Life Quality Study for PFAPA Patient (PFAPA)
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| ClinicalTrials.gov Identifier: NCT02811705 |
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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
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Sponsor:
Versailles Hospital
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 |
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 |
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 |
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| 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
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status | Unknown status | ||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 | ||