Who may be eligible for the AGE and CALLY Index in Familial Mediterranean Fever trial?

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

ClinicalTrials.gov record NCT07439341

AGE and CALLY Index in Familial Mediterranean Fever

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Sep 17, 2026

Association Between Skin Autofluorescence-Measured Advanced Glycation End Products and the CALLY Index in Patients With Familial Mediterranean Fever: A Cross-Sectional Controlled Study

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusNot yet recruitingThe study has been registered but has not started enrolling. Sites and contacts may not be listed yet.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

Healthy volunteersAcceptedPeople who do not have the condition being studied who are allowed to take part. Some studies include both people with the condition and healthy volunteers; others may enrol only healthy volunteers.

Age18 years old to 65 years old

SexAll

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is an observational, cross-sectional case-control study of adults with Familial Mediterranean Fever (FMF) and age- and sex-matched healthy volunteers. Participants have a single, non-invasive skin autofluorescence measurement to assess advanced glycation end products (AGEs); routine lab results are used to calculate the CALLY index and other inflammatory and metabolic markers. No treatments or randomization are involved.

What it is studying. Whether tissue AGE levels measured non-invasively by skin autofluorescence are associated with the C-reactive protein–albumin–lymphocyte (CALLY) index in people with FMF. The study also compares AGE levels between FMF patients and matched healthy controls and explores relationships between AGE levels and inflammatory (CRP, ESR, SAA), metabolic (HbA1c, lipid profile), and renal markers.

What the researchers hope to learn. To evaluate whether skin-measured AGE burden relates to the CALLY index in FMF; to compare AGE levels in FMF versus matched healthy controls; and to examine associations between AGE levels and inflammatory, metabolic, and renal markers.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Device: Skin Autofluorescence Measurement

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Show the detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will have one non‑invasive, painless skin autofluorescence measurement applied to the inner (volar) forearm at baseline to measure advanced glycation end products (AGEs). The study will use routine laboratory results (CRP, albumin, lymphocyte count) from clinical care to calculate the CALLY index; no additional blood draw is required specifically for the skin measurement. Both FMF patients and healthy controls undergo the same one-time measurement. No treatments, interventions, or randomization are performed; procedures are described as minimal risk.

How the study is structured. Observational, cross-sectional case-control design. Each participant has one baseline visit with a painless skin autofluorescence (AGE) measurement; existing routine laboratory results will be used to calculate the CALLY index and assess inflammatory and metabolic markers. No treatment, device intervention beyond the measurement, or randomization is performed.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The registry says recruitment has not started. When is it expected to open, and can I register interest now?
No sites are listed on the registry yet. Where will the study take place?
Which of the eligibility criteria would need to be checked with tests before I could join?

More on familial Mediterranean fever

Clinical trials62 trials listed for familial Mediterranean feverEvery trial the registry lists for familial Mediterranean fever, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in familial Mediterranean fever researchLatest monthly update: September 2026. Includes: Colchicine form change. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Feb 1, 2026 (estimated)
Primary completion: Aug 1, 2026 (estimated)
Study completion: Nov 1, 2026 (estimated)
Target enrollment: 150 participants (estimated)
Last updated on registry: Feb 27, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Bursa City Hospital
Principal investigator: Altuğ Güner, Principal Investigator
Bursa City Hospital

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

altuğ güner 📞 02249750000 ✉ altugguner555@gmail.com

Participating sites

Study locations have not been posted on ClinicalTrials.gov yet. This study is not yet recruiting, so sites may be added when recruitment begins. The central study contact above may be able to tell you about planned sites.

Terms used on this page · explanations by MedicalUpdates.ai

randomization: Participants are assigned to the study groups by chance, like a coin toss, rather than chosen by the doctor or the participant. This is done so the groups are comparable.
follow-up: The period after treatment or enrolment during which participants are observed or contacted, for example to record side effects or outcomes.
written informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
baseline: Measurements taken at the start of the study, before any study treatment, so that later results can be compared with them.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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