GeneticsORGAGENENCT03572322
Genetics Tests : How to Improve Management Within Two Medical Specialities
An observational study of Genetics and Diagnostic Techniques and Procedures, run by Rennes University Hospital at 1 site in France.
Trial summary
This survey will assess discrepancies between official clinical genetics guidelines and practices within 3 West regions of France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Genetics, Diagnostic Techniques and Procedures
- What is being tested?
- Focus Group and Interviews
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2017to 13 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: genetics tests
Who may be able to join
- 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
Who cannot join
- liberal doctor
- Patient refusing to participated in the study
- Medical contraindication
Trial locations and contacts
1 site in 1 country.
About this study
This survey will assess discrepancies between official clinical genetics guidelines and practices within 3 West regions of France.
Read the 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.
- Conditions
- Genetics, Diagnostic Techniques and Procedures
- Being tested
- Focus Group, Interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Focus GroupOther
Focus Group
InterviewsOther
Interviews
| Study group | Role | What they receive |
|---|---|---|
| Doctors | Not described Receives: Other: Focus Group | |
| Patients | Not described Receives: Other: Interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2018
- Study start18 Sep 2017
- Primary completion13 Apr 2022
- Study completion13 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GeneticsStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- IMT Atlantique Nantes - France, Université de Caen Normandie, University of Rennes
- Responsible party
- Sponsor
- Investigators
- Laurent Pasquier, MD, Study director, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03572322
- Sponsor's protocol ID
- 35RC17_8819_ORGAGENE
- Acronym
- ORGAGENE
- Status last verified
- Apr 2023
- First submitted
- 18 Jun 2018
- Last updated
- 19 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics Tests : How to Improve Management Within Two Medical Specialities
- ClinicalTrials.gov ID
- NCT03572322
- Acronym / sponsor ID
- ORGAGENE / 35RC17_8819_ORGAGENE
- Conditions
- Genetics, Diagnostic Techniques and Procedures
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- IMT Atlantique Nantes - France, Université de Caen Normandie, University of Rennes
- Study start
- 18 Sep 2017 (actual)
- Primary completion
- 13 Apr 2022 (actual)
- Study completion
- 13 Apr 2022 (actual)
- First posted
- 28 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Doctors | – | Other: Focus Group |
| Patients | – | Other: Interviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- genetics tests
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- liberal doctor
- Patient refusing to participated in the study
- Medical contraindication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Focus GroupFocus Group | Other | Doctors |
| InterviewsInterviews | Other | Patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent Pasquier, MD study director
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Genetics and Diagnostic Techniques and Procedures, run by Rennes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characteristics of the determining factors (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.