Ailesel Akdeniz AteşiNCT06451471
"Galectin-3 as a Marker of Subclinical Inflammation in FMF"
An observational study of Ailesel Akdeniz Ateşi, run by Turkish League Against Rheumatism at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about the relationship between serum Galectin-3 levels and subclinical inflammation in patients with Familial Mediterranean Fever (FMF). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ailesel Akdeniz Ateşi
- How many people
- 154 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2021to 1 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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: 1. Aged between 18 and 65 years, 2. Able to provide written informed consent for the study, 3. Literate, 4. Diagnosed with Familial Mediterranean Fever (FMF) according to the Tel Hashomer criteria and not currently experiencing an attack (with at least 15 days since the last attack).
Who may be able to join
- for the Patient Group:
- Aged between 18 and 65 years,
- Able to provide written informed consent for the study,
- Literate,
- Diagnosed with Familial Mediterranean Fever (FMF) according to the Tel Hashomer criteria and not currently experiencing an attack (with at least 15 days since the last attack).
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- Aged between 18 and 65 years,
- Able to provide written informed consent for the study,
- Literate.
Who cannot join
- Presence of known inflammatory diseases other than FMF,
- Presence of known systemic, chronic, severe medical conditions,
- Presence of active infection,
- Conditions affecting cognitive functions such as mental retardation, delirium, dementia, epilepsy, and alcohol or substance use disorders,
- Being pregnant or in the lactation period.
- Presence of known systemic, chronic, severe medical conditions,
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- Presence of inflammatory diseases,
- Presence of active infection,
- Conditions affecting cognitive functions such as mental retardation, delirium, dementia, epilepsy, and alcohol or substance use disorders,
- Being pregnant or in the lactation period. -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Faculty of Medicine
Erzurum, 25240
About this study
Official title: Assessment of Serum Galectin-3 Level as an Indicator of Subclinical Inflammation in Patients With Familial Mediterranean Fever
The goal of this observational study is to learn about the relationship between serum Galectin-3 levels and subclinical inflammation in patients with Familial Mediterranean Fever (FMF). The main questions it aims to answer are:
- Are serum Galectin-3 levels higher in FMF patients compared to healthy controls?
- Is there a positive correlation between serum Galectin-3 levels and Serum Amyloid A (SAA) protein levels in FMF patients?
Read more
Participants will:
- Provide blood samples to measure serum Galectin-3 and SAA levels.
- Complete a sociodemographic and clinical data form.
- Fill out the FMF Quality of Life (QoL) scale.
Researchers will compare FMF patients and healthy controls to see if there are significant differences in serum Galectin-3 levels and to determine the correlation between Galectin-3 and SAA protein levels in FMF patients.
- Conditions
- Ailesel Akdeniz Ateşi
- Keywords
- GALEKTİN-3, Subclinical Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator: Group 1 | PATIENT GROUP DIAGNOSED WITH FMF | |
| Active Comparator: Group 2 | HEALTHY CONTROL GROUP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Galectin-3 Levels
Comparison of serum Galectin-3 levels between FMF patients and healthy controls to determine if there is a significant difference.
Measured: 2022
Secondary outcomes (3)
Serum Amyloid A (SAA) Levels
Measurement of SAA levels in both FMF patients and healthy controls.
Measured: 2022
Correlation Analysis
Determination of the correlation between serum Galectin-3 levels and SAA levels in FMF patients.
Measured: 2022
Clinical Variables
Analysis of the relationship between Galectin-3/SAA levels and clinical variables such as age, BMI, disease duration, and frequency of FMF attacks.
Measured: 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 May 2021
- Primary completion1 Nov 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ailesel Akdeniz AteşiStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turkish League Against Rheumatism
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oguzhan Lacin, Turkish League Against Rheumatism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451471
- Sponsor's protocol ID
- TRASD-OL-TEZ
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Serum Galectin-3 Level as an Indicator of Subclinical Inflammation in Patients With Familial Mediterranean Fever
- ClinicalTrials.gov ID
- NCT06451471
- Acronym / sponsor ID
- TRASD-OL-TEZ
- Conditions
- Ailesel Akdeniz Ateşi
- Keywords
- GALEKTİN-3, Subclinical Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Turkish League Against RheumatismUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 1 Nov 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 11 Jun 2024 (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.
The goal of this observational study is to learn about the relationship between serum Galectin-3 levels and subclinical inflammation in patients with Familial Mediterranean Fever (FMF). The main questions it aims to answer are:
- Are serum Galectin-3 levels higher in FMF patients compared to healthy controls?
- Is there a positive correlation between serum Galectin-3 levels and Serum Amyloid A (SAA) protein levels in FMF patients?
Participants will:
- Provide blood samples to measure serum Galectin-3 and SAA levels.
- Complete a sociodemographic and clinical data form.
- Fill out the FMF Quality of Life (QoL) scale.
Researchers will compare FMF patients and healthy controls to see if there are significant differences in serum Galectin-3 levels and to determine the correlation between Galectin-3 and SAA protein levels in FMF patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator: Group 1 | – | –PATIENT GROUP DIAGNOSED WITH FMF |
| Active Comparator: Group 2 | – | –HEALTHY CONTROL GROUP |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Aged between 18 and 65 years, 2. Able to provide written informed consent for the study, 3. Literate, 4. Diagnosed with Familial Mediterranean Fever (FMF) according to the Tel Hashomer criteria and not currently experiencing an attack (with at least 15 days since the last attack).
Key inclusion criteria (9 listed)
- for the Patient Group:
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Key exclusion criteria (10 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum Galectin-3 Levels
Time frame: 2022
Comparison of serum Galectin-3 levels between FMF patients and healthy controls to determine if there is a significant difference.
3 secondary outcomes
Serum Amyloid A (SAA) Levels
Time frame: 2022
Correlation Analysis
Time frame: 2022
Clinical Variables
Time frame: 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ailesel Akdeniz Ateşi, run by Turkish League Against Rheumatism at 1 site in Turkey (Türkiye).
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 9 inclusion and 10 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: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Galectin-3 Levels (time frame: 2022). 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 11 Jun 2024.