Genetics Tests : How to Improve Management Within Two Medical Specialities

Genetics Clinical Trial

— ORGAGENE  

Official title:

Genetics Tests : How to Improve Management Within Two Medical Specialities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03572322
• Other study ID #: 35RC17_8819_ORGAGENE
• Status: Completed
• Start date: September 18, 2017
• Est. completion date: April 13, 2022

Study information

• Verified date: April 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 13, 2022
• Est. primary completion date: April 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diagnostic Techniques and Procedures
• Genetics

Intervention

Other:
• Focus Group
Focus Group
• Interviews
Interviews

Locations

Country	Name	City	State
France	CHU de Rennes	Rennes

Sponsors (4)

Lead Sponsor	Collaborator
Rennes University Hospital	IMT Atlantique Nantes - France, Université de Caen Normandie, Université Rennes 1 - France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Characteristics of the determining factors	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