Familial Mediterranean FeverNCT07439341
AGE and CALLY Index in Familial Mediterranean Fever
An observational study of Familial Mediterranean Fever, run by Bursa City Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Familial Mediterranean Fever
- What is being tested?
- Skin Autofluorescence Measurement
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients diagnosed with Familial Mediterranean Fever and age- and sex-matched healthy volunteers recruited from a single tertiary care center.
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Association Between Skin Autofluorescence-Measured Advanced Glycation End Products and the CALLY Index in Patients With Familial Mediterranean Fever: A Cross-Sectional Controlled Study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Familial Mediterranean Fever
- Being tested
- Skin Autofluorescence Measurement
- Keywords
- Advanced Glycation End Products, Skin Autofluorescence, CALLY Index, Amyloidosis, Inflammatory Biomarkers
- Medical subject headings
- Familial Mediterranean Fever, Amyloidosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin Autofluorescence MeasurementDevice
Also called AGE Reader
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.
| Study group | Role | What they receive |
|---|---|---|
| Familial Mediterranean Fever Patients | 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. Receives: Device: Skin Autofluorescence Measurement | |
| Healthy Controls | 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. Receives: Device: Skin Autofluorescence Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (3)
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.
Measured: 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).
Measured: 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).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Familial Mediterranean FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Altuğ Güner, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439341
- Sponsor's protocol ID
- 2026rheumotology-3
- Status last verified
- Feb 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Skin Autofluorescence-Measured Advanced Glycation End Products and the CALLY Index in Patients With Familial Mediterranean Fever: A Cross-Sectional Controlled Study
- ClinicalTrials.gov ID
- NCT07439341
- Acronym / sponsor ID
- 2026rheumotology-3
- Conditions
- Familial Mediterranean Fever
- Keywords
- Advanced Glycation End Products, Skin Autofluorescence, CALLY Index, Amyloidosis, Inflammatory Biomarkers
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Bursa City HospitalOther government
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Familial Mediterranean Fever Patients | – | Device: Skin Autofluorescence MeasurementPatients 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. |
| Healthy Controls | – | Device: Skin Autofluorescence MeasurementAge- 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients diagnosed with Familial Mediterranean Fever and age- and sex-matched healthy volunteers recruited from a single tertiary care center.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Skin Autofluorescence MeasurementAlso: AGE ReaderNon-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. | Device | Familial Mediterranean Fever Patients, Healthy Controls |
Primary outcome
Correlation Between Skin Autofluorescence-Measured AGE Levels and CALLY Index
Time frame: Baseline
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.
3 secondary outcomes
Comparison of AGE Levels Between FMF Patients and Healthy Controls
Time frame: Baseline
Association Between AGE Levels and Inflammatory Parameters
Time frame: Baseline
Association Between AGE Levels and Metabolic Parameters
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Familial Mediterranean Fever
RecruitingObservational study
Familial Mediterranean Fever and Related Disorders: Genetics and Disease Characteristics
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Not yet recruitingPhase 3
Goflikicept for Resolution and Prevention of Attacks in Pediatric and Adolescent Patients With Colchicine-Resistant or Colchicine-Intolerant Familial Mediterranean Fever
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Genotype and Phenotype in Pediatric Familial Mediterranean Fever
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Familial Mediterranean Fever, run by Bursa City Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact altuğ güner (02249750000, altugguner555@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Skin Autofluorescence-Measured AGE Levels and CALLY Index (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.