Living Conditions and Breast Cancer

Breast Neoplasms Clinical Trial

Official title:

Living Conditions and Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01626950
• Other study ID #: AO/INCA/2011/JPD
• Secondary ID: 2012-A00377-36
• Status: Completed
• Phase: N/A
• First received: June 21, 2012
• Last updated: March 25, 2015
• Start date: May 2012
• Est. completion date: November 2013

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Committee for the Protection of PersonnesFrance: The Commission nationale de l’informatique et des libertés
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 684
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
France	Equipe Démographie Santé	Montpellier Cedex 5
France	IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique	Montpellier Cedex 5
France	Registre Tumeurs de l'Hérault	Montpellier Cedex 5

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No