Breast CancerDESSEINNCT02948478
Economic and Social Disparities and Breast Cancer
An observational study of Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 24 sites in France.
Trial summary
Precariousness is a multifactorial concept that can be broken down in the form of economic insecurity, and / or social insecurity and / or territorial insecurity. Precariousness has an impact on health that is difficult to assess precisely because it also impacts on other factors that may themselves influence health. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exposed and Non exposed
- How many people
- 936 participants
- Where
- 24 sitesFrance
- Study dates
- Dec 2016to 23 Feb 2021
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients from Ile de France area having a breast cancer histologically proved and seeking for treatment. Any patient consulting for the first time in a specialized center for the treatment of breast cancer in Ile de France, whatever the stage of the disease, may potentially be recruited.
Who may be able to join
- Patients ? 18 years old having a breast cancer histologically proved
Who cannot join
- Patients with a history of cancer treated in the previous five years, or with another associated untreated cancer
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites
Centre Hopitalier Victor Dupouy Argenteuil
Argenteuil
Hôpital Jean Verdier
Bondy, 94143
Centre Hospitalier de Pontoise
Cergy-Pontoise
Hopital Privé Paule Egine
Champigny-sur-Marne
CH Sud Francilien
Corbeil-Essonnes
Centre Hospitalier Intercommunal Créteil
Créteil, 94000
Hôpital Henri Mondor
Créteil, 94010
Clinique Claude Bernard
Ermont
CH de Lagny sur Marne
Lagny-sur-Marne, 77400
Hôpital Bicêtre
Le Kremlin-Bicêtre
Institut de Cancérologie Hartmann
Levallois-Perret, 92300
Institut Curie Hôpital de Paris
Paris, 75005
Hôpital Lariboisière
Paris, 75010
Hôpital Saint-Louis
Paris, 75010
Hôpital Privé des Peupliers
Paris, 75013
HEGP
Paris, 75015
Hôpital Tenon
Paris, 75020
Groupe Hospitalier Paris Saint-Joseph
Paris
Centre Hospitalier Intercommunal Poissy Saint Germain en Laye
Poissy, 78300
Institut Curie Hôpital René-Huguenin site Saint-Cloud
Saint-Cloud, 92210
Centre Hospitalier Delafontaine
Saint-Denis, 93200
Institut de cancérologie Paris Nord
Sarcelles
Clinique de l'Estrée
Stains
Centre Hospitalier de Versailles
Versailles, 78157
About this study
Official title: Breast Cancer and Precariousness: Influence of Socio-demographic Inequalities in Cancer Stage at Diagnosis, Treatment Management and Rehabilitation in the Ile de France Area
Precariousness is a multifactorial concept that can be broken down in the form of economic insecurity, and / or social insecurity and / or territorial insecurity. Precariousness has an impact on health that is difficult to assess precisely because it also impacts on other factors that may themselves influence health. Therefore, the understanding of the impact of precariousness on health involves studying individuals in their context.
Our study is designed to assess the impact of precariousness on the history of breast cancer, on care pathways, on treatment and rehabilitation in a multidisciplinary contextual analysis. Indeed, the socio -economic and geographical inequalities affect the history of breast cancer, treatment and its delay and post- treatment rehabilitation.
Read more
The main objective of this project is to compare the stage of disease at diagnosis (according to the TNM classification) in deprived and non deprived patients. The secondary objectives are to compare in the two groups - the socio-economic and geographical inequalities - the direct and indirect costs related to the management, the out-of pocket costs and to describe, based on individual inequalities identified, the pathway of care of the patient.
These objectives will be pursued in the framework of an observational cohort study, prospective, multicenter (Ile de France) comparative exposed / unexposed category. Each precarious patient will be matched to a non- precarious patient in the same age group, regardless of the center. The study will include any patient resident in Ile de France seeking treatment for breast cancer, regardless of the stage.
Read the detailed description
All patients seeking treatment for breast cancer, regardless of the stage, can be included in the study. Three scores of precariousness will be applied to all patients (EPICES score, Pascal score and the European Deprivation Index). Patients identified as precarious by at least one of those three scales will be in the exposed group. The others will be in the non-exposed group.
Baseline assessment T0:
Are required only the clinical examination and radiological evaluation with the tumor size and node involvement according to TNM classification. A questionnaire will be distributed including EPICES score, Pascal score and European Deprivation Index. The baseline questionnaire will also assess the socio-economic characteristics of patients and the care trajectory before arriving in the center (see appendix).
Follow-up visits:
The following questionnaire will be distributed during a consultation that is scheduled in the routine care. There will be no additional consultation imposed on the patient.
- T1: questionnaire at 3 months after inclusion
- T2: questionnaire at 6 months after inclusion
- T3: questionnaire at 12 months after inclusion
Questionnaires will be focused on direct-costs and out-of-pocket costs, socio-economical characteristics, rehabilitation, return to work.
- Conditions
- Breast Cancer
- Being tested
- Exposed, Non exposed
- Keywords
- precariousness, care pathways
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExposedOther
Precarious patients
Non exposedOther
Non precarious patients
| Study group | Role | What they receive |
|---|---|---|
| Precarious patients | Precarious patients - exposed - will be those identified as precarious by at least one of the three scores (EPICES, Pascal, European Deprivation Index) Receives: Other: Exposed | |
| Non precarious patients | Non precarious patient - non exposed - will be all the patients identified as non-precarious by the three scores (EPICES, Pascal, European Deprivation Index) Receives: Other: Non exposed |
What is being measured
The primary outcome is the main question the study is designed to answer.
