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Clinical Trials in Italy / NCT06373003
Recruiting Observational

Negative Antiphospholipid Syndrome: a Multicentric Study

NCT06373003 · tracked via the Priya Life Science Italy tracker
Sponsor
Italian Society for Rheumatology
Phase
Observational
Started
2024-09-21
Last updated
2025-05-14

Condition(s) studied

Antiphospholipid SyndromeSeronegative Antiphospholipid Syndrome

Investigational drug(s) / intervention(s)

Diagnostic accuracy

Diagnostic accuracy: To assess the diagnostic accuracy of non-criteria aPL (anti-vimentin/cardiolipin and anti-phosphatidylserine/prothrombin) in identifying APS in patients with thrombosis/ recurrent adverse pregnancy outcomes

Study summary

Multicentre no-profit, national, (cross-sectional diagnostic) retrospective study, promoted by the Italian Society for Rheumatology.

The main objective of the study is to assess the diagnostic accuracy of non-criteria aPL (anti-vimentin/cardiolipin and anti-phosphatidylserine/prothrombin) in identifying APS in patients with thrombosis/recurrent adverse pregnancy outcomes.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
INCLUSION CRITERIA: 1. Group 1 \[APS\]: Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SP-APS) 2. Group 2 \[SN-APS\]: patients with seronegative APS (SN-APS): with clinical criteria (thrombotic or obstetric) for APS, persistently negative for aPL, and with clinical features highly suggestive of APS (recurrent events, thrombotic + obstetrical events, extra-criteria manifestations, other autoimmune diseases) 3. Group 3: patients with clinical criteria (thrombotic or obstetric) for APS, negative for aPL, but without clinical features highly suggestive of APS (recurrent events, thrombotic + obstetrical events, extra-criteria manifestations, other autoimmune diseases). 4. Age \< 65 years (at event time) 5. Less than 5 years from the first even EXCLUSION CRITERIA 1. Group 2 and 3: patients with a known cause of thrombosis or obstetrical manifestations 2. Deceased patients 3. Less than 5 years from the first event

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Umberto I Polyclinic, Rome- Department of Rheumatology Roma Rome Recruiting

More Italian Society for Rheumatology trials in Italy

Ultrasound to Guide Treatment Decisions in Patients With Rheumatoid Arthritis According to a T2T Approach Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06373003 on ClinicalTrials.gov ↗ ← All trials in Italy