Negative Antiphospholipid Syndrome: a Multicentric Study

NCT06373003 | Recruiting

• 1 other identifier: SNAPSITA
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Antiphospholipid Syndrome; Seronegative Antiphospholipid Syndrome

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of non-criteria aPL

  Evaluation of the sensitivity and specificity of non-criteria aPL (anti-vimentin/cardiolipin and anti-phosphatidylserine/prothrombin) in identifying APS in patients with thrombosis/recurrent adverse pregnancy outcomes

  0 months

Secondary Outcomes (2)

• Frequency of clinical characteristics in the aPL groups

  0 months

• Incidence of recurrent thrombosis and pregnancy complications

  0 months

Other Outcomes (1)

• Prevalence of APS- and SN-APS-related antibodies in study groups

  0 months

Study Arms (3)

Group 1 [APS]

Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SN-APS)

Other: Diagnostic accuracy

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)

Other: Diagnostic accuracy

Group 3 [Control Group]

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)

Interventions

Diagnostic accuracy OTHER

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

Group 1 [APS]; Group 2 [SN-APS]

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Investigators plan to include a minimum sample size of 35 patients for each group; all patients will have the following features: * patients affected by Antiphospholipid syndrome (APS) or Seronegative antiphospholipid syndrome (SN-APS) or patients with clinical criteria (thrombotic or obstetric) for APS, negative for aPL, but without clinical features highly suggestive of APS * Age \<65 years (at the event time) * Less than 5 years from the first event to the beginning of the study

You may qualify if:

• Group 1 \[APS\]: Patients fulfilling the classification criteria for antiphospholipid syndrome (seropositive APS, SP-APS)
• 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)
• 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).
• Age \< 65 years (at event time)
• Less than 5 years from the first even

You may not qualify if:

• Group 2 and 3: patients with a known cause of thrombosis or obstetrical manifestations
• Deceased patients
• Less than 5 years from the first event

Sponsors & Collaborators

• Italian Society for Rheumatology: lead

Study Sites (1)

Umberto I Polyclinic, Rome- Department of Rheumatology

Roma, Rome, 00185, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples will be collected on two occasions at least 12 weeks apart for each patient; the aPL criteria will be tested in each recruitment centre, as a routine practice, whilst the non-criterion aPL will be tested in the centralized laboratory at the Department of "Experimental Medicine', Umberto I Polyclinic in Rome

MeSH Terms

Conditions

Antiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Fabrizio Conti, MD

CONTACT

06 49974631; fabrizio.conti@uniroma1.it

Simona Truglia, MD

CONTACT

06 49974631; simona.truglia@uniroma1.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2024
• First Posted: April 18, 2024
• Study Start: September 21, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)