Study type

Study topic

Other

Study topic, other

Diagnostic procedure- Antinuclear antibodies (ANA) screening to measure serum levels of soluble intercellular adhesion molecule-1 (sICAM-1), endothelial-leukocyte adhesion molecule-1 (sELAM-1), and vascular cell adhesion molecule-1 (sVCAM-1)

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)

Data collection methods

Primary data collection
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Case-series
Population studied

Short description of the study population

Antinuclear antibodies (ANA)-positive patients defined as a titer of at least 1:160.

Age groups

  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
  • Adults (75 to < 85 years)
  • Adults (85 years and over)

Special population of interest

Immunocompromised

Estimated number of subjects

100
Study design details

Main study objective

Antinuclear antibodies (ANA) serve as screening tests for connective tissue diseases but have low specificity. In this pilot study we aimed to identify patients with first-time positive ANA and musculoskeletal complaints, and correlate serum soluble vascular adhesion molecules as biomarkers.

Outcomes

This study suggests that sVCAM-1 is a disease marker independent from standard serum parameters in several rheumatic diseases.

Data analysis plan

Prospective, observational study with 100 ANA-positive patients, comparing them to age- and gender-matched healthy controls (HC, n=75). Serum levels of soluble intercellular adhesion molecule-1 (sICAM-1), endothelial-leukocyte adhesion molecule-1 (sELAM-1), and vascular cell adhesion molecule-1 (sVCAM-1) were measured. A subgroup of patients with systemic sclerosis (SSc) treated with immunosuppressants was followed over 10 months.