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

NCT07393217 | Not Yet Recruiting

• 1 other identifier: Soh-Med--25-12-9MD
• Study Type: observational
• Target: 111
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis (RA); Systemic Sclerosis (SSc)

Keywords

Fibroblast Activation protein; Rheumatoid Arthritis; systemic sclerosis; lung fibrosis; skin fibrosis

Outcome Measures

Primary Outcomes (1)

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

  At baseline (Day 1)

Secondary Outcomes (2)

• disease activity

  baseline

• pulmonary involvement

  baseline

Study Arms (3)

Rheumatoid arthritis patients

systemic sclerosis patients

control healthy group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pregnancy or breastfeeding.
• Other autoimmune diseases

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Arthritis, Rheumatoid; Scleroderma, Systemic; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin Diseases; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer at Rheumatology department, Sohag University Hospital

Study Record Dates

• First Submitted: January 18, 2026
• First Posted: February 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 6, 2026

Record last verified: 2026-01

Locations

EG (1)