ClinicalTrials.gg
Status unknownNCT05488561Updated Aug 4, 2022

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

An interventional study of CBC with differential ,ESR ,CRP, Amyloid level , FMF gene in Familial Mediterranean Fever, sponsored by Sohag University. Status unknown at 1 site in Egypt. Open to participants aged 1 Day to 18 Years. Per ClinicalTrials.gov, last updated 2022-08-04.

Sponsored by Sohag University · Not applicable, Interventional, and Screening

The sponsor has not verified this record recently (last verified Aug 2022), so the status shown — last known as Not yet recruiting — may be out of date.

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Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Randomized
Ages
1 Day to 18 Years
Sex
All
01

Study 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.

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Conditions studied

  • Familial Mediterranean Fever
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In context

Familial Mediterranean Fever

61 studies on the registry are indexed under Familial Mediterranean Fever; 27 are open to participants now.

This study's planned enrollment of 50 is above the median of 40 across 27 interventional studies indexed under Familial Mediterranean Fever.

Browse Familial Mediterranean Fever studies →

Lead sponsor

Sohag University is the lead sponsor of 1,232 studies on the registry; 638 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Day to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Interventions

  • Diagnostic testCBC with differential ,ESR ,CRP, Amyloid level , FMF gene

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

    Also known as: liver and kidney function tests

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What researchers measure

Primary outcomes

  1. CBC

    leucocytosis

    Time frame: 12 month

  2. amyloid level

    high in untreated patients

    Time frame: 12 month

  3. FMF gene

    positive or negative

    Time frame: 12 month

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Study locations

1 site
  • Sohag University Hospital
    Sohag, Egypt
    • Osama R Elshrif, professor · Contact
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References and documents

Publications

  • 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. PubMed 28624931 ↗
  • 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. PubMed 31524848 ↗
  • 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. PubMed 30686512 ↗
  • 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. PubMed 32676558 ↗

Individual participant data

Plan to share: Undecided

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Aug 2022; primary completion for Aug 2023, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 3, 2022
First posted
Aug 4, 2022
StartEst.
Aug 15, 2022
Primary completionEst.
Aug 2023
CompletionEst.
Aug 2023
Last update
Aug 4, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05488561
Lead sponsor
Sohag University
Responsible party
Nahla Abdelziz Fawy (resident doctor at pediatric department at faculty of medicine sohag university hospital, Sohag University) — Principal investigator
First posted
Aug 4, 2022
Start date
Aug 15, 2022 (estimated)
Primary completion
Aug 2023 (estimated)
Completion
Aug 2023 (estimated)
Last update
Aug 4, 2022

Study contacts

nahla a fawy, resident
Contact
nahlaabdelaziz@med.sohag.edu.eg
01015681398
ashraf m redwan, assisstant professor
Contact

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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