Assessing diagnostic accuracy in antiphospholipid syndrome
Negative Antiphospholipid Syndrome: a Multicentric Study
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 |
|---|---|
| Enrollment | 105 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Italian Society for Rheumatology Academic / other |
| Locations | 1 site (Roma, Rome) |
| Trial ID | NCT06373003 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include patients under 65 years old with clinical criteria for APS but negative for conventional antiphospholipid antibodies.
Not a fit: Patients with known causes of thrombosis or obstetrical manifestations will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Roma, Rome
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.