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Life Quality Study for PFAPA Patient (PFAPA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02811705
Recruitment Status : Unknown
Verified June 2016 by Véronique Hentgen, Versailles Hospital.
Recruitment status was:  Recruiting
First Posted : June 23, 2016
Last Update Posted : June 23, 2016
Sponsor:
Information provided by (Responsible Party):
Véronique Hentgen, Versailles Hospital

Tracking Information
First Submitted Date June 15, 2016
First Posted Date June 23, 2016
Last Update Posted Date June 23, 2016
Study Start Date July 2015
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 22, 2016)
Compare quality of life from patients with PFAPA and FMF, reported by parents and by patients themselves [ Time Frame: 1 day ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 22, 2016)
Evaluate the fatigue status of patients through questionnaire PedsQL TM 3.0 multidimensional scale tiredness [ Time Frame: 1 day ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Life Quality Study for PFAPA Patient
Official Title Not Provided
Brief 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 their overall care.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with PFAPA syndrome compare to patient with FMF syndrome
Condition PFAPA Syndrome
Intervention Other: Quality of life
Quality of life
Study Groups/Cohorts
  • PFAPA group
    Life quality for PFAPA patient report by themselves or parent
    Intervention: Other: Quality of life
  • FMF group
    Life quality for FMF patient report by themselves or parent
    Intervention: Other: Quality of life
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 22, 2016)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2017
Estimated Primary Completion Date July 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • PFAPA syndrome patients or FMF patients

Exclusion Criteria:

  • Participation refusal
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02811705
Other Study ID Numbers P15/13_PFAPA
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Véronique Hentgen, Versailles Hospital
Study Sponsor Versailles Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Versailles Hospital
Verification Date June 2016