Genetics Tests : How to Improve Management Within Two Med... | NCT03572322

Studies
Genetics Tests : How to Improve Management Within Two Medical Specialities

NCT03572322

Sponsor

Rennes University Hospital

Status

Completed

Last Update Posted

Apr 19, 2023Actual

Enrollment

36Actual

Phase

Not provided

Conditions

Genetics
Diagnostic Techniques and Procedures

Interventions

Focus Group
Interviews

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 18, 2017Actual

Primary Completion Date

Apr 13, 2022Actual

Completion Date

Apr 13, 2022Actual

First Submitted Date

Jun 18, 2018

First Submission Date that Met QC Criteria

Jun 18, 2018

First Posted Date

Jun 28, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2023

Last Update Posted Date

Apr 19, 2023Actual

Name	Class
IMT Atlantique Nantes - France	UNKNOWN
Université de Caen Normandie	OTHER
University of Rennes	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Doctors			Other: Focus Group
Patients			Other: Interviews

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Focus Group	Other	Focus Group	Doctors
Interviews

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

genetics tests

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Laurent Pasquier, MD	Rennes University Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Rennes		Rennes		35 033	France

Intervention Browse Module

MeSH Terms

ID	Term
D017144	Focus Groups
D007407	Interviews as Topic

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided