Genetic SyndromeGOSSERNCT02704260
Genetic of SportS Induced Endofibrotic Remodeling
A study testing GENETIC ANALYSIS in people with Genetic Syndrome, run by University Hospital, Angers at 1 site in France.
Trial summary
search for a genetic cause of vascular endofibrose Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Genetic Syndrome
- What is being tested?
- GENETIC ANALYSIS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 2 Mar 2016to 2 Sep 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- High level reached Cyclists vascular endofibrose
- Cyclist high level and not sick with a brother or sister is senior cyclist reaches the vascular endofibrose.
Who cannot join
- not obtaining consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endofibrose Vasculaire et génétique
search for a genetic cause of vascular endofibrose
Read the detailed description
Perform a DNA analysis to mark the existence of mutations in one or more genes encoding proteins involved in vascular remodeling high.
5 patients or relatives of patients topics
- Conditions
- Genetic Syndrome
- Being tested
- GENETIC ANALYSIS
- Medical subject headings
- Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GENETIC ANALYSISGenetic
prélevement blood to search for a genetic cause of vascular endofibrose. Search genetic mutations in 5 subjects.
| Study group | Role | What they receive |
|---|---|---|
| GENETIC ANALISYS | Experimental | GENETIC ANALYSIS AND RESEARCH OF GENETIC BLOOD SAMPLE Receives: Genetic: GENETIC ANALYSIS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of mutations or nucleotides variations
DNA analysis and search for genetic mutations
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study start2 Mar 2016
- Primary completion2 Sep 2016
- Study completion2 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Genetic SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- PIERRE ABRAHAM, PROFESSOR, Principal investigator, UH ANGERS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704260
- Sponsor's protocol ID
- 2015-A00441-48
- Acronym
- GOSSER
- Status last verified
- Dec 2016
- First submitted
- 23 Feb 2016
- Last updated
- 1 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endofibrose Vasculaire et génétique
- ClinicalTrials.gov ID
- NCT02704260
- Acronym / sponsor ID
- GOSSER / 2015-A00441-48
- Conditions
- Genetic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 2 Mar 2016 (actual)
- Primary completion
- 2 Sep 2016 (actual)
- Study completion
- 2 Sep 2016 (actual)
- First posted
- 9 Mar 2016 (estimated)
- 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.
search for a genetic cause of vascular endofibrose
Detailed description
Perform a DNA analysis to mark the existence of mutations in one or more genes encoding proteins involved in vascular remodeling high.
5 patients or relatives of patients topics
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GENETIC ANALISYS | Experimental | Genetic: GENETIC ANALYSISGENETIC ANALYSIS AND RESEARCH OF GENETIC BLOOD SAMPLE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- High level reached Cyclists vascular endofibrose
- Cyclist high level and not sick with a brother or sister is senior cyclist reaches the vascular endofibrose.
Key exclusion criteria (1 listed)
- not obtaining consent
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 |
|---|---|---|
| GENETIC ANALYSISprélevement blood to search for a genetic cause of vascular endofibrose. Search genetic mutations in 5 subjects. | Genetic | GENETIC ANALISYS |
Primary outcome
Presence of mutations or nucleotides variations
Time frame: 1 hour
DNA analysis and search for genetic mutations
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 1 Nov 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Genetic Syndrome
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
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.
PIERRE ABRAHAM, PROFESSOR principal investigator
UH ANGERS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GENETIC ANALYSIS in people with Genetic Syndrome, run by University Hospital, Angers 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 2 inclusion and 1 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 1 Nov 2017. 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?
Presence of mutations or nucleotides variations (time frame: 1 hour). 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 1 Nov 2017.