PFAPA SyndromePFAPANCT02811705
Life Quality Study for PFAPA Patient
An observational study of PFAPA Syndrome, run by Versailles Hospital at 2 sites in France.
Trial summary
This cohort study aims to assess the quality of life (or welfare) related to the health of children and adolescents with an non genetics auto-inflammatory disease PFAPA or Marshall syndrome to compare it to children or adolescents with recurrent fever genetics of Familial Mediterranean fever (FMF) in order to improve… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- PFAPA Syndrome
- What is being tested?
- Quality of life
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2015to Apr 2017
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with PFAPA syndrome compare to patient with FMF syndrome
Who may be able to join
- PFAPA syndrome patients or FMF patients
Who cannot join
- Participation refusal
Trial locations and contacts
2 sites in 1 country.
About this study
This cohort study aims to assess the quality of life (or welfare) related to the health of children and adolescents with an non genetics auto-inflammatory disease PFAPA or Marshall syndrome to compare it to children or adolescents with recurrent fever genetics of Familial Mediterranean fever (FMF) in order to improve their overall care.
- Conditions
- PFAPA Syndrome
- Being tested
- Quality of life
- Medical subject headings
- Marshall syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quality of lifeOther
Quality of life
| Study group | Role | What they receive |
|---|---|---|
| PFAPA group | Life quality for PFAPA patient report by themselves or parent Receives: Other: Quality of life | |
| FMF group | Life quality for FMF patient report by themselves or parent Receives: Other: Quality of life |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare quality of life from patients with PFAPA and FMF, reported by parents and by patients themselves
Measured: 1 day
Secondary outcomes (1)
Evaluate the fatigue status of patients through questionnaire PedsQL TM 3.0 multidimensional scale tiredness
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PFAPA SyndromeStudies 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
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Véronique Hentgen, Versailles Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02811705
- Sponsor's protocol ID
- P15/13_PFAPA
- Acronym
- PFAPA
- Status last verified
- Feb 2023
- First submitted
- 15 Jun 2016
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life Quality Study for PFAPA Patient
- ClinicalTrials.gov ID
- NCT02811705
- Acronym / sponsor ID
- PFAPA / P15/13_PFAPA
- Conditions
- PFAPA Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 23 Jun 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.
This cohort study aims to assess the quality of life (or welfare) related to the health of children and adolescents with an non genetics auto-inflammatory disease PFAPA or Marshall syndrome to compare it to children or adolescents with recurrent fever genetics of Familial Mediterranean fever (FMF) in order to improve their overall care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PFAPA group | – | Other: Quality of lifeLife quality for PFAPA patient report by themselves or parent |
| FMF group | – | Other: Quality of lifeLife quality for FMF patient report by themselves or parent |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with PFAPA syndrome compare to patient with FMF syndrome
Key inclusion criteria (1 listed)
- PFAPA syndrome patients or FMF patients
Key exclusion criteria (1 listed)
- Participation refusal
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 |
|---|---|---|
| Quality of lifeQuality of life | Other | FMF group, PFAPA group |
Primary outcome
Compare quality of life from patients with PFAPA and FMF, reported by parents and by patients themselves
Time frame: 1 day
1 secondary outcome
Evaluate the fatigue status of patients through questionnaire PedsQL TM 3.0 multidimensional scale tiredness
Time frame: 1 day
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 8 Feb 2023.
Related trials for PFAPA Syndrome
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Efficacy and Safety of Thalidomide for Pediatric PFAPA Syndrome
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AutoInflammatory Disease Alliance Registry (AIDA)
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of PFAPA Syndrome, run by Versailles Hospital at 2 sites 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 1 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 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Compare quality of life from patients with PFAPA and FMF, reported by parents and by patients themselves (time frame: 1 day). 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 8 Feb 2023.