Ignite Creation Date:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-26 @ 3:08 AM
Study NCT ID:
NCT01434420
Status:
UNKNOWN
Last Update Posted:
2014-12-31
First Post:
2011-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Triple Negative Breast Cancer: Study of Molecular and Genetic Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D064726', 'term': 'Triple Negative 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2020-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-30', 'studyFirstSubmitDate': '2011-09-13', 'studyFirstSubmitQcDate': '2011-09-13', 'lastUpdatePostDateStruct': {'date': '2014-12-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-09-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incidence of BRCA1/2, PALB2, PTEN, PALB2 mutations', 'timeFrame': 'up to 1 month', 'description': '1\\) Determine the incidence of the BRCA1/2, PALB2, PTEN, PALB2 mutations in patients having at diagnosis a non metastatic triple negative breast cancer'}], 'secondaryOutcomes': [{'measure': 'molecular profiles', 'timeFrame': 'up to 1 month', 'description': '2\\) Determine by tissue micro- array and transcriptome the molecular profiles and their correlation with the presence of a mutation'}, {'measure': 'years relapse-free survival', 'timeFrame': 'at 5 years', 'description': '3\\) Determine the 5 years relapse-free survival in presence or not of a mutation, and according to the molecular profile of expression.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['triple negative breast cancer'], 'conditions': ['Breast Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.institutpaolicalmettes.fr/', 'label': 'sponsor web site'}]}, 'descriptionModule': {'briefSummary': 'Breast cancer triples negatives (TN; 15 % of the cases) are characterized by a high histoprognostic grade, a strong proliferation, a strong metastatic power, and a worse prognosis than the other forms of breast cancer. It is however a heterogenous group for histological and molecular level, but also for evolution. Most of the TN is part of the basal breast cancer subcategory. Until now, the medical treatment is based on chemotherapy.\n\nBreast cancers by constitutional mutation of BRCA1 / BRCA2 (5 % of breast cancers) are mostly of basal type and their prognostic seems better that what could be expected from high grade tumours and without hormonal receptors. They would be much more frequent in the TN group. However, at this day, no prospective study was led to estimate this incidence, or to study the intervention of other genes of predisposition, as well to analyse the links between this phenotype and their consequences at the germinal or somatic level, in terms of associated molecular changes and prognosis.\n\nThe purpose of this study is, on a prospective study, to lead a joined analysis at the germinal level, in search of mutations of the main genes of breast cancer predisposition (BRCA1/2, PALB2, PTEN, PALB2), and at the tumour level (tissue micro-array and transcriptome), by correlating these results to the main clinical parameters.\n\nThe 5 years relapse-free survival will also be estimated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* women \\> 18\n* non metastatic breast cancer\n* triple negative\n* 5 years follow-up\n* signed informed consent\n\nExclusion Criteria:\n\n* other cancer (except in situ)\n* metastases at diagnosis\n* impossibility of follow-up'}, 'identificationModule': {'nctId': 'NCT01434420', 'briefTitle': 'Triple Negative Breast Cancer: Study of Molecular and Genetic Factors', 'organization': {'class': 'OTHER', 'fullName': 'Institut Paoli-Calmettes'}, 'officialTitle': 'Triple Negative Breast Cancer: Study of Molecular and Genetic Factors', 'orgStudyIdInfo': {'id': 'SA03/IPC 2010-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Triple negative breast cancer', 'description': 'Triple negative breast cancer', 'interventionNames': ['Genetic: BRCA1 BRCA2 PTEN PALB2 mutation']}], 'interventions': [{'name': 'BRCA1 BRCA2 PTEN PALB2 mutation', 'type': 'GENETIC', 'description': 'detection of BRCA1 BRCA2 PTEN PALB2 mutation', 'armGroupLabels': ['Triple negative breast cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63011', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'Centre jean Perrin', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '13005', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital La Timone', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13009', 'city': 'Marseille', 'country': 'France', 'facility': 'Institut Paoli-Calmettes', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '06189', 'city': 'Nice', 'country': 'France', 'facility': 'Centre Antoine Lacassagne', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Jean-Marc EXTRA, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Paoli-Calmettes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Paoli-Calmettes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}