Hematological Indices in Pediatric Diagnosed with Familial Mediterranean Fever

NCT06583304 | Not Yet Recruiting

• 1 other identifier: familial Mediterranean fever
• Study Type: observational
• Target: 93
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate the relationship between the hematological indices and subclinical inflammation in FMF patients during their attack-free period, additionally this study aims to assess the potential of these indices as predictive markers for ongoing inflammation in these patients population at Assuit university hospital of pediatrics.

Conditions

Familial Mediterranean Fever (FMF )

Outcome Measures

Primary Outcomes (1)

• investigate the association of haematological indices with subclinical inflammation

  investigate the association of hematological indices with subclinical inflammation and to evaluate their usability as predictors of ongoing inflammation in FMF patients during their attack-free period in Assiut university hospital and to describe the clinical characteristics of patients diagnosed as FMF in Upper Egypt, and to find the most common presenting symptoms.

  Baseline

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Their clinical presentation and laboratory finding should fulfill the diagnostic criteria as mentioned by Tel Hashomer criteria in pediatrics (≥2 criteria) and Eurofever /PRINTO criteria (≥6 criteria) and confirmed by genetic testing of the most common 12 genetic variants in MEFV gene

You may qualify if:

• Age at enrollment less than18 years.
• Both sexes.
• Diagnosed as familial Mediterranean fever according to Tel-Hashomer criteria in pediatrics and Eurofever /PRINTO criteria

You may not qualify if:

• Patients with acute or chronic active infections. 2- Patients with pre-existing illness as chronic lung, liver or renal diseases. 3- Patients with diabetes mellitus, atherosclerotic vascular disease. 4- Patients with malignancy

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Lancieri M, Bustaffa M, Palmeri S, Prigione I, Penco F, Papa R, Volpi S, Caorsi R, Gattorno M. An Update on Familial Mediterranean Fever. Int J Mol Sci. 2023 May 31;24(11):9584. doi: 10.3390/ijms24119584.

  PMID: 37298536 BACKGROUND

• Assouad E, El Hage S, Safi S, El Kareh A, Mokled E, Salameh P. Familial Mediterranean fever research activity in the Arab world: the need for regional and international collaborations. East Mediterr Health J. 2021 Oct 27;27(10):984-992. doi: 10.26719/emhj.21.036.

  PMID: 34766324 BACKGROUND

• Tufan A, Lachmann HJ. Familial Mediterranean fever, from pathogenesis to treatment: a contemporary review. Turk J Med Sci. 2020 Nov 3;50(SI-2):1591-1610. doi: 10.3906/sag-2008-11.

  PMID: 32806879 BACKGROUND

MeSH Terms

Conditions

Familial Mediterranean Fever

Condition Hierarchy (Ancestors)

Hereditary Autoinflammatory Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

khaled mohamed Ahmed Aboelsaud, Bachelor of Medicine

CONTACT

01111520361; Km5651466@gmail.com

Naglaa Samy Mohamed Osman, Lecturer of Pediatrics

CONTACT

01002673103; Naglaaosman84@edu.eg

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 71515,Assiut

Study Record Dates

• First Submitted: September 1, 2024
• First Posted: September 4, 2024
• Study Start: October 13, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: September 4, 2024

Record last verified: 2024-09