Clinical Relevance of Anti-Neutrophil Cytoplasm Antibody (ANCA)in Hospitalized Patients

• Conditions: ANCA-related Vasculitis
• Interventions: Other: Interpretation of blood test results

• Registration Number: NCT01238003
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

Laboratory testing of Anti-Neutrophil Cytoplasm Antibody (ANCA) is used to confirm diagnosis of patients who have a high level of suspicion for ANCA-related vasculitis. In these patients the specificity and sensitivity to the ANCA test is very high. This study hopes to prove that when this lab test is performed on blood of patients who do not have a high level of suspicion for ANCA-related vasculitis, the sensitivity and specificity is reduced and there are many false positive results. Because of this, it should not be used as a screening test for a more general patient population.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-11
• Study First Submitted: 2010-11-09
• Study First Submitted QC: 2010-11-09
• Last Update Submitted: 2010-11-09
• Study First Posted: 2010-11-10
• Last Update Posted: 2010-11-10
• Study Start: 2010-12
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 380

Inclusion Criteria

• Blood samples sent for ANCA lab test

Exclusion Criteria

• Patients with ANCA vasculitis
• Patients with known malignancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hospitalized patients	Interpretation of blood test results	-

Primary Outcome Measures

Name	Time	Method
Mostly negative lab results	One year

Trial Locations

Locations (1)

Hillel Yaffe MC,; 🇮🇱 Hadera, Israel