Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-25 @ 4:08 AM
NCT ID:
NCT06981520
Eligibility Criteria:
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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Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06981520
Study Brief:
Protocol Section:
NCT06981520