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

January 31, 2026 updated by: Toqa Mahfouz Mohamed Ahmed, Sohag University

Circulating Fibroblast Activation Protein (FAP) As A Marker for Fibroblast-Driven Pathology in Rheumatoid Arthritis and Systemic Sclerosis : Implication for Joint, Skin and Lung Fibrosis

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Sohag, Egypt
        • Sohag University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Rheumatoid arthritis patients
systemic sclerosis patients
control healthy group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum fibroblast activation protein (FAP) concentration measured by ELISA in patients with rheumatoid arthritis and systemic sclerosis
Time Frame: At baseline (Day 1)
At baseline (Day 1)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease activity
Time Frame: baseline
Correlation between serum FAP concentration and disease activity score in rheumatoid arthritis and systemic sclerosis
baseline
pulmonary involvement
Time Frame: baseline
Correlation between serum FAP concentration and pulmonary involvement in patients with rheumatoid arthritis and systemic sclerosis
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sohag University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

January 18, 2026

First Submitted That Met QC Criteria

January 31, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

January 31, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Soh-Med--25-12-9MD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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