An observational study in Familial Mediterranean Fever, sponsored by Bursa City Hospital. Not yet recruiting. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-27.
Sponsored by Bursa City Hospital · Observational
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.
Familial Mediterranean Fever (FMF) is a hereditary autoinflammatory disorder characterized by recurrent episodes of fever and serositis. Although clinical attacks are intermittent, persistent subclinical inflammation may continue between attacks and contribute to long-term complications such as amyloidosis and increased cardiovascular risk.
Advanced glycation end products (AGEs) are bioactive molecules formed through non-enzymatic glycation and oxidation of proteins and lipids. AGEs accumulate under chronic inflammatory and oxidative stress conditions and may perpetuate inflammation via activation of the AGE-RAGE signaling pathway. Increased AGE burden has been associated with chronic inflammatory and metabolic disorders.
Skin autofluorescence (SAF) is a validated, non-invasive method for assessing tissue AGE accumulation using the AGE Reader™ device (DiagnOptics Technologies B.V.). This method provides a rapid and painless measurement without requiring blood sampling.
The C-reactive protein-albumin-lymphocyte (CALLY) index is calculated using CRP, albumin, and lymphocyte count and reflects systemic inflammation and nutritional status. It has been investigated as a prognostic marker in several inflammatory conditions.
This single-center, observational, cross-sectional case-control study aims to:
Evaluate the association between SAF-measured AGE levels and the CALLY index in FMF patients.
Compare AGE levels between FMF patients and age- and sex-matched healthy controls.
Assess associations between AGE levels and inflammatory parameters (CRP, ESR, serum amyloid A).
Explore relationships between AGE levels and metabolic parameters (HbA1c, lipid profile) and renal involvement markers.
Eligible FMF patients aged 18-65 years who meet the Tel-Hashomer diagnostic criteria will be included. Healthy volunteers matched for age and sex will serve as controls. No treatment assignment, intervention, or randomization will be performed.
All laboratory parameters will be derived from routine clinical assessments. AGE measurements will be performed once at baseline using the skin autofluorescence method. The study poses minimal risk, as it is non-interventional and involves only non-invasive measurement procedures.
61 studies on the registry are indexed under Familial Mediterranean Fever; 27 are open to participants now.
This study's planned enrollment of 150 is above the median of 89 across 30 observational studies indexed under Familial Mediterranean Fever.
Browse Familial Mediterranean Fever studies →Bursa City Hospital is the lead sponsor of 71 studies on the registry; 31 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patients diagnosed with Familial Mediterranean Fever and age- and sex-matched healthy volunteers recruited from a single tertiary care center.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For FMF Patients:
For Healthy Controls:
Exclusion Criteria :
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients aged 18-65 years diagnosed with Familial Mediterranean Fever according to Tel-Hashomer criteria. Participants will undergo a single non-invasive skin autofluorescence measurement for assessment of advanced glycation end products (AGE). Routine laboratory parameters will be used to calculate the CALLY index. No intervention or treatment assignment will be performed.
Device: Skin Autofluorescence Measurement
Age- and sex-matched healthy volunteers without chronic inflammatory or metabolic disease. Participants will undergo a single non-invasive skin autofluorescence measurement for assessment of advanced glycation end products (AGE). No intervention or treatment assignment will be performed.
Device: Skin Autofluorescence Measurement
Non-invasive measurement of advanced glycation end products (AGE) using skin autofluorescence technology. The assessment is performed once at baseline using a validated optical device applied to the volar side of the forearm. The procedure is painless, requires no blood sampling, and does not involve any therapeutic intervention or treatment assignment.
Also known as: AGE Reader
Correlation Between Skin Autofluorescence-Measured AGE Levels and CALLY Index
Assessment of the association between advanced glycation end products (AGE) levels measured by skin autofluorescence and the C-reactive protein-albumin-lymphocyte (CALLY) index in patients with Familial Mediterranean Fever.
Time frame: Baseline
Comparison of AGE Levels Between FMF Patients and Healthy Controls
Comparison of skin autofluorescence-measured advanced glycation end product (AGE) levels between Familial Mediterranean Fever patients and age- and sex-matched healthy controls.
Time frame: Baseline
Association Between AGE Levels and Inflammatory Parameters
Evaluation of the relationship between AGE levels and inflammatory markers including C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), and serum amyloid A (SAA).
Time frame: Baseline
Association Between AGE Levels and Metabolic Parameters
Assessment of the association between AGE levels and metabolic markers including HbA1c and lipid profile (total cholesterol, HDL, LDL).
Time frame: Baseline
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Familial Mediterranean Fever →
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