Genetics Tests : How to Improve Management Within Two Medical Specialities (ORGAGENE)

April 18, 2023 updated by: Rennes University Hospital
This survey will assess discrepancies between official clinical genetics guidelines and practices within 3 West regions of France.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Genetic tests are now widely used in medicine whatever specialities or ages. However genetic tests are not common biological exams as they may either reveal genetic anomalies before any signs (presymptomatic diagnosis) or handle the gene pool of an entire family but not only one patient. Due to these specific managements, genetics tests have required specific laws for nearly 20 years in France.

The French 2011 Bioethics Law (and its decree in 2013) especially issues involving genetic tests now establishes purposes for which genetic data can be disclosed and switch for patient civil responsibility towards his family. This patient has no longer choice and the medical confidentiality might now be breached.

Although specific guidelines practices have been spread by officials, the gap between recommendations and uses tend probably to be huge especially from non-geneticist physicians.

This survey will assess discrepancies between official clinical genetics guidelines and practices within 3 West regions of France.

20 focus groups are intended to be lead with neurologists and oncologists working in hospitals as theses physicians face different genetic issues daily.

20 interviews are scheduled with patients. The investigators aim at collecting information from medical, legal and sociological points of view in order to better understand these gaps.

This will be the first attempt to gather and understand medical practices in the genetic tests area. This could be useful to adapt courses in medical school and along professional life and how to spread them for a deep impact.

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

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

Study Contact

Study Contact Backup

  • Name: Direction de la Recherche et de l'Innovation
  • Phone Number: 33 2 99 28 25 55
  • Email: drc@chu-rennes.fr

Study Locations

  • France
      • Rennes, France, 35 033
        • CHU de Rennes

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

genetics tests

Description

Inclusion Criteria:

  • Specialists in Oncology, Endocrinology, Neurology and Medical Genetics
  • Doctors who have already received and returned genetics tests results
  • Main hospital exercise (CHU, CH, CRLCC) on the territory of the HUGO interregion regrouping the administrative regions Bretagne, Pays-de-Loire and Centre
  • Adults who having benefited genetics tests
  • Ability to express oneself easily in French and whose clinical situation allows it

Exclusion Criteria:

  • liberal doctor
  • Patient refusing to participated in the study
  • Medical contraindication

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients
Other: Interviews
Interviews
Doctors
Other: Focus Group
Focus Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Characteristics of the determining factors
Time Frame: through study completion, an average of 1 year
Characteristics of the determining factors (medical, sociological, ethical and legal) in the medical practices during the implementation of an ECGP
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Rennes University Hospital

Collaborators

Université de Caen Normandie
IMT Atlantique Nantes - France
Université Rennes 1 - France

Investigators

  • Study Director: Laurent Pasquier, MD, Rennes University Hospital

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 (Actual)

September 18, 2017

Primary Completion (Actual)

April 13, 2022

Study Completion (Actual)

April 13, 2022

Study Registration Dates

First Submitted

June 18, 2018

First Submitted That Met QC Criteria

June 18, 2018

First Posted (Actual)

June 28, 2018

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 18, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 35RC17_8819_ORGAGENE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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