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Clinical ResearchERNUNCT02765451

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

A study testing interventions of the Cancéropôle Nord-Ouest in people with Clinical Research and Cancer, run by Centre Hospitalier Universitaire, Amiens at 41 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Clinical Research, Cancer
What is being tested?
interventions of the Cancéropôle Nord-Ouest
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
41 sitesFrance
Study dates
Sep 2015to 21 Feb 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • N/A

Trial locations and contacts

41 sites in 1 country.

41 sites in 1 country

France41 sites

  • Centre hospitalier d'Abbeville

    Abbeville, 80142

  • Clinique de l'Europe

    Amiens, 80000

  • Clinique Victor Pauchet

    Amiens, 80000

  • Hopital Privé d'Arras

    Arras, 62012

  • Centre hospitalier d'Arras

    Arras, 62022

  • Centre de Radiothérapie de la Baie

    Avranches, 50307

  • Centre Hospitalier de Bayeux

    Bayeux, 14400

  • Clinique du Parc Saint Lazare

    Beauvais, 60000

  • Centre hospitalier de Beauvais

    Beauvais, 60021

  • Centre Hospitalier de Béthune

    Béthune, 62408

  • Centre de Radiothérapie Pierre Curie

    Beuvry, 62660

  • Centre Hospitalier de Boulogne sur Mer

    Boulogne-sur-Mer, 62321

  • Centre de Radiothérapie Maurice TUBIANA

    Caen, 14000

  • Polyclinique du Parc

    Caen, 14000

  • Centre hospitalier de Calais

    Calais, 62107

  • Centre Hospitalier de Cherbourg

    Cherbourg, 52102

  • Centre hospitalier Compiègne-Noyon

    Compiègne, 60200

  • Clinique Saint Côme

    Compiègne

  • Clinique de Flandre

    Coudekerque-Branche

  • Centre hospitalier Creil-Senlis

    Creil, 60100

  • Centre Hospitalier de Dunkerque

    Dunkirk, 59385

  • Centre Hospitalier intercommunal Eure-Seine

    Évreux, 27015

  • Centre hospitalier de Flers

    Flers, 61104

  • Centre Hospitalier de Granville

    Granville, 50406

  • Centre Hospitalier d'Hazebrouck

    Hazebrouck, 59524

  • Centre hospitalier de Saint Omer

    Helfaut, 62505

  • Centre hospitalier de Laon

    Laon, 02001

  • Centre Hospitalier du Havre

    Le Havre, 76083

  • Centre Hospitalier de Lens

    Lens, 62307

  • Centre de radiuothérapie Bourgogne

    Lille, 59000

  • Centre Hospitalier d'arrondissement de Montreuil sur mer

    Rang-du-Fliers, 62180

  • Clinique Mathilde

    Rouen, 76175

  • Centre Hospitalier intercommunal d'Elbeuf-Louvier

    Saint-Aubin-lès-Elbeuf, 76503

  • Clinique les Aubépines

    Saint-Aubin-sur-Scie, 76550

  • Clinique de la Baie

    Saint-Martin-des-Champs, 50300

  • Clinique de Saint-Omer

    Saint-Omer, 62575

  • Clinique Saint Claude

    Saint-Quentin, 02100

  • Centre hospitalier de Saint Quentin

    Saint-Quentin, 02321

  • Centre hospitalier de Soissons

    Soissons, 02209

  • Centre Hospitalier de Tourcoing

    Tourcoing, 59208

  • Centre hospitalier de Valenciennes

    Valenciennes, 59300

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
interventions of the Cancéropôle Nord-Ouest
Keywords
non-academic, health institution, development, clinical research, cancer, private hospital, public hospital, northwestern france, france, hospitals
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • interventions of the Cancéropôle Nord-OuestBehavioural

    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,.....

Study groups in NCT02765451
Study groupRoleWhat they receive
A : 1 year of interventionActive comparatorinterventions of Cancéropôle Nord-Ouest during 1 year after an observational period of 2 years.
Receives: Behavioral: interventions of the Cancéropôle Nord-Ouest
B : 2 years of interventionActive comparatorinterventions of Cancéropôle Nord-Ouest during 2 years after an observational period of 1 year.
Receives: Behavioral: interventions of the Cancéropôle Nord-Ouest

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: up to 2 years

Secondary outcomes (1)

  1. 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

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2016 (estimated)
  2. Study startSep 2015
  3. Primary completion15 Nov 2018
  4. Study completion21 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02765451
Sponsor's protocol ID
RNI 2015-05-DR-BARBARE
Acronym
ERNU
Status last verified
Jul 2019
First submitted
27 Apr 2016
Last updated
24 Jul 2019
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing interventions of the Cancéropôle Nord-Ouest in people with Clinical Research and Cancer, run by Centre Hospitalier Universitaire, Amiens at 41 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of inclusions in clinical trials of patients (time frame: up to 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02765451.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2019.

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