Clinical and Molecular Evaluation of Childern With Familial Meditterranean Fever and Their Siblings

Not Applicable

• Conditions: Familial Mediterranean Fever

• Registration Number: NCT05488561
• Lead Sponsor: Sohag University

Brief Summary

Familial Mediterranean fever (FMF ,recurrent polyserositis ,periodic disease) is an autosomal recessive auto inflammatory disease which primarily affect population surrounding the Mediterranean basin (Arabs , Turks ,Armenians, Jews ).Despite its striking symptoms pattern FMF was first described as distinct entity only in 1945.

It is characterized by recurrent attacks of fever , peritonitis ,pleurisy , arthritis , or erysipelas like skin disease. The most dangerous complication of this disease is secondary amyloidosis . FMF diagnosis is mainly clinical, and the genetic testing is indicated to support it . Uncommonly, amyloidosis may develop in individuals carrying two Familial Mediterranean fever gene (MEFV ) mutations without overt clinical symptoms of FMF, a condition designated as phenotype II. Furthermore, two MEFV mutations may be harbored without signs or symptoms of FMF nor of reactive amyloidosis. This 'silent' homozygous or compound heterozygote state is termed phenotype III.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-03
• Study First Submitted QC: 2022-08-03
• Last Update Submitted: 2022-08-03
• Study First Posted: 2022-08-04
• Last Update Posted: 2022-08-04
• Study Start: 2022-08-15
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

A- all children diagnosed as FMF according to Tel hashomer criteria aged below 18 years:

The presence of at least 2 of the following 5 criteria after exclusion of other causes can diagnose FMF with high sensitivity:

1. Fever axillary temperature of >38ᵒC, 6-72 h of duration, ≥3 attacks
2. Abdominal pain 6-72 h of duration ≥3 attacks
3. Chest pain 6-72 h duration≥ 3 attacks
4. Arthritis 6-72 h duration ≥3 attacks, oligoarthritis
5. Family history of FMF*(11) B-sisters and brothers of a child with FMF with clinical or subclinical manifestation of FMF.

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Exclusion Criteria

1. Children with other auto inflammatory diseases, or with other diseases.
2. Persons above 18 years old.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
FMF gene	12 month	positive or negative
CBC	12 month	leucocytosis
amyloid level	12 month	high in untreated patients

Trial Locations

Locations (1)

Sohag University Hospital; 🇪🇬 Sohag, Egypt