"Galectin-3 as a Marker of Subclinical Inflammation in FMF"

NCT ID: NCT06451471

Last Updated: 2024-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

154 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-11-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ailesel Akdeniz Ateşi

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Active Comparator: Group 1

PATIENT GROUP DIAGNOSED WITH FMF

No interventions assigned to this group

Active Comparator: Group 2

HEALTHY CONTROL GROUP

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* for the Patient Group:

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).


<!-- -->

1. Aged between 18 and 65 years,
2. Able to provide written informed consent for the study,
3. Literate.

Exclusion Criteria

1. Presence of known inflammatory diseases other than FMF,
2. Presence of known systemic, chronic, severe medical conditions,
3. Presence of active infection,
4. Conditions affecting cognitive functions such as mental retardation, delirium, dementia, epilepsy, and alcohol or substance use disorders,
5. Being pregnant or in the lactation period.

1. Presence of known systemic, chronic, severe medical conditions,
2. Presence of inflammatory diseases,
3. Presence of active infection,
4. Conditions affecting cognitive functions such as mental retardation, delirium, dementia, epilepsy, and alcohol or substance use disorders,
5. Being pregnant or in the lactation period. -
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Turkish League Against Rheumatism

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Oguzhan Lacin

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ataturk University Faculty of Medicine

Erzurum, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TRASD-OL-TEZ

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.