\\- patients aged under 18'}, 'identificationModule': {'nctId': 'NCT04392895', 'acronym': 'PALA', 'briefTitle': 'Para Aortic Lymphadenectomy : Always ?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Assesment of Paraaortic Lymphadenectomy in Locally Advanced Cervical Cancer, When no Pathologic Pelvic Lymph Node on PET/CT: Retrospective Study.', 'orgStudyIdInfo': {'id': 'RECHMPL20_0296'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with locally advanced cervical cancer', 'description': 'Patients with locally advanced cervical cancer, who had undergone a PAL', 'interventionNames': ['Procedure: Para Aortic Lymphadenectomy (PAL) by laparoscopy']}], 'interventions': [{'name': 'Para Aortic Lymphadenectomy (PAL) by laparoscopy', 'type': 'PROCEDURE', 'description': 'Para Aortic Lymphadenectomy (PAL) by laparoscopy', 'armGroupLabels': ['Patients with locally advanced cervical cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'Uhmontpellier', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Martha DURAES, Md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'NC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}