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Living Conditions and Breast Cancer

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ClinicalTrials.gov Identifier: NCT01626950
Recruitment Status : Completed
First Posted : June 25, 2012
Last Update Posted : March 26, 2015
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

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).

Condition or disease
Breast Neoplasms

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
Actual Enrollment : 684 participants
Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Living Conditions and Breast Cancer
Study Start Date : May 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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.



Primary Outcome Measures :
  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). [ 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).



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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01626950


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

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 ( Other Identifier: RCB number )
First Posted: June 25, 2012    Key Record Dates
Last Update Posted: March 26, 2015
Last Verified: March 2015

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

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