Living Conditions and Breast Cancer
This study is currently recruiting participants.
Verified March 2013 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Centre Hospitalier Universitaire de Nīmes
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
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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).
| Estimated Enrollment: | 600 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | June 2014 (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 hae 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01626950
Contacts
| 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 |
Locations
| France | |
| IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique | Recruiting |
| Montpellier Cedex 5, France, 34093 | |
| Principal Investigator: Jean Pierre Daurès, MD PhD | |
| Sub-Investigator: Mattea Orsini, MD | |
| Registre Tumeurs de l'Hérault | Recruiting |
| Montpellier Cedex 5, France, 34298 | |
| Sub-Investigator: Trétarre Brigitte, Dr | |
| Equipe Démographie Santé | Recruiting |
| Montpellier Cedex 5, France, 34298 | |
| Sub-Investigator: Frédéric Balard, PhD | |
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 26, 2013 |
| 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 May 16, 2013