TNM stage
TNM classification according to initial clinical and radiological assessment
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2016 (estimated)
- Study startDec 2016
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
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 CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Prospective
- Enrolment
- 936 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute, France, Paris West University Nanterre La Défense, Paris 12 Val de Marne University, Fondation Ophtalmologique Adolphe de Rothschild
- Responsible party
- Sponsor
- Investigators
- Charlotte NGO, MD, Principal investigator, AP - HP, Hôpital Européen Georges-Pompidou, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02948478
- Sponsor's protocol ID
- K160202
- Other IDs
- ID RCB 2016-A00589-42
- Acronym
- DESSEIN
- Status last verified
- Dec 2021
- First submitted
- 26 Oct 2016
- Last updated
- 21 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Ngo C, Dinut A, Bochaton A, Charreire H, Despres C, Baffert S, Lecuru F, Chatellier G. From prospective clinical trial to reducing social inequalities in health: The DESSEIN trial, concept and design of a multidisciplinary study in precarious patients with breast cancer. BMC Public Health. 2019 Nov 4;19(1):1450. doi: 10.1186/s12889-019-7611-6.
PubMed 31684919
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer and Precariousness: Influence of Socio-demographic Inequalities in Cancer Stage at Diagnosis, Treatment Management and Rehabilitation in the Ile de France Area
- ClinicalTrials.gov ID
- NCT02948478
- Acronym / sponsor ID
- DESSEIN / K160202
- Conditions
- Breast Cancer
- Keywords
- precariousness, care pathways
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 936 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- National Cancer Institute, France, Paris West University Nanterre La Défense, Paris 12 Val de Marne University, Fondation Ophtalmologique Adolphe de Rothschild
- Study start
- Dec 2016 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 28 Oct 2016 (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.
Precariousness is a multifactorial concept that can be broken down in the form of economic insecurity, and / or social insecurity and / or territorial insecurity. Precariousness has an impact on health that is difficult to assess precisely because it also impacts on other factors that may themselves influence health. Therefore, the understanding of the impact of precariousness on health involves studying individuals in their context.
Our study is designed to assess the impact of precariousness on the history of breast cancer, on care pathways, on treatment and rehabilitation in a multidisciplinary contextual analysis. Indeed, the socio -economic and geographical inequalities affect the history of breast cancer, treatment and its delay and post- treatment rehabilitation.
The main objective of this project is to compare the stage of disease at diagnosis (according to the TNM classification) in deprived and non deprived patients. The secondary objectives are to compare in the two groups - the socio-economic and geographical inequalities - the direct and indirect costs related to the management, the out-of pocket costs and to describe, based on individual inequalities identified, the pathway of care of the patient.
These objectives will be pursued in the framework of an observational cohort study, prospective, multicenter (Ile de France) comparative exposed / unexposed category. Each precarious patient will be matched to a non- precarious patient in the same age group, regardless of the center. The study will include any patient resident in Ile de France seeking treatment for breast cancer, regardless of the stage.
Detailed description
All patients seeking treatment for breast cancer, regardless of the stage, can be included in the study. Three scores of precariousness will be applied to all patients (EPICES score, Pascal score and the European Deprivation Index). Patients identified as precarious by at least one of those three scales will be in the exposed group. The others will be in the non-exposed group.
Baseline assessment T0:
Are required only the clinical examination and radiological evaluation with the tumor size and node involvement according to TNM classification. A questionnaire will be distributed including EPICES score, Pascal score and European Deprivation Index. The baseline questionnaire will also assess the socio-economic characteristics of patients and the care trajectory before arriving in the center (see appendix).
Follow-up visits:
The following questionnaire will be distributed during a consultation that is scheduled in the routine care. There will be no additional consultation imposed on the patient.
- T1: questionnaire at 3 months after inclusion
- T2: questionnaire at 6 months after inclusion
- T3: questionnaire at 12 months after inclusion
Questionnaires will be focused on direct-costs and out-of-pocket costs, socio-economical characteristics, rehabilitation, return to work.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precarious patients | – | Other: ExposedPrecarious patients - exposed - will be those identified as precarious by at least one of the three scores (EPICES, Pascal, European Deprivation Index) |
| Non precarious patients | – | Other: Non exposedNon precarious patient - non exposed - will be all the patients identified as non-precarious by the three scores (EPICES, Pascal, European Deprivation Index) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients from Ile de France area having a breast cancer histologically proved and seeking for treatment. Any patient consulting for the first time in a specialized center for the treatment of breast cancer in Ile de France, whatever the stage of the disease, may potentially be recruited.
Key inclusion criteria (1 listed)
- Patients ? 18 years old having a breast cancer histologically proved
Key exclusion criteria (1 listed)
- Patients with a history of cancer treated in the previous five years, or with another associated untreated cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExposedPrecarious patients | Other | Precarious patients |
| Non exposedNon precarious patients | Other | Non precarious patients |
Primary outcome
TNM stage
Time frame: Baseline
TNM classification according to initial clinical and radiological assessment
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 21 Dec 2021.
- Derived from this study: PubMed 31684919Ngo C, Dinut A, Bochaton A, Charreire H, Despres C, Baffert S, Lecuru F, Chatellier G. From prospective clinical trial to reducing social inequalities in health: The DESSEIN trial, concept and design of a multidisciplinary study in precarious patients with breast cancer. BMC Public Health. 2019 Nov 4;19(1):1450. doi: 10.1186/s12889-019-7611-6.
- Individual participant dataSharing planned: Undecided
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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.
Charlotte NGO, MD principal investigator
AP - HP, Hôpital Européen Georges-Pompidou, Paris, France
24 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 Cancer, run by Assistance Publique - Hôpitaux de Paris at 24 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 1 inclusion and 1 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 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 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?
TNM stage (time frame: Baseline). 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 NCT02948478, 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 21 Dec 2021.