Familial Mediterranean FeverNCT05488561
Clinical and Molecular Evaluation of Childern With Familial Meditterranean Fever and Their Siblings
A study testing CBC with differential ,ESR ,CRP, Amyloid level , FMF gene in people with Familial Mediterranean Fever, run by Sohag University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 18 years
- Conditions the study is for
- Familial Mediterranean Fever
- What is being tested?
- CBC with differential ,ESR ,CRP, Amyloid level , FMF gene
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Aug 2022to Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Children with other auto inflammatory diseases, or with other diseases.
- Persons above 18 years old.
Trial locations and contacts
1 site in 1 country.
ashraf m redwan, assisstant professor contact
About this study
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.
- Conditions
- Familial Mediterranean Fever
- Being tested
- CBC with differential ,ESR ,CRP, Amyloid level , FMF gene
- Medical subject headings
- Familial Mediterranean Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBC with differential ,ESR ,CRP, Amyloid level , FMF geneDiagnostic test
Also called liver and kidney function tests
leucocytosis , high ESR and CRP ,amyloid level indicates inflammation positive FMF gene indicates having the disease .
What is being measured
The primary outcome is the main question the study is designed to answer.
CBC
leucocytosis
Measured: 12 month
amyloid level
high in untreated patients
Measured: 12 month
FMF gene
positive or negative
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2022
- Study start15 Aug 2022 (estimated)
- Primary completionAug 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Familial Mediterranean FeverStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nahla Abdelziz Fawy, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05488561
- Sponsor's protocol ID
- Soh_Med_22_07_20
- Status last verified
- Aug 2022
- First submitted
- 3 Aug 2022
- Last updated
- 4 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 28624931Cakan 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 31524848Ozdogan 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 30686512Talaat 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
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Molecular Evaluation of Childern With Familial Meditterranean Fever and Their Siblings
- ClinicalTrials.gov ID
- NCT05488561
- Acronym / sponsor ID
- Soh_Med_22_07_20
- Conditions
- Familial Mediterranean Fever
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Aug 2022 (estimated)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 4 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 1 day to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- Children with other auto inflammatory diseases, or with other diseases.
- Persons above 18 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBC with differential ,ESR ,CRP, Amyloid level , FMF geneAlso: liver and kidney function testsleucocytosis , high ESR and CRP ,amyloid level indicates inflammation positive FMF gene indicates having the disease . | Diagnostic test | – |
Primary outcome
CBC
Time frame: 12 month
leucocytosis
amyloid level
Time frame: 12 month
high in untreated patients
FMF gene
Time frame: 12 month
positive or negative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2022.
- Background: PubMed 28624931Alghamdi 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.
- Background: PubMed 31524848Cakan 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.
- Background: PubMed 30686512Ozdogan 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.
- Background: PubMed 32676558Talaat 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ashraf m redwan, assisstant professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBC with differential ,ESR ,CRP, Amyloid level , FMF gene in people with Familial Mediterranean Fever, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact nahla a fawy, resident (01015681398, nahlaabdelaziz@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CBC (time frame: 12 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05488561, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2022.