Ignite Creation Date:
2025-12-24 @ 12:43 PM
Ignite Modification Date:
2025-12-27 @ 10:12 PM
Study NCT ID:
NCT00922961
Status:
COMPLETED
Last Update Posted:
2012-07-23
First Post:
2009-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer
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': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-20', 'studyFirstSubmitDate': '2009-06-15', 'studyFirstSubmitQcDate': '2009-06-16', 'lastUpdatePostDateStruct': {'date': '2012-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-06-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of the rate of Radiation-Induced CD8 T-Lymphocyte Apoptosis', 'timeFrame': 'Blood sample during a consultation'}], 'secondaryOutcomes': [{'measure': 'Assessment of the rate and scores of late fibrosis related to irradiation by mammosite', 'timeFrame': 'During a consultation with 2 physicians'}, {'measure': 'Assessment of the rate of telangiectasia', 'timeFrame': 'During a consultation with 2 physicians'}, {'measure': 'Assessment of the rate of sequellar pain', 'timeFrame': 'During a consultation with 2 physicians'}, {'measure': 'Assessment of the rate of seroma collection', 'timeFrame': 'During a consultation with 2 physicians'}, {'measure': 'Assessment of the breast esthetic score', 'timeFrame': 'During a consultation with 2 physicians'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['brachytherapy, late cutaneous toxicity'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '25 patients, treated by brachytherapy in a phase II study "Mammosite" (from 2003 to 2005), will be asked to attend a clinical exam in order to evaluate the late cutaneous toxicity due to brachytherapy.\n\nDuring this consultation, a blood sample will be taken for analysis ( rate of CD8 T-Lymphocyte Apoptosis)', 'detailedDescription': 'This is an interventional study for the french law'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patient treated by exclusive per-operative brachytherapy in the prior study Mammosite for breast cancer\n* Patient with social security\n\nExclusion Criteria:\n\n* Not applicable'}, 'identificationModule': {'nctId': 'NCT00922961', 'acronym': 'MAMMOSITE2', 'briefTitle': 'Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Oscar Lambret'}, 'officialTitle': 'Research for Predictive Biologic Parameters of Cutaneous Hypersensitivity After Brachytherapy in Breast Cancer', 'orgStudyIdInfo': {'id': 'MAMMOSITE2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cellular apoptosis', 'interventionNames': ['Biological: Blood sample', 'Procedure: Clinical exam']}], 'interventions': [{'name': 'Blood sample', 'type': 'BIOLOGICAL', 'description': 'Blood sample taken for the analysis of the rate of CD8 T-Lymphocyte Apoptosis', 'armGroupLabels': ['cellular apoptosis']}, {'name': 'Clinical exam', 'type': 'PROCEDURE', 'description': 'Assessment of the esthetic score, and the late cutaneous side effect by 2 physicians', 'armGroupLabels': ['cellular apoptosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '59020', 'city': 'Lille', 'country': 'France', 'facility': 'Centre Oscar Lambret', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}], 'overallOfficials': [{'name': 'Yazid BELKACEMI, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Oscar Lambret'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Oscar Lambret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}