Living Conditions and Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01626950
First received: June 21, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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).


Condition
Breast Neoplasms

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Living Conditions and Breast Cancer

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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).


Enrollment: 684
Study Start Date: May 2012
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01626950

Locations
France
IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique
Montpellier Cedex 5, France, 34093
Registre Tumeurs de l'Hérault
Montpellier Cedex 5, France, 34298
Equipe Démographie Santé
Montpellier Cedex 5, France, 34298
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Jean Pierre Daurès, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01626950     History of Changes
Other Study ID Numbers: AO/INCA/2011/JPD, 2012-A00377-36
Study First Received: June 21, 2012
Last Updated: March 3, 2014
Health Authority: France: Committee for the Protection of Personnes
France: The Commission nationale de l’informatique et des libertés

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Breast cancer
living conditions
social fragility

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 25, 2014