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Living Conditions and Breast Cancer

This study is currently recruiting participants.
Verified March 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01626950
First received: June 21, 2012
Last updated: March 26, 2013
Last verified: March 2013
History of Changes

June 21, 2012
March 26, 2013
June 2012
June 2014   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01626950 on ClinicalTrials.gov Archive Site
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Living Conditions and Breast Cancer
Living Conditions and Breast Cancer

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).

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
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Non-Probability Sample

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 hae at least 2 controls, matched according to age +- 2 years.
Breast Neoplasms
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  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
June 2014
June 2014   (final data collection date for primary outcome measure)

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
Female
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No
Contact: Jean Pierre Daurès, MD PhD +33.(0)4.66.68.34.03 jean.pierre.daures@chu-nimes.fr
Contact: Carey M Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr
France
 
NCT01626950
AO/INCA/2011/JPD, 2012-A00377-36
No
Centre Hospitalier Universitaire de Nīmes
Centre Hospitalier Universitaire de Nīmes
Not Provided
Principal Investigator: Jean Pierre Daurès, MD PhD Centre Hospitalier Universitaire de Nîmes
Centre Hospitalier Universitaire de Nīmes
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP