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Living Conditions and Breast Cancer

Living Conditions and Breast Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01626950
Enrollment
684
Registered
2012-06-25
Start date
2012-05-31
Completion date
2013-11-18
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Breast cancer, living conditions, social fragility

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

Interventions

None listed

Sponsors

Centre Hospitalier Universitaire de Nīmes
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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).Baseline (Day 0; cross-sectional study)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).

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026