Assessing diagnostic accuracy in antiphospholipid syndrome
Official title: Negative Antiphospholipid Syndrome: a Multicentric Study
Run by Italian Society for Rheumatology · NCT06373003 · Data updated 2026-11-12
This study is trying to see if certain non-standard blood tests can help identify antiphospholipid syndrome in patients who have had blood clots or pregnancy issues, even if their regular tests come back negative.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 105 (estimated) |
| Sponsor | Italian Society for Rheumatology Academic / other |
| Locations | 1 site (Roma, Rome) |
| Status | Recruiting |
| Started | September 21, 2024 |
| Main results expected | September 2026 |
| Study ends | September 2026 |
| Registry record updated | May 14, 2025 |
| Trial ID | NCT06373003 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients under 65 years old with clinical criteria for APS but negative for conventional antiphospholipid antibodies.
✕Probably not a fit
Patients with known causes of thrombosis or obstetrical manifestations will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicentric, observational study aims to evaluate the diagnostic accuracy of non-criteria antiphospholipid antibodies in identifying antiphospholipid syndrome (APS) in patients experiencing thrombosis or recurrent adverse pregnancy outcomes. It focuses on seronegative antiphospholipid syndrome (SN-APS), where patients show clinical signs of APS but test negative for conventional antiphospholipid antibodies. By analyzing data from multiple Italian centers, the study seeks to clarify the relationship between non-criteria antibodies and clinical manifestations, potentially improving diagnostic strategies. The study is retrospective and cross-sectional in nature, promoting a better understanding of SN-APS and its implications.
Why it matters
Potential benefit: If successful, this study could enhance diagnostic accuracy for patients with antiphospholipid syndrome, leading to better management and treatment outcomes.
How similar studies have gone: While there is limited knowledge on seronegative antiphospholipid syndrome, recent studies suggest that exploring non-criteria antibodies may provide new insights, indicating a novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Umberto I Polyclinic, Rome- Department of Rheumatology
Roma, Rome, Italy Recruiting
Study contacts
- Study coordinator: Fabrizio Conti, MD
- Email: fabrizio.conti@uniroma1.it
- Phone: 06 49974631
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.