Ignite Creation Date:
2025-12-26 @ 12:13 PM
Ignite Modification Date:
2026-03-17 @ 4:48 AM
Study NCT ID:
NCT01522300
Status:
TERMINATED
Last Update Posted:
2013-11-21
First Post:
2012-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité Tomos Study- Contribution of Tomosynthesis In Locoregional Pretherapeutic Staging of a Breast Tumor: Multicentricity Search
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], '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'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'whyStopped': 'No more inclusions since august 2013', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-20', 'studyFirstSubmitDate': '2012-01-18', 'studyFirstSubmitQcDate': '2012-01-27', 'lastUpdatePostDateStruct': {'date': '2013-11-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To calculate the sensitivity and specificity of both types of imaging (mammography and Tomosynthesis) with respect to number of tumors multicentric and multifocal identified through MRI.', 'timeFrame': 'January 2013', 'description': 'To calculate the sensitivity and specificity of both types of imaging (mammography and Tomosynthesis) with respect to number of tumors multicentric and multifocal identified through MRI. The other parameters VPN, VPP will also be calculated and discussed.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Tomosynthesis', 'breast cancer', 'specificity', 'sensitivity', 'To assess efficacy of Tomosynthesis by evaluating its sensitivity and specificity in detecting the multicentricity of mammary tumor'], 'conditions': ['Mammary Tumor']}, 'descriptionModule': {'briefSummary': 'The main objective of the study is to assess the sensitivity and specificity of Tomosynthesis in detecting the multicentricity of mammary tumor.', 'detailedDescription': 'The secondaries objectives of the study are:\n\n* Sensitivity and specificity in detecting multifocality of breast tumor\n* Sensitivity and specificity of Tomosynthesis in the detection of contralateral tumors\n* Predetermination of potential targets for ultrasound'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age\\> 18 years.\n* Patients with a breast tumor, regardless of the stage and size\n* Compulsory affiliation to a social security system.\n* Obtaining informed consent in writing, signed and dated.\n\nExclusion Criteria:\n\n* Patients with cognitive or psychiatric disorders.\n* Patient deprived of liberty by a court or administrative.\n* Patients with indications against the achievement of MRI, mammography and tomosynthesis\n* Pregnant Women'}, 'identificationModule': {'nctId': 'NCT01522300', 'briefTitle': "Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité Tomos Study- Contribution of Tomosynthesis In Locoregional Pretherapeutic Staging of a Breast Tumor: Multicentricity Search", 'organization': {'class': 'OTHER', 'fullName': 'Centre Jean Perrin'}, 'officialTitle': "Etude Tomos- Apport de la Tomosynthèse Dans le Bilan d'Extension locorégional préthérapeutique d'Une Tumeur du Sein : Recherche de multicentricité", 'orgStudyIdInfo': {'id': 'TOMOS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Evaluation of the Tomosynthesis', 'type': 'OTHER', 'description': 'An exam by tomosynthesis will be realised at the inclusion of the patient in the study.'}, {'name': 'Avaluation of a medical device: the tomosynthesis', 'type': 'OTHER', 'description': 'An exam by tomosynthesis will be realised at the inclusion of the patient in the study'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre Jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Jean Perrin', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}