Living Conditions and Breast Cancer

March 25, 2015 updated by: Centre Hospitalier Universitaire de Nīmes
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).

Study Overview

Status

Completed

Conditions

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

Study Type

Observational

Enrollment (Actual)

684

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier Cedex 5, France, 34093
        • IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique
      • Montpellier Cedex 5, France, 34298
        • Equipe Démographie Santé
      • Montpellier Cedex 5, France, 34298
        • Registre Tumeurs de l'Hérault

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 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).
Baseline (Day 0; cross-sectional study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nīmes

Investigators

  • Principal Investigator: Jean Pierre Daurès, MD PhD, Centre Hospitalier Universitaire de Nîmes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

November 1, 2013

Study Registration Dates

First Submitted

June 21, 2012

First Submitted That Met QC Criteria

June 21, 2012

First Posted (Estimate)

June 25, 2012

Study Record Updates

Last Update Posted (Estimate)

March 26, 2015

Last Update Submitted That Met QC Criteria

March 25, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AO/INCA/2011/JPD
  • 2012-A00377-36 (Other Identifier: RCB number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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