NCT02948478

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
936

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2021

Completed
Last Updated

December 21, 2021

Status Verified

December 1, 2021

Enrollment Period

4.2 years

First QC Date

October 26, 2016

Last Update Submit

December 20, 2021

Conditions

Keywords

precariousnesscare pathways

Outcome Measures

Primary Outcomes (1)

  • TNM stage

    TNM classification according to initial clinical and radiological assessment

    Baseline

Study Arms (2)

Precarious patients

Precarious patients - exposed - will be those identified as precarious by at least one of the three scores (EPICES, Pascal, European Deprivation Index)

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)

Other: Non exposed

Interventions

ExposedOTHER

Precarious patients

Precarious patients

Non precarious patients

Non precarious patients

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • \- Patients ? 18 years old having a breast cancer histologically proved

You may not qualify if:

  • \- Patients with a history of cancer treated in the previous five years, or with another associated untreated cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Centre Hopitalier Victor Dupouy Argenteuil

Argenteuil, France

Location

Hôpital Jean Verdier

Bondy, 94143, France

Location

Centre Hospitalier de Pontoise

Cergy-Pontoise, France

Location

Hopital Privé Paule Egine

Champigny-sur-Marne, France

Location

CH Sud Francilien

Corbeil-Essonnes, France

Location

Centre Hospitalier Intercommunal Créteil

Créteil, 94000, France

Location

Hôpital Henri Mondor

Créteil, 94010, France

Location

Clinique Claude Bernard

Ermont, France

Location

CH de Lagny sur Marne

Lagny-sur-Marne, 77400, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Location

Institut de Cancérologie Hartmann

Levallois-Perret, 92300, France

Location

Institut Curie Hôpital de Paris

Paris, 75005, France

Location

Hôpital Lariboisière

Paris, 75010, France

Location

Hôpital Saint-Louis

Paris, 75010, France

Location

Hôpital Privé des Peupliers

Paris, 75013, France

Location

HEGP

Paris, 75015, France

Location

Hôpital Tenon

Paris, 75020, France

Location

Groupe Hospitalier Paris Saint-Joseph

Paris, France

Location

Centre Hospitalier Intercommunal Poissy Saint Germain en Laye

Poissy, 78300, France

Location

Institut Curie Hôpital René-Huguenin site Saint-Cloud

Saint-Cloud, 92210, France

Location

Centre Hospitalier Delafontaine

Saint-Denis, 93200, France

Location

Institut de cancérologie Paris Nord

Sarcelles, France

Location

Clinique de l'Estrée

Stains, France

Location

Centre Hospitalier de Versailles

Versailles, 78157, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Charlotte NGO, MD

    AP - HP, Hôpital Européen Georges-Pompidou, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 26, 2016

First Posted

October 28, 2016

Study Start

December 1, 2016

Primary Completion

February 23, 2021

Study Completion

February 23, 2021

Last Updated

December 21, 2021

Record last verified: 2021-12

Locations