Correlation Between Circulating Fibroblast Activation Protein (FAP) and Fibrosis in Two Diseases (Rheumatoid Arthritis and Systemic Sclerosis)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSohag University

About this trial

This study aims to measure a blood protein called fibroblast activation protein (FAP), which is linked to tissue scarring and inflammation. A small blood sample will be taken from participants (RA , SSc patients and healthy people ), and the FAP level will be measured and compared with routine clinical examinations, imaging studies, and lung function tests.

The purpose of this study is to improve understanding of disease activity and lung involvement in these conditions and to explore whether FAP could be useful as a blood marker for future patients. Participation in this study will not change the participant's usual medical care.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥18 years. Confirmed diagnosis of RA (ACR/EULAR) or SSc (ACR/EULAR).

Ability and willingness to provide informed consent. Cooperative patient able to answer questions.

Disqualifiers

Patients under 18 years' old

Active cancer or history of cancer within 5 years.

Other major fibrotic systemic disease that could confound circulating FAP levels.

Acute infection at time of sampling.

Trial population

The study population will include adult patients diagnosed with rheumatoid arthritis (RA) or systemic sclerosis (SSc). Participants will be recruited consecutively from the Rheumatology and Rehabilitation outpatient clinics and inpatient units of the study center. The sample will consist of three parallel groups: Patients with rheumatoid arthritis diagnosed according to the 2010 ACR/EULAR classification criteria. Patients with systemic sclerosis diagnosed according to the 2013 ACR/EULAR classification criteria. Healthy population who don't have any autoimmune disease.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

111 Participants
are grouped into 3 trial groups
Group A: Rheumatoid arthritis patients
Group B: systemic sclerosis patients
Group C: control healthy group

Trial outcomes

Primary outcomes

1

Serum fibroblast activation protein (FAP) concentration measured by ELISA in patients with rheumatoid arthritis and systemic sclerosis

Time frame
At baseline (Day 1)

Secondary outcomes

1

disease activity

Correlation between serum FAP concentration and disease activity score in rheumatoid arthritis and systemic sclerosis

Time frame
baseline
2

pulmonary involvement

Correlation between serum FAP concentration and pulmonary involvement in patients with rheumatoid arthritis and systemic sclerosis

Time frame
baseline

Other outcomes

Sponsors and contacts

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