Clinical trial NCT02765451: Study Evaluating Intervention in the Development of Clinical Research in Non-Academic Health Institution (ERNU)
Official title: Randomized Trial Evaluating Intervention of the Cancéropôle Nord-Ouest in the Development of Clinical Research in Non-Academic Health Institutions (ERNU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinical Research
Cancer
Keywords: non-academic
health institution
development
clinical research
cancer
private hospital
public hospital
northwestern france
france
hospitals
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
Collaborators: name: Centre de traitement des données du Cancéropôle Nord-Ouest, Centre F. BACLESSE, Caen, France
name: Institut National de la Santé et de la Recherche Médical (INSERM) 1086 (Pr Guy LAUNOY) Centre F. BACLESSE, Caen, France
First posted: 2016-05-06
Enrollment: 40
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of inclusions in clinical trials of patients
timeFrame: up to 2 years
Secondary outcomes:
measure: Reduction of social inequalities recruitment in clinical trials associated with the intervention of the Cancéropôle Nord-Ouest
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Abbeville
country: France
facility: Centre hospitalier d'Abbeville
city: Amiens
country: France
facility: Clinique de l'Europe
city: Amiens
country: France
facility: Clinique Victor Pauchet
city: Arras
country: France
facility: Hopital Privé d'Arras
city: Arras
country: France
facility: Centre hospitalier d'Arras
city: Avranches
country: France
facility: Centre de Radiothérapie de la Baie
city: Bayeux
country: France
facility: Centre Hospitalier de Bayeux
city: Beauvais
country: France
facility: Clinique du Parc Saint Lazare
city: Beauvais
country: France
facility: Centre hospitalier de Beauvais
city: Beuvry
country: France
facility: Centre de Radiothérapie Pierre Curie
city: Boulogne sur Mer
country: France
facility: Centre Hospitalier de Boulogne sur Mer
city: Béthune
country: France
facility: Centre Hospitalier de Béthune
city: Caen
country: France
facility: Centre de Radiothérapie Maurice TUBIANA
city: Caen
country: France
facility: Polyclinique du Parc
city: Calais
country: France
facility: Centre hospitalier de Calais
city: Cherbourg
country: France
facility: Centre Hospitalier de Cherbourg
city: Compiègne
country: France
facility: Centre hospitalier Compiègne-Noyon
city: Compiègne
country: France
facility: Clinique Saint Côme
city: Coudekerque Branche
country: France
facility: Clinique de Flandre
city: Creil
country: France
facility: Centre hospitalier Creil-Senlis
city: Dunkerque
country: France
facility: Centre Hospitalier de Dunkerque
city: Evreux
country: France
facility: Centre Hospitalier intercommunal Eure-Seine
city: Flers
country: France
facility: Centre hospitalier de Flers
city: Granville
country: France
facility: Centre Hospitalier de Granville
city: Hazebrouck
country: France
facility: Centre Hospitalier d'Hazebrouck
city: Helfaut
country: France
facility: Centre hospitalier de Saint Omer
city: Laon
country: France
facility: Centre hospitalier de Laon
city: Le Havre
country: France
facility: Centre Hospitalier du Havre
city: Lens
country: France
facility: Centre Hospitalier de Lens
city: Lille
country: France
facility: Centre de radiuothérapie Bourgogne
city: Rang du Fliers
country: France
facility: Centre Hospitalier d'arrondissement de Montreuil sur mer
city: Rouen
country: France
facility: Clinique Mathilde
city: saint Aubin lès Elbeuf
country: France
facility: Centre Hospitalier intercommunal d'Elbeuf-Louvier
city: Saint Aubin sur Scie
country: France
facility: Clinique les Aubépines
city: Saint Martin des Champs
country: France
facility: Clinique de la Baie
city: Saint Quentin
country: France
facility: Clinique Saint Claude
city: Saint Quentin
country: France
facility: Centre hospitalier de Saint Quentin
city: Saint-Omer
country: France
facility: Clinique de Saint-Omer
city: Soissons
country: France
facility: Centre hospitalier de Soissons
city: Tourcoing
country: France
facility: Centre Hospitalier de Tourcoing
city: Valenciennes
country: France
facility: Centre hospitalier de Valenciennes
Study officials:
affiliation: Centre Hospitalier Universitaire Amiens Picardie
name: Jean-Claude BARBARE, MD
role: STUDY_DIRECTOR
References: