NCT01626950

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
684

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2012

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 18, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 18, 2013

Completed
Last Updated

November 19, 2025

Status Verified

March 1, 2015

Enrollment Period

1.6 years

First QC Date

June 21, 2012

Last Update Submit

November 17, 2025

Conditions

Keywords

Breast cancerliving conditionssocial fragility

Outcome Measures

Primary Outcomes (1)

  • 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).

    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).

    Baseline (Day 0; cross-sectional study)

Study Arms (2)

Cases - Stage III-IV breast cancer

The women in this group have been diagnosed with stage III-IV incident cancer.

Controls: Stage I-II breast cancer

The women in this group have been diagnosed with stage I-II incident cancer.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique

Montpellier, 34093, France

Location

Equipe Démographie Santé

Montpellier, 34298, France

Location

Registre Tumeurs de l'Hérault

Montpellier, 34298, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jean Pierre Daurès, MD PhD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2012

First Posted

June 25, 2012

Study Start

May 1, 2012

Primary Completion

November 18, 2013

Study Completion

November 18, 2013

Last Updated

November 19, 2025

Record last verified: 2015-03

Locations