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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03572322
Other study ID # 35RC17_8819_ORGAGENE
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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