Ignite Creation Date:
2025-12-24 @ 4:53 PM
Ignite Modification Date:
2025-12-29 @ 5:28 PM
Study NCT ID:
NCT01626950
Status:
COMPLETED
Last Update Posted:
2025-11-19
First Post:
2012-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Living Conditions and 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 684}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2013-11-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2012-06-21', 'studyFirstSubmitQcDate': '2012-06-21', 'lastUpdatePostDateStruct': {'date': '2025-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The odds ratio for having a stage I-II diagnosis versus a stage III-IV diagnosis according to EPICE score category (social fragility versus no social fragility).', 'timeFrame': 'Baseline (Day 0; cross-sectional study)', 'description': 'The main criterion is the estimation of the link (odds ratio) between the precariousness defined by the score SPICE (2 groups: precarious and insecure) and stage at diagnosis (2 groups: CAS: stages 1 or 2 the "good prognosis "versus the witnesses: stage 3 or 4 bad prognosis).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'living conditions', 'social fragility'], 'conditions': ['Breast Neoplasms']}, 'referencesModule': {'references': [{'pmid': '26823441', 'type': 'RESULT', 'citation': 'Orsini M, Tretarre B, Daures JP, Bessaoud F. Individual socioeconomic status and breast cancer diagnostic stages: a French case-control study. Eur J Public Health. 2016 Jun;26(3):445-50. doi: 10.1093/eurpub/ckv233. Epub 2016 Jan 28.'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to estimate of the link (odds ratio) between the precariousness defined by the score SPICE (2 groups: precarious and insecure) and stage at diagnosis (2 groups: CAS: stages 1 or 2 the "good prognosis "versus the witnesses: stage 3 or 4 bad prognosis).', 'detailedDescription': 'Our secondary objectives include:\n\n* To study the link between cancer stage at diagnosis and diverse parameters describing living conditions\n* To construct a new score for social fragility based on new data collected in this study, and to compare this score with the EPICES score\n* To study patient quality of life at study baseline'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study is a case-control study concerning the female population suffering from breast cancer in the Herault department of France. Only invasive cancers are taken into account. For each case, we will have at least 2 controls, matched according to age +- 2 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (for cases):\n\n* Patient has been correctly informed about the study, and agrees to participate\n* The patient must be insured or beneficiary of a health insurance plan\n* Incident breast cancer cases (diagnosis based on pathology) excluding sarcoma, classifiable as stage III-IV, surgical cases\n\nInclusion Criteria (for controls):\n\n* Patient has been correctly informed about the study, and agrees to participate\n* The patient must be insured or beneficiary of a health insurance plan\n* Incident breast cancer cases (diagnosis based on pathology) excluding sarcoma, classifiable as stage I-II, surgical cases\n\nExclusion Criteria (for cases and controls):\n\n* The patient is in an exclusion period determined by a previous study\n* The patient is under judicial protection, under tutorship or curatorship\n* The patient is pregnant, parturient, or breastfeeding\n* The patient is opposed to study participation\n* Women not able to answer a questionnaire due to language barriers or due to vascular or degenerative cerebral dysfunction\n* It is impossible to correctly inform the patient'}, 'identificationModule': {'nctId': 'NCT01626950', 'briefTitle': 'Living Conditions and Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nīmes'}, 'officialTitle': 'Living Conditions and Breast Cancer', 'orgStudyIdInfo': {'id': 'AO/INCA/2011/JPD'}, 'secondaryIdInfos': [{'id': '2012-A00377-36', 'type': 'OTHER', 'domain': 'ANSM'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cases - Stage III-IV breast cancer', 'description': 'The women in this group have been diagnosed with stage III-IV incident cancer.'}, {'label': 'Controls: Stage I-II breast cancer', 'description': 'The women in this group have been diagnosed with stage I-II incident cancer.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Montpellier', 'country': 'France', 'facility': "IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': 'Equipe Démographie Santé', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '34298', 'city': 'Montpellier', 'country': 'France', 'facility': "Registre Tumeurs de l'Hérault", 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Jean Pierre Daurès, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nîmes'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nīmes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}