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

Cancer Clinical Trial

— ERNU  

Official title:

Randomized Trial Evaluating Intervention of the Cancéropôle Nord-Ouest in the Development of Clinical Research in Non-Academic Health Institutions (ERNU)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02765451
• Other study ID #: RNI 2015-05-DR-BARBARE
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: February 21, 2019

Study information

• Verified date: July 2019
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 21, 2019
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Clinical Research

Intervention

Behavioral:
• 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,.....

Locations

Country	Name	City	State
France	Centre hospitalier d'Abbeville	Abbeville
France	Clinique de l'Europe	Amiens
France	Clinique Victor Pauchet	Amiens
France	Centre hospitalier d'Arras	Arras
France	Hopital Privé d'Arras	Arras
France	Centre de Radiothérapie de la Baie	Avranches
France	Centre Hospitalier de Bayeux	Bayeux
France	Centre hospitalier de Beauvais	Beauvais
France	Clinique du Parc Saint Lazare	Beauvais
France	Centre Hospitalier de Béthune	Béthune
France	Centre de Radiothérapie Pierre Curie	Beuvry
France	Centre Hospitalier de Boulogne sur Mer	Boulogne sur Mer
France	Centre de Radiothérapie Maurice TUBIANA	Caen
France	Polyclinique du Parc	Caen
France	Centre hospitalier de Calais	Calais
France	Centre Hospitalier de Cherbourg	Cherbourg
France	Centre hospitalier Compiègne-Noyon	Compiègne
France	Clinique Saint Côme	Compiègne
France	Clinique de Flandre	Coudekerque Branche
France	Centre hospitalier Creil-Senlis	Creil
France	Centre Hospitalier de Dunkerque	Dunkerque
France	Centre Hospitalier intercommunal Eure-Seine	Evreux
France	Centre hospitalier de Flers	Flers
France	Centre Hospitalier de Granville	Granville
France	Centre Hospitalier d'Hazebrouck	Hazebrouck
France	Centre hospitalier de Saint Omer	Helfaut
France	Centre hospitalier de Laon	Laon
France	Centre Hospitalier du Havre	Le Havre
France	Centre Hospitalier de Lens	Lens
France	Centre de radiuothérapie Bourgogne	Lille
France	Centre Hospitalier d'arrondissement de Montreuil sur mer	Rang du Fliers
France	Clinique Mathilde	Rouen
France	Centre Hospitalier intercommunal d'Elbeuf-Louvier	saint Aubin lès Elbeuf
France	Clinique les Aubépines	Saint Aubin sur Scie
France	Clinique de la Baie	Saint Martin des Champs
France	Centre hospitalier de Saint Quentin	Saint Quentin
France	Clinique Saint Claude	Saint Quentin
France	Clinique de Saint-Omer	Saint-Omer
France	Centre hospitalier de Soissons	Soissons
France	Centre Hospitalier de Tourcoing	Tourcoing
France	Centre hospitalier de Valenciennes	Valenciennes

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens	Centre de traitement des données du Cancéropôle Nord-Ouest, Centre F. BACLESSE, Caen, France, Institut National de la Santé et de la Recherche Médical (INSERM) 1086 (Pr Guy LAUNOY) Centre F. BACLESSE, Caen, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of inclusions in clinical trials of patients	Measure the increase in inclusions in clinical trials of patients attending a Hospital or a private clinic "authorized to treat cancer" associated with a support provided by the Cancéropôle Nord-Ouest	up to 2 years
Secondary	Reduction of social inequalities recruitment in clinical trials associated with the intervention of the Cancéropôle Nord-Ouest	assessment of the average of the reduction of social inequalities recruitment in clinical trial before and after the intervention of the Cancéropöle Nord-Ouest in each centers and in global. the social inequalities are calculated with the social and demographic tool developped by the french national institute of statistic and economic studies	up to 2 years