Genetics Tests : How to Improve Managem… | Clinical Trial

Key information

Conditions

Genetics Diagnostic Techniques and Procedures

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Rennes

Rennes, 35 033, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Focus Group

Other

Focus Group

Interviews

Other

Interviews

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Collaborators

IMT Atlantique Nantes - France
University of Rennes
Université de Caen Normandie

Registry information

Acronym: ORGAGENE

Important dates

Study start: 2017
Primary completion: 2022
Study completion: 2022
First posted: Jun 28, 2018
Registry last updated: Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed