Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT04888351
Status:
UNKNOWN
Last Update Posted:
2021-05-17
First Post:
2021-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Immediate Breast Reconstruction's Increasing
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008408', 'term': 'Mastectomy'}], 'ancestors': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 215}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2021-05-11', 'lastUpdatePostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Global complications's rates in 2 groups (percentage)", 'timeFrame': 'During first year after surgery', 'description': 'Comparison of complications between mastectomies with IBR and mastectomies without IBR'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Immediate Breast Reconstruction (IBR)', 'Mastectomy', 'Breast cancer'], 'conditions': ['Breast Reconstruction', 'Breast Cancer']}, 'descriptionModule': {'briefSummary': "Mastectomy in breast cancer is still a way of treatment. Nowadays, the goal is to improve reconstruction's technicals. Immediate Breast Reconstruction (IBR) is one of them, largely used in United States but less in France. However, IGR (Insitut Gustave Roussey) in Paris just wrote a new protocole wich allows more IBR by including more patients.\n\nThis study aims to compare complications in 2 groups: mastectomies followed by IBR and mastectomies without IBR. The second goal will try to estimate the proportion of eligible's patients to IBR, and to analyse their surgicals and oncologicals risk factors"}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Female patients aged 18 or more, who have had a mastectomy for breast cancer in Croix-Rousse's hospital in Lyon, between 1st of January 2016 and 31st of December 2020", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Over 18 years\n* Breast cancer\n* Mastectomy\n* Hopital de la Croix-Rousse\n* January 2016 and January 2020\n\nExclusion Criteria:\n\n* Prophylactic mastectomy\n* Male gender'}, 'identificationModule': {'nctId': 'NCT04888351', 'acronym': 'IBRI', 'briefTitle': "Immediate Breast Reconstruction's Increasing", 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': "Mastectomy and Breast Cancer : Follow-up of IBR's Rate and Study of Complications as Compared to Delayed Reconstructions Between 2016 and 2020 in Lyon", 'orgStudyIdInfo': {'id': '69HCL21_0145'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mastectomies with IBR', 'description': 'Every women\\>18 years who underwent mastectomies followed by IBR (prothesis, latissimus dorsi flap, lipofeeling, isolated or combined) for breast cancer in Hôpital de la Croix-Rousse between January 2016 and January 2020', 'interventionNames': ['Other: Comparison of complications between mastectomies with IBR and mastectomies without IBR', 'Other: To analyze variations of number of patients eligibles to IBR']}, {'label': 'Mastectomies without IBR', 'description': 'Every women\\>18 years who underwent mastectomies for breast cancer followed by delayed reconstructions (prothesis, latissimus dorsi flap, lipofeeling, isolated or combined) or no reconstructions between January 2016 and January 2020 in Hôpital de la Croix-Rousse', 'interventionNames': ['Other: Comparison of complications between mastectomies with IBR and mastectomies without IBR', 'Other: To analyze variations of number of patients eligibles to IBR']}], 'interventions': [{'name': 'Comparison of complications between mastectomies with IBR and mastectomies without IBR', 'type': 'OTHER', 'description': "Precocious complications (less than 3 months after surgery) are classified with Clavien's classification : hematoma, seroma, stitches, antibiotics, transfusion.\n\nTardive complications (after 3 months until 1 year) are more specifics : hematoma, seroma, tardive infections, asymmetry, removing of implant, breaking up of implant, skin necrosis, capsular contractures, implant loss, chronic pain.", 'armGroupLabels': ['Mastectomies with IBR', 'Mastectomies without IBR']}, {'name': 'To analyze variations of number of patients eligibles to IBR', 'type': 'OTHER', 'description': 'Including patients with differents classic risk factors : T3, T4, tobacco, diabetes, overweight and obesity, hypertension, age over 70, thoracic irradiation in the past', 'armGroupLabels': ['Mastectomies with IBR', 'Mastectomies without IBR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69004', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marion CORTET, MD', 'role': 'CONTACT', 'email': 'marion.cortet@chu-lyon.fr', 'phone': '4 27 85 40 78', 'phoneExt': '+33'}], 'facility': 'Hôpital de la Croix-Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}], 'centralContacts': [{'name': 'Marion CORTET, MD', 'role': 'CONTACT', 'email': 'marion.cortet@chu-lyon.fr', 'phone': '4 27 85 40 78', 'phoneExt': '+33'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}