Life Quality Study for PFAPA Patient | NCT02811705

Studies
Life Quality Study for PFAPA Patient

NCT02811705

Sponsor

Versailles Hospital

Status

Completed

Last Update Posted

Feb 8, 2023Actual

Enrollment

60Actual

Phase

Not provided

Conditions

PFAPA Syndrome

Interventions

Quality of life

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Dec 2016Actual

Completion Date

Apr 2017Actual

First Submitted Date

Jun 15, 2016

First Submission Date that Met QC Criteria

Jun 22, 2016

First Posted Date

Jun 23, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2023

Last Update Posted Date

Feb 8, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
PFAPA group		Life quality for PFAPA patient report by themselves or parent	Other: Quality of life
FMF group		Life quality for FMF patient report by themselves or parent	Other: Quality of life

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Quality of life	Other	Quality of life	FMF group PFAPA group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Compare quality of life from patients with PFAPA and FMF, reported by parents and by patients themselves		1 day

Secondary Outcomes

Measure	Description	Time Frame
Evaluate the fatigue status of patients through questionnaire PedsQL TM 3.0 multidimensional scale tiredness		1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PFAPA syndrome patients or FMF patients

Exclusion Criteria:

Participation refusal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Patients with PFAPA syndrome compare to patient with FMF syndrome

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre hospitalier de Versailles		Le Chesnay			France
CH de Bicètre

Condition Browse Module

MeSH Terms

ID	Term
C536025	Marshall syndrome

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011788	Quality of Life

Ancestor Terms

ID	Term
D006304	Health Status
D003710	Demography
D015991	Epidemiologic Measurements
D011634	Public Health

Browse Leaves

Not provided

Browse Branches

Not provided