Caspase-1 Activity, IL-1beta, and IL-18 in Patients With FMF (NCT06981520) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Caspase-1 Activity, IL-1beta, and IL-18 in Patients With FMF
Turkey (Türkiye)30 participantsStarted 2025-07-10
Plain-language summary
This study aims to investigate the intestinal mucosal expression of key inflammatory markers, namely Interleukin-1 (IL-1), Interleukin-18 (IL-18), and Caspase-1, in patients with Familial Mediterranean Fever (FMF). FMF is an autoinflammatory disorder characterized by recurrent episodes of fever and serosal inflammation. Recent studies suggest a possible role of intestinal immune activation in the disease pathogenesis, particularly through inflammasome-related cytokines. To better understand mucosal involvement in FMF, immunohistochemical staining for IL-1, IL-18, and Caspase-1 will be performed on intestinal biopsy samples obtained during routine endoscopic procedures. The staining intensity and distribution patterns will be evaluated and compared with age- and sex-matched healthy controls. The findings may help clarify mucosal inflammatory pathways involved in FMF and provide insight into novel therapeutic targets.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:Age 18 years or older
Confirmed diagnosis of Familial Mediterranean Fever (FMF) according to Tel-Hashomer clinical criteria and/or MEFV gene mutation analysis (for FMF group)
Undergoing routine endoscopy with mucosal biopsy sampling
Availability of sufficient formalin-fixed paraffin-embedded (FFPE) tissue for immunohistochemical analysis
For controls: absence of systemic inflammatory or autoimmune disease -
Exclusion Criteria:History of inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
Current use of immunosuppressive therapy (excluding colchicine)
Severe infection, active malignancy, or other systemic disease affecting intestinal mucosa
Inadequate biopsy specimen quality for histopathological evaluation
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Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Level of IL-1 in Mucosal Biopsies (Semi-Quantitative Score)
Timeframe: Single time point, Day 1 (during biopsy analysis)
2
Level of IL-18 in Mucosal Biopsies (Semi-Quantitative Score)
Timeframe: Single time point, Day 1 (during biopsy analysis)
3
Caspase-1 Expression in Mucosal Biopsies (Semi-Quantitative Score)
Timeframe: Single time point, Day 1 (during biopsy analysis)