Study Evaluating Intervention in the Development of Clinical Research in Non-Academic Health Institution (ERNU)

NCT ID: NCT02765451

Last Updated: 2019-07-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2019-02-21

Brief Summary

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This study evaluates the interventions of the Cancéropôle Nord-Ouest in the development of clinical research in non-academic health institution. The randomization, in open label,determines the duration of the interventions. Half of participants will receive the interventions during 2 years, while the other half during 1 year.

Detailed Description

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French National recommendations ask to increase the accessibility of patients to clinical trials. But this accessibility is far from the optimal care in non-university healthcare institutions (public and private hospital). These non-academic healthcare facilities support at national level about 60% of chemotherapy and 70% of radiotherapy, but only 17% of the inclusions in trials.

A dissociation exist between a care package guaranteed on quality criteria (criteria to obtain the capacity to treat the cancers in healthcare institution) distributed all over the country, and the research, mainly concentrated in few referral centers (University hospital and French Comprehensive Cancer Centers).

Clinical trials allow patients to have early access to new treatments, optimal and formalized information, and supported by physicians in connection with a strict protocol for patients included.

Several studies have shown the existence of geographical and socio-economic determinants for access to reference centers and for the duration of survival of cancer patients. In France, it was found that for patients with gastrointestinal cancer, the remoteness of the place of residence compared to the nearest referral center and a higher level of deprivation decreased the probability of being supported in a reference center.

The hypothesis of the ERNU study is that aid from the Cancéropole Nord-Ouest facilitates clinical research activity resulting in a significant development of inclusions in non-university centers of the french north-west inter-region with an influence on the social and geographical inequalities recruitment.

Conditions

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Clinical Research Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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A : 1 year of intervention

interventions of Cancéropôle Nord-Ouest during 1 year after an observational period of 2 years.

Group Type ACTIVE_COMPARATOR

interventions of the Cancéropôle Nord-Ouest

Intervention Type BEHAVIORAL

During the time defined by the randomization, the Cancéropôle Nord-Ouest offers to help to develop a clinical research activities in the centers. The various aids are : Structuring clinical research at the local level, Support (strategy, logistics, technical, Data management, methodology), a portfolio of "straightforward" studies ( French National Cancer Institute, cooperative groups conducting cancer clinical research, New Project), Good Clinical Practice training, Clinical research technician, Others,.....

B : 2 years of intervention

interventions of Cancéropôle Nord-Ouest during 2 years after an observational period of 1 year.

Group Type ACTIVE_COMPARATOR

interventions of the Cancéropôle Nord-Ouest

Intervention Type BEHAVIORAL

During the time defined by the randomization, the Cancéropôle Nord-Ouest offers to help to develop a clinical research activities in the centers. The various aids are : Structuring clinical research at the local level, Support (strategy, logistics, technical, Data management, methodology), a portfolio of "straightforward" studies ( French National Cancer Institute, cooperative groups conducting cancer clinical research, New Project), Good Clinical Practice training, Clinical research technician, Others,.....

Interventions

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interventions of the Cancéropôle Nord-Ouest

During the time defined by the randomization, the Cancéropôle Nord-Ouest offers to help to develop a clinical research activities in the centers. The various aids are : Structuring clinical research at the local level, Support (strategy, logistics, technical, Data management, methodology), a portfolio of "straightforward" studies ( French National Cancer Institute, cooperative groups conducting cancer clinical research, New Project), Good Clinical Practice training, Clinical research technician, Others,.....

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* French Health institutions of the Basse-Normandie, Haute-Normandie, Nord-Pas-de-Calais and Picardie.
* Health institutions non-academic public and private.
* Health institutions authorized to treat cancer.

Exclusion Criteria

* N/A
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre de traitement des données du Cancéropôle Nord-Ouest, Centre F. BACLESSE, Caen, France

UNKNOWN

Sponsor Role collaborator

Institut National de la Santé et de la Recherche Médical (INSERM) 1086 (Pr Guy LAUNOY) Centre F. BACLESSE, Caen, France

UNKNOWN

Sponsor Role collaborator

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-Claude BARBARE, MD

Role: STUDY_DIRECTOR

Centre Hospitalier Universitaire Amiens Picardie

Locations

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Centre hospitalier d'Abbeville

Abbeville, , France

Site Status

Clinique de l'Europe

Amiens, , France

Site Status

Clinique Victor Pauchet

Amiens, , France

Site Status

Hopital Privé d'Arras

Arras, , France

Site Status

Centre hospitalier d'Arras

Arras, , France

Site Status

Centre de Radiothérapie de la Baie

Avranches, , France

Site Status

Centre Hospitalier de Bayeux

Bayeux, , France

Site Status

Clinique du Parc Saint Lazare

Beauvais, , France

Site Status

Centre hospitalier de Beauvais

Beauvais, , France

Site Status

Centre de Radiothérapie Pierre Curie

Beuvry, , France

Site Status

Centre Hospitalier de Béthune

Béthune, , France

Site Status

Centre Hospitalier de Boulogne sur Mer

Boulogne-sur-Mer, , France

Site Status

Centre de Radiothérapie Maurice TUBIANA

Caen, , France

Site Status

Polyclinique du Parc

Caen, , France

Site Status

Centre hospitalier de Calais

Calais, , France

Site Status

Centre Hospitalier de Cherbourg

Cherbourg, , France

Site Status

Centre hospitalier Compiègne-Noyon

Compiègne, , France

Site Status

Clinique Saint Côme

Compiègne, , France

Site Status

Clinique de Flandre

Coudekerque-Branche, , France

Site Status

Centre hospitalier Creil-Senlis

Creil, , France

Site Status

Centre Hospitalier de Dunkerque

Dunkirk, , France

Site Status

Centre Hospitalier intercommunal Eure-Seine

Évreux, , France

Site Status

Centre hospitalier de Flers

Flers, , France

Site Status

Centre Hospitalier de Granville

Granville, , France

Site Status

Centre Hospitalier d'Hazebrouck

Hazebrouck, , France

Site Status

Centre hospitalier de Saint Omer

Helfaut, , France

Site Status

Centre hospitalier de Laon

Laon, , France

Site Status

Centre Hospitalier du Havre

Le Havre, , France

Site Status

Centre Hospitalier de Lens

Lens, , France

Site Status

Centre de radiuothérapie Bourgogne

Lille, , France

Site Status

Centre Hospitalier d'arrondissement de Montreuil sur mer

Rang-du-Fliers, , France

Site Status

Clinique Mathilde

Rouen, , France

Site Status

Centre Hospitalier intercommunal d'Elbeuf-Louvier

Saint-Aubin-lès-Elbeuf, , France

Site Status

Clinique les Aubépines

Saint-Aubin-sur-Scie, , France

Site Status

Clinique de la Baie

Saint-Martin-des-Champs, , France

Site Status

Clinique de Saint-Omer

Saint-Omer, , France

Site Status

Clinique Saint Claude

Saint-Quentin, , France

Site Status

Centre hospitalier de Saint Quentin

Saint-Quentin, , France

Site Status

Centre hospitalier de Soissons

Soissons, , France

Site Status

Centre Hospitalier de Tourcoing

Tourcoing, , France

Site Status

Centre hospitalier de Valenciennes

Valenciennes, , France

Site Status

Countries

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France

Other Identifiers

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RNI 2015-05-DR-BARBARE

Identifier Type: -

Identifier Source: org_study_id

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