Breast NeoplasmsNCT01626950
Living Conditions and Breast Cancer
An observational study of Breast Neoplasms, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Neoplasms
- Type of treatment
- Injection or infusion
- How many people
- 684 participants
- Where
- 3 sitesFrance
- Study dates
- May 2012to 18 Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
IURC - Laboratoire de Biostatistique d'Epidémiologie et de Recherche Clinique
Montpellier, 34093
Equipe Démographie Santé
Montpellier, 34298
Registre Tumeurs de l'Hérault
Montpellier, 34298
About this study
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).
Read the 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
- Conditions
- Breast Neoplasms
- Keywords
- Breast cancer, living conditions, social fragility
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (Day 0; cross-sectional study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startMay 2012
- Primary completion18 Nov 2013
- Study completion18 Nov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 684 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Pierre Daurès, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01626950
- Sponsor's protocol ID
- AO/INCA/2011/JPD
- Other IDs
- 2012-A00377-36
- Status last verified
- Mar 2015
- First submitted
- 21 Jun 2012
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Orsini M, Tretarre B, Daures JP, Bessaoud F. Individual socioeconomic status and breast cancer diagnostic stages: a French case-control study. Eur J Public Health. 2016 Jun;26(3):445-50. doi: 10.1093/eurpub/ckv233. Epub 2016 Jan 28.
PubMed 26823441
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Conditions and Breast Cancer
- ClinicalTrials.gov ID
- NCT01626950
- Acronym / sponsor ID
- AO/INCA/2011/JPD
- Conditions
- Breast Neoplasms
- Keywords
- Breast cancer, living conditions, social fragility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 684 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- 18 Nov 2013 (actual)
- Study completion
- 18 Nov 2013 (actual)
- First posted
- 25 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
- Patient has been correctly informed about the study, and agrees to participate
- The patient must be insured or beneficiary of a health insurance plan
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Results publication: PubMed 26823441Orsini M, Tretarre B, Daures JP, Bessaoud F. Individual socioeconomic status and breast cancer diagnostic stages: a French case-control study. Eur J Public Health. 2016 Jun;26(3):445-50. doi: 10.1093/eurpub/ckv233. Epub 2016 Jan 28.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Pierre Daurès, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by Centre Hospitalier Universitaire de Nīmes at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01626950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.