Clinical trial NCT01626950: Living Conditions and Breast Cancer
Official title: Living Conditions and Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Keywords: Breast cancer
living conditions
social fragility
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-06-25
Enrollment: 684
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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).

Detailed description: Our secondary objectives include:

* To study the link between cancer stage at diagnosis and diverse parameters describing living conditions
* 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
* To study patient quality of life at study baseline

Eligibility criteria: Inclusion Criteria (for cases):

* Patient has been correctly informed about the study, and agrees to participate
* The patient must be insured or beneficiary of a health insurance plan
* Incident breast cancer cases (diagnosis based on pathology) excluding sarcoma, classifiable as stage III-IV, surgical cases

Inclusion Criteria (for controls):

* Patient has been correctly informed about the study, and agrees to participate
* The patient must be insured or beneficiary of a health insurance plan
* Incident breast cancer cases (diagnosis based on pathology) excluding sarcoma, classifiable as stage I-II, surgical cases

Exclusion Criteria (for cases and controls):

* The patient is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient is pregnant, parturient, or breastfeeding
* The patient is opposed to study participation
* Women not able to answer a questionnaire due to language barriers or due to vascular or degenerative cerebral dysfunction
* It is impossible to correctly inform the patient

Primary outcomes:
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)
Secondary outcomes:
Other outcomes:
Locations:
city: Montpellier Cedex 5
country: France
facility: IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique
city: Montpellier Cedex 5
country: France
facility: Equipe Démographie Santé
city: Montpellier Cedex 5
country: France
facility: Registre Tumeurs de l'Hérault
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Jean Pierre Daurès, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: