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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Universitaire, Amiens

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 21, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 6, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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