Clincosm LogoSign in Get a demo

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

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05488561
Collaborator
(none)
50
Enrollment
1
Location
11.5
Anticipated Duration (Months)
4.3
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: CBC with differential ,ESR ,CRP, Amyloid level , FMF gene
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Clinical and Molecular Evaluation of Childern With Familial Meditterranean Fever and Their Siblings
Anticipated Study Start Date :
Aug 15, 2022
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Aug 1, 2023

Outcome Measures

Primary Outcome Measures

  1. CBC [12 month]

    leucocytosis

  2. amyloid level [12 month]

    high in untreated patients

  3. FMF gene [12 month]

    positive or negative

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sohag University Hospital Sohag Egypt

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Nahla Abdelziz Fawy, resident doctor at pediatric department at faculty of medicine sohag university hospital, Sohag University
ClinicalTrials.gov Identifier:
NCT05488561
Other Study ID Numbers:
  • Soh_Med_22_07_20
First Posted:
Aug 4, 2022
Last Update Posted:
Aug 4, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Brucellosis
Familial Mediterranean Fever
Hereditary Autoinflammatory Diseases
Fever

Study Results

No Results Posted as of Aug 4, 2022