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Negative Antiphospholipid Syndrome: a Multicentric Study

Recruitingn/aAges 18 Years - 65 YearsAllItalian Society for Rheumatology
NCT06373003 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Diagnostic accuracy
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Where

1 site
Umberto I Polyclinic, Rome- Department of Rheumatology
Roma, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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