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

July 23, 2019 updated by: Centre Hospitalier Universitaire, Amiens

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France, 80142
        • Centre Hospitalier d'Abbeville
      • Amiens, France, 80000
        • Clinique de l'Europe
      • Amiens, France, 80000
        • Clinique Victor Pauchet
      • Arras, France, 62022
        • Centre Hospitalier d'Arras
      • Arras, France, 62012
        • Hopital Privé d'Arras
      • Avranches, France, 50307
        • Centre de radiothérapie de la Baie
      • Bayeux, France, 14400
        • Centre Hospitalier de Bayeux
      • Beauvais, France, 60021
        • Centre Hospitalier de Beauvais
      • Beauvais, France, 60000
        • Clinique du Parc Saint Lazare
      • Beuvry, France, 62660
        • Centre de Radiotherapie Pierre Curie
      • Boulogne sur Mer, France, 62321
        • Centre Hospitalier de Boulogne Sur Mer
      • Béthune, France, 62408
        • Centre Hospitalier de Béthune
      • Caen, France, 14000
        • Centre de Radiothérapie Maurice TUBIANA
      • Caen, France, 14000
        • Polyclinique du Parc
      • Calais, France, 62107
        • Centre hospitalier de Calais
      • Cherbourg, France, 52102
        • Centre Hospitalier de Cherbourg
      • Compiègne, France, 60200
        • Centre Hospitalier Compiègne-Noyon
      • Compiègne, France
        • Clinique Saint Come
      • Coudekerque Branche, France
        • Clinique de Flandre
      • Creil, France, 60100
        • Centre hospitalier Creil-Senlis
      • Dunkerque, France, 59385
        • Centre Hospitalier de Dunkerque
      • Evreux, France, 27015
        • Centre Hospitalier intercommunal Eure-Seine
      • Flers, France, 61104
        • Centre Hospitalier de Flers
      • Granville, France, 50406
        • Centre Hospitalier de Granville
      • Hazebrouck, France, 59524
        • Centre Hospitalier d'Hazebrouck
      • Helfaut, France, 62505
        • Centre Hospitalier de Saint Omer
      • Laon, France, 02001
        • Centre Hospitalier de Laon
      • Le Havre, France, 76083
        • Centre Hospitalier du Havre
      • Lens, France, 62307
        • Centre Hospitalier de LENS
      • Lille, France, 59000
        • Centre de radiuothérapie Bourgogne
      • Rang du Fliers, France, 62180
        • Centre Hospitalier d'arrondissement de Montreuil sur mer
      • Rouen, France, 76175
        • Clinique Mathilde
      • Saint Aubin sur Scie, France, 76550
        • Clinique les Aubépines
      • Saint Martin des Champs, France, 50300
        • Clinique de la Baie
      • Saint Quentin, France, 02321
        • Centre Hospitalier de Saint Quentin
      • Saint Quentin, France, 02100
        • Clinique Saint Claude
      • Saint-Omer, France, 62575
        • Clinique de Saint-Omer
      • Soissons, France, 02209
        • Centre Hospitalier de Soissons
      • Tourcoing, France, 59208
        • Centre Hospitalier de Tourcoing
      • Valenciennes, France, 59300
        • Centre hospitalier de valenciennes
      • saint Aubin lès Elbeuf, France, 76503
        • Centre Hospitalier intercommunal d'Elbeuf-Louvier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A : 1 year of intervention
interventions of Cancéropôle Nord-Ouest during 1 year after an observational period of 2 years.
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,.....
ACTIVE_COMPARATOR: B : 2 years of intervention
interventions of Cancéropôle Nord-Ouest during 2 years after an observational period of 1 year.
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,.....

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of inclusions in clinical trials of patients
Time Frame: up to 2 years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of social inequalities recruitment in clinical trials associated with the intervention of the Cancéropôle Nord-Ouest
Time Frame: up to 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Collaborators

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

Investigators

  • Study Director: Jean-Claude BARBARE, MD, Centre Hospitalier Universitaire Amiens-Picardie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

November 15, 2018

Study Completion (ACTUAL)

February 21, 2019

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (ESTIMATE)

May 6, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RNI 2015-05-DR-BARBARE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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