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

NCT ID: NCT05488561

Last Updated: 2022-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-15

Study Completion Date

2023-08-31

Brief Summary

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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

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Conditions

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Familial Mediterranean Fever

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Interventions

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CBC with differential ,ESR ,CRP, Amyloid level , FMF gene

leucocytosis , high ESR and CRP ,amyloid level indicates inflammation positive FMF gene indicates having the disease .

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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liver and kidney function tests

Eligibility Criteria

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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.

Exclusion Criteria

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

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Nahla Abdelziz Fawy

resident doctor at pediatric department at faculty of medicine sohag university hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Sohag University Hospital

Sohag, , Egypt

Site Status

Countries

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Egypt

Central Contacts

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nahla a fawy, resident

Role: CONTACT

01015681398

ashraf m redwan, assisstant professor

Role: CONTACT

Facility Contacts

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Osama R Elshrif, professor

Role: primary

References

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Alghamdi M. Familial Mediterranean fever, review of the literature. Clin Rheumatol. 2017 Aug;36(8):1707-1713. doi: 10.1007/s10067-017-3715-5. Epub 2017 Jun 18.

Reference Type BACKGROUND
PMID: 28624931 (View on PubMed)

Cakan M, Karadag SG, Tanatar A, Sonmez HE, Ayaz NA. The Value of Serum Amyloid A Levels in Familial Mediterranean Fever to Identify Occult Inflammation During Asymptomatic Periods. J Clin Rheumatol. 2021 Jan 1;27(1):1-4. doi: 10.1097/RHU.0000000000001134.

Reference Type BACKGROUND
PMID: 31524848 (View on PubMed)

Ozdogan H, Ugurlu S. Familial Mediterranean Fever. Presse Med. 2019 Feb;48(1 Pt 2):e61-e76. doi: 10.1016/j.lpm.2018.08.014. Epub 2019 Jan 25.

Reference Type BACKGROUND
PMID: 30686512 (View on PubMed)

Talaat HS, Sheba MF, Mohammed RH, Gomaa MA, Rifaei NE, Ibrahim MFM. Genotype Mutations in Egyptian Children with Familial Mediterranean Fever: Clinical Profile, and Response to Colchicine. Mediterr J Rheumatol. 2020 Jun 15;31(2):206-213. doi: 10.31138/mjr.31.2.206. eCollection 2020 Jun.

Reference Type BACKGROUND
PMID: 32676558 (View on PubMed)

Other Identifiers

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Soh_Med_22_07_20

Identifier Type: -

Identifier Source: org_study_id

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