Familial Mediterranean FeverSport & FMFNCT06257342
Physical Abilities of Teenagers With Familial Mediterranean Fever
An observational study of Familial Mediterranean Fever, run by Véronique Hentgen at 1 site in France.
Trial summary
Physical abilities of teenagers with familial Mediterranean fever Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Familial Mediterranean Fever
- What is being tested?
- 6 minutes walk
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Teenagers with familian mediteranean fever
Who may be able to join
- Patients with a clinical diagnosis of FMF according to the Tel-Hashomer criteria for whom a sports evaluation was offered during their bridging program
- Age >12
- Followed or having been followed in the pediatric department of the CH of Versailles
- No opposition of the patient and his/her parent/legal guardian in case of a minor patient
Who cannot join
- Expressed refusal of the patient and his/her parent/legal guardian to participate in the study and/or to use genetic data for research purposes
Trial locations and contacts
1 site in 1 country.
About this study
Physical abilities of teenagers with familial Mediterranean fever
Read the detailed description
Physical abilities of teenagers with familial Mediterranean fever by describing the maximum oxygen consumption (VO2max) estimated from a 6-minute walk test
- Conditions
- Familial Mediterranean Fever
- Being tested
- 6 minutes walk
- Medical subject headings
- Familial Mediterranean Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 minutes walkProcedure or surgery
A 6 minutes walk test
What is being measured
The primary outcome is the main question the study is designed to answer.
the maximum oxygen consumption (VO2max) estimated from the 6-minute walk test
Describe the maximum oxygen consumption (VO2max) estimated from the 6-minute walk test
Measured: 6 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start30 Jul 2023
- Primary completion15 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean FeverStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Véronique Hentgen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Véronique Hentgen, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06257342
- Sponsor's protocol ID
- P23/04
- Acronym
- Sport & FMF
- Status last verified
- Jun 2023
- First submitted
- 6 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Abilities of Teenagers With Familial Mediterranean Fever
- ClinicalTrials.gov ID
- NCT06257342
- Acronym / sponsor ID
- Sport & FMF / P23/04
- Conditions
- Familial Mediterranean Fever
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Véronique HentgenUniversity, hospital or other
- Study start
- 30 Jul 2023 (actual)
- Primary completion
- 15 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 13 Feb 2024 (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.
Physical abilities of teenagers with familial Mediterranean fever
Detailed description
Physical abilities of teenagers with familial Mediterranean fever by describing the maximum oxygen consumption (VO2max) estimated from a 6-minute walk test
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Teenagers with familian mediteranean fever
Key inclusion criteria (4 listed)
- Patients with a clinical diagnosis of FMF according to the Tel-Hashomer criteria for whom a sports evaluation was offered during their bridging program
- Age >12
- Followed or having been followed in the pediatric department of the CH of Versailles
- No opposition of the patient and his/her parent/legal guardian in case of a minor patient
Key exclusion criteria (1 listed)
- Expressed refusal of the patient and his/her parent/legal guardian to participate in the study and/or to use genetic data for research purposes
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 |
|---|---|---|
| 6 minutes walkA 6 minutes walk test | Procedure or surgery | – |
Primary outcome
the maximum oxygen consumption (VO2max) estimated from the 6-minute walk test
Time frame: 6 minutes
Describe the maximum oxygen consumption (VO2max) estimated from the 6-minute walk test
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Familial Mediterranean Fever, run by Véronique Hentgen 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 4 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: under way, not looking for participants, as of the sponsor's last update on 13 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
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?
the maximum oxygen consumption (VO2max) estimated from the 6-minute walk test (time frame: 6 minutes). 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 13 Feb 2024.