Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2025-12-30 @ 1:18 PM
Study NCT ID:
NCT06101732
Status:
COMPLETED
Last Update Posted:
2023-10-27
First Post:
2023-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LIMBO : Breast Reconstruction by Lipomodeling Alone or With Flap: Evaluation in Franche-Comté
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 140}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2023-10-17', 'studyFirstSubmitQcDate': '2023-10-20', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of surgical procedures according to the type of breast reconstruction using lipomodelling alone or in combination with a flap', 'timeFrame': 'Between october 2017 and 2022', 'description': 'number of surgical procedures'}], 'secondaryOutcomes': [{'measure': "description of patients' age", 'timeFrame': 'at inclusion', 'description': 'patient age'}, {'measure': "description of patients' Body Mass Index", 'timeFrame': 'at inclusion', 'description': 'Body Mass Index'}, {'measure': "description of patients' menopause status", 'timeFrame': 'at the time of data collection', 'description': 'menopause status'}, {'measure': "description of patients' smoking status", 'timeFrame': 'at inclusion', 'description': 'smoking status'}, {'measure': "description of patients' diabetes or other medical condition", 'timeFrame': 'at inclusion'}, {'measure': "description of patients' relevant medical history", 'timeFrame': 'at inclusion', 'description': 'relevant medical history'}, {'measure': "description of patients' History of breast surgery", 'timeFrame': 'at inclusion', 'description': 'hsitory of breast surgery'}, {'measure': "description of patients' type of cancer", 'timeFrame': 'at inclusion', 'description': 'cancer histology'}, {'measure': "description of patients' type of surgical treatment", 'timeFrame': 'at inclusion', 'description': 'type of breast reconstruction using lipomodelling alone or in combination with a flap'}, {'measure': "description of patients' Type of treatment associated with surgery", 'timeFrame': 'at inclusion', 'description': 'Type of treatment associated with surgery'}, {'measure': 'description of Time elapsed between mastectomy and reconstruction', 'timeFrame': 'at inclusion', 'description': 'number of month between the date of mastectomy and date of reconstruction'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['lipodelling', 'breast reconstruction'], 'conditions': ['Breast Cancer', 'Surgery']}, 'descriptionModule': {'briefSummary': 'The Limbo study is a retrospective descriptive study which aims to establish the current state of breast reconstruction surgery at the Besançon University Hospital and Hôpital Nord Franche-Comté, between October 2017 and December 2021.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient who has undergone breast reconstruction using lipomodelling alone or in association with a flap (greater dorsal, DIEP Deep Inferior Epigastric Perforator flap or TRAM Tranverse Rectus Abdominis Myocutaneous Flap)', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who has undergone breast reconstruction using lipomodelling alone or in association with a flap (greater dorsal, DIEP Deep Inferior Epigastric Perforator flap or TRAM Tranverse Rectus Abdominis Myocutaneous Flap), since October 2017.\n\nPatient whose follow-up in plastic surgery is considered completed (final result obtained, patient lost to follow-up or not wishing to continue) at the time of data collection.\n\nExclusion Criteria:\n\n* Patient under 18 at first consultation\n* Opposition of the patient to the collection of her data'}, 'identificationModule': {'nctId': 'NCT06101732', 'acronym': 'LIMBO', 'briefTitle': 'LIMBO : Breast Reconstruction by Lipomodeling Alone or With Flap: Evaluation in Franche-Comté', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Besancon'}, 'officialTitle': 'Breast Reconstruction by Lipomodeling Alone or With Flap: Evaluation in Franche-Comté', 'orgStudyIdInfo': {'id': '2022/684'}}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU de besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Besancon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}