Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2026-01-01 @ 1:41 PM
Study NCT ID:
NCT01035268
Status:
TERMINATED
Last Update Posted:
2018-08-22
First Post:
2009-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 196}}, 'statusModule': {'whyStopped': 'Slow recruitment rate', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-02-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2009-12-14', 'studyFirstSubmitQcDate': '2009-12-17', 'lastUpdatePostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Verify that the disturbances of the radiological follow-up in 1 year will not be more frequent for the patient benefiting from fatty transfer with regard to a simple surveillance.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Estimate the technique on the cosmetic plan : On the quality and on the stability of the result. On the satisfaction of the patient.', 'timeFrame': '1 year'}, {'measure': 'Estimate the technique on the carcinological plan : Estimate the rate of local relapse and\\or in distance. Estimate the rate of survival of the patients.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['breast cancer treated by conservative surgery'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'This is a phase III randomized multi-center study of equivalence comparing the radiological follow-up for patients benefiting from the correction of the esthetical relapse of the preservative treatment by fatty transfer compared with a simple supervision.\n\nIt is planned that 440 patients participate in this study which plans to compare 2 groups of patients: a group of patients which will benefit from the surgical treatment by transfer of fatty tissue and a group of patients under simple supervision.\n\nfollow-up consultations are planned in 10 in 45 days post-surgery then at 3 months, 6 months, 12 months and 5 years to look for the expected unwanted effects in relation with the surgery but also to estimate the impact of the fatty transfer on the rate of local and\\\\or from a distance relapse.\n\nDuring these consultations, the surgeon and the patient will also estimate the cosmetic result of the surgery thanks to a questionnaire of cosmetic evaluation and to standardized photos.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of breast cancer treated by conservative surgery .\n* Normal inclusion radiological assessment normal (ACR1 or ACR2)\n* Moderate Deformations (Type I and II of the classification of Clough).\n* Delay with regard to the end of the radiotherapy superior or equal to one-year-old.\n* Moderated radio-dystrophies (\\< Grade 2 of the score LENT/SOMA).\n* Signature of the informed consent\n* Patient benefiting from social security\n* Patient of more than 18 years old\n\nExclusion Criteria:\n\n* Abnormal radiological assessment (ACR3, ACR4 or ACR5)\n* Absence of fatty excess .\n* radio surgical relapses with vast fibroses of the breast (\\> Grade 2 of the score LENT/SOMA).\n* Patient under 18 years old.\n* administrative difficulties: impossibility to provide enlightened information to the patient, the refusal to sign the consent .\n* pregnant women or breast feeding women\n* patient under legal guardianship\n* bilateral breast cancer regardless histologic type.'}, 'identificationModule': {'nctId': 'NCT01035268', 'acronym': 'GRATSEC', 'briefTitle': 'Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella', 'organization': {'class': 'OTHER', 'fullName': 'Institut Claudius Regaud'}, 'officialTitle': 'Adipose Tissue Transfer for Moderate Breast Cancer Conservative Treatment Sequella. Adipocyte Transplant for Esthetical Relapse Treatment of Breast Conservative Treatment', 'orgStudyIdInfo': {'id': '08 SEIN 08'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'surgery by fatty tissue transfer', 'interventionNames': ['Procedure: fatty tissue transfer']}, {'type': 'NO_INTERVENTION', 'label': 'simple supervision'}], 'interventions': [{'name': 'fatty tissue transfer', 'type': 'PROCEDURE', 'description': 'It will be proceeded to aspiration of the fat at the level of the natural steatomeries (hip, stomach), then in a transfer of the fat prepared in the breast by following the standardized protocol.', 'armGroupLabels': ['surgery by fatty tissue transfer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'CHU de Besançon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '76230', 'city': 'Bois-Guillaume', 'country': 'France', 'facility': 'Clinique Saint Antoine', 'geoPoint': {'lat': 49.4602, 'lon': 1.12219}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'CHU Pellegrin', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '33076', 'city': 'Bordeaux', 'country': 'France', 'facility': 'Institut Bergonie', 'geoPoint': {'lat': 44.84124, 'lon': -0.58046}}, {'zip': '37145', 'city': 'Chambray-lès-Tours', 'country': 'France', 'facility': 'Pole de Sante de Leonard de Vinci', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Hopital Henri Mondor', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '69004', 'city': 'Lyon', 'country': 'France', 'facility': 'Centre Hospitalier La Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '69437', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital Edouard Herriot', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'CHR Marseille Conception', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13273', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "Centre Val d'Aurelle", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '44000', 'city': 'Nantes', 'country': 'France', 'facility': 'Clinique Brétéché', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75005', 'city': 'Paris', 'country': 'France', 'facility': 'INSTITUT CURIE - Site Paris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Saint Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Eugene Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '76038', 'city': 'Rouen', 'country': 'France', 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '92210', 'city': 'Saint-Cloud', 'country': 'France', 'facility': 'INSTITUT CURIE - René Huguenin', 'geoPoint': {'lat': 48.84598, 'lon': 2.20289}}, {'zip': '44805', 'city': 'Saint-Herblain', 'country': 'France', 'facility': "INSTITUT DE CANCEROLOGIE DE L'OUEST - Centre René Gauducheau", 'geoPoint': {'lat': 47.21154, 'lon': -1.651}}, {'zip': '67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Hôpitaux Universitaires de Strasbourg', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31000', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Institut Claudius Regaud', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Centre Alexis Vautrin', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '94805', 'city': 'Villejuif', 'country': 'France', 'facility': 'Institut Gustave Roussy', 'geoPoint': {'lat': 48.7939, 'lon': 2.35992}}], 'overallOfficials': [{'name': 'Ignacio GARRIDO, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Claudius Regaud'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Claudius Regaud', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}