Back to resultsClinical and Molecular Evaluation of Childern With Familial Meditterranean Fever and Their Siblings
Primary Purpose
Familial Mediterranean Fever
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
CBC with differential ,ESR ,CRP, Amyloid level , FMF gene
Sponsored by
About this trial
This is an interventional screening trial for Familial Mediterranean Fever
Eligibility Criteria
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:
- Fever axillary temperature of >38ᵒC, 6-72 h of duration, ≥3 attacks
- Abdominal pain 6-72 h of duration ≥3 attacks
- Chest pain 6-72 h duration≥ 3 attacks
- Arthritis 6-72 h duration ≥3 attacks, oligoarthritis
- Family history of FMF*(11) B-sisters and brothers of a child with FMF with clinical or subclinical manifestation of FMF.
Exclusion Criteria:
- Children with other auto inflammatory diseases, or with other diseases.
- Persons above 18 years old.
Sites / Locations
- Sohag University Hospital
Outcomes
Primary Outcome Measures
CBC
leucocytosis
amyloid level
high in untreated patients
FMF gene
positive or negative
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05488561
Brief Title
Clinical and Molecular Evaluation of Childern With Familial Meditterranean Fever and Their Siblings
Official Title
Clinical and Molecular Evaluation of Childern With Familial Meditterranean Fever and Their Siblings
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2022 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sohag University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Familial Mediterranean Fever
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
CBC with differential ,ESR ,CRP, Amyloid level , FMF gene
Other Intervention Name(s)
liver and kidney function tests
Intervention Description
leucocytosis , high ESR and CRP ,amyloid level indicates inflammation positive FMF gene indicates having the disease .
Primary Outcome Measure Information:
Title
CBC
Description
leucocytosis
Time Frame
12 month
Title
amyloid level
Description
high in untreated patients
Time Frame
12 month
Title
FMF gene
Description
positive or negative
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Fever axillary temperature of >38ᵒC, 6-72 h of duration, ≥3 attacks
Abdominal pain 6-72 h of duration ≥3 attacks
Chest pain 6-72 h duration≥ 3 attacks
Arthritis 6-72 h duration ≥3 attacks, oligoarthritis
Family history of FMF*(11) B-sisters and brothers of a child with FMF with clinical or subclinical manifestation of FMF.
Exclusion Criteria:
Children with other auto inflammatory diseases, or with other diseases.
Persons above 18 years old.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
nahla a fawy, resident
Phone
01015681398
Email
nahlaabdelaziz@med.sohag.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
ashraf m redwan, assisstant professor
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osama R Elshrif, professor
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28624931
Citation
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.
Results Reference
background
PubMed Identifier
31524848
Citation
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.
Results Reference
background
PubMed Identifier
30686512
Citation
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.
Results Reference
background
PubMed Identifier
32676558
Citation
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.
Results Reference
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Clinical and Molecular Evaluation of Childern With Familial Meditterranean Fever and Their Siblings
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