AGE and CALLY Index in Familial Mediterranean Fever (NCT07439341) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
AGE and CALLY Index in Familial Mediterranean Fever
150 participantsStarted 2026-02-01
Plain-language summary
Familial Mediterranean Fever (FMF) is an autoinflammatory disease characterized by recurrent inflammatory attacks and persistent low-grade inflammation. Even during attack-free periods, subclinical inflammation may continue and contribute to long-term complications.
Advanced glycation end products (AGEs) are molecules that accumulate under chronic inflammatory and oxidative stress conditions. AGEs can be measured non-invasively using skin autofluorescence (SAF). The C-reactive protein-albumin-lymphocyte (CALLY) index is a composite marker derived from routine laboratory parameters and reflects systemic inflammation and nutritional status.
This observational cross-sectional study aims to evaluate the association between skin autofluorescence-measured AGE levels and the CALLY index in patients with FMF. The study will also compare AGE levels between FMF patients and age- and sex-matched healthy controls.
The study does not involve any intervention, treatment assignment, or randomization. All laboratory parameters will be obtained from routine clinical evaluations, and AGE measurement will be performed using a non-invasive device.
Who can participate
Age range
18 Years – 65 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:
For FMF Patients:
* Age between 18 and 65 years
* Diagnosis of Familial Mediterranean Fever according to Tel-Hashomer criteria
* At least 6 months of clinical follow-up
* Available routine laboratory data (CRP, albumin, lymphocyte count)
* Not in an acute FMF attack at the time of assessment
* Ability to provide written informed consent
For Healthy Controls:
* Age between 18 and 65 years
* No history of chronic inflammatory, autoimmune, metabolic, or renal disease
* Ability to provide written informed consent
Exclusion Criteria :
* Diagnosis of diabetes mellitus
* Chronic kidney disease stage 3 or higher
* Active infection
* Malignancy within the past 5 years
* Dermatologic condition affecting the forearm measurement site
* Use of high-dose antioxidant or vitamin supplementation within the past 3 months
* Any condition that, in the opinion of the investigators, may interfere with study participation
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
Correlation Between Skin Autofluorescence-Measured AGE Levels and CALLY Index