Study Evaluating Intervention in the Development of Clinical Research in Non-Academic Health Institution (ERNU)
ERNU
Randomized Trial Evaluating Intervention of the Cancéropôle Nord-Ouest in the Development of Clinical Research in Non-Academic Health Institutions (ERNU)
1 other identifier
interventional
40
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2015
Longer than P75 for not_applicable
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2015
CompletedFirst Submitted
Initial submission to the registry
April 27, 2016
CompletedFirst Posted
Study publicly available on registry
May 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2019
CompletedJuly 24, 2019
July 1, 2019
3.2 years
April 27, 2016
July 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Reduction of social inequalities recruitment in clinical trials associated with the intervention of the Cancéropôle Nord-Ouest
up to 2 years
Study Arms (2)
A : 1 year of intervention
ACTIVE COMPARATORinterventions of Cancéropôle Nord-Ouest during 1 year after an observational period of 2 years.
B : 2 years of intervention
ACTIVE COMPARATORinterventions of Cancéropôle Nord-Ouest during 2 years after an observational period of 1 year.
Interventions
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,.....
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- N/A
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (41)
Centre hospitalier d'Abbeville
Abbeville, 80142, France
Clinique de l'Europe
Amiens, 80000, France
Clinique Victor Pauchet
Amiens, 80000, France
Hopital Privé d'Arras
Arras, 62012, France
Centre hospitalier d'Arras
Arras, 62022, France
Centre de Radiothérapie de la Baie
Avranches, 50307, France
Centre Hospitalier de Bayeux
Bayeux, 14400, France
Clinique du Parc Saint Lazare
Beauvais, 60000, France
Centre hospitalier de Beauvais
Beauvais, 60021, France
Centre de Radiothérapie Pierre Curie
Beuvry, 62660, France
Centre Hospitalier de Béthune
Béthune, 62408, France
Centre Hospitalier de Boulogne sur Mer
Boulogne-sur-Mer, 62321, France
Centre de Radiothérapie Maurice TUBIANA
Caen, 14000, France
Polyclinique du Parc
Caen, 14000, France
Centre hospitalier de Calais
Calais, 62107, France
Centre Hospitalier de Cherbourg
Cherbourg, 52102, France
Centre hospitalier Compiègne-Noyon
Compiègne, 60200, France
Clinique Saint Côme
Compiègne, France
Clinique de Flandre
Coudekerque-Branche, France
Centre hospitalier Creil-Senlis
Creil, 60100, France
Centre Hospitalier de Dunkerque
Dunkirk, 59385, France
Centre Hospitalier intercommunal Eure-Seine
Évreux, 27015, France
Centre hospitalier de Flers
Flers, 61104, France
Centre Hospitalier de Granville
Granville, 50406, France
Centre Hospitalier d'Hazebrouck
Hazebrouck, 59524, France
Centre hospitalier de Saint Omer
Helfaut, 62505, France
Centre hospitalier de Laon
Laon, 02001, France
Centre Hospitalier du Havre
Le Havre, 76083, France
Centre Hospitalier de Lens
Lens, 62307, France
Centre de radiuothérapie Bourgogne
Lille, 59000, France
Centre Hospitalier d'arrondissement de Montreuil sur mer
Rang-du-Fliers, 62180, France
Clinique Mathilde
Rouen, 76175, France
Centre Hospitalier intercommunal d'Elbeuf-Louvier
Saint-Aubin-lès-Elbeuf, 76503, France
Clinique les Aubépines
Saint-Aubin-sur-Scie, 76550, France
Clinique de la Baie
Saint-Martin-des-Champs, 50300, France
Clinique de Saint-Omer
Saint-Omer, 62575, France
Clinique Saint Claude
Saint-Quentin, 02100, France
Centre hospitalier de Saint Quentin
Saint-Quentin, 02321, France
Centre hospitalier de Soissons
Soissons, 02209, France
Centre Hospitalier de Tourcoing
Tourcoing, 59208, France
Centre hospitalier de Valenciennes
Valenciennes, 59300, France
MeSH Terms
Conditions
Study Officials
- STUDY DIRECTOR
Jean-Claude BARBARE, MD
Centre Hospitalier Universitaire Amiens Picardie
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2016
First Posted
May 6, 2016
Study Start
September 1, 2015
Primary Completion
November 15, 2018
Study Completion
February 21, 2019
Last Updated
July 24, 2019
Record last verified: 2019-07