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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01238003
Other study ID # HYMC-10-0087
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 9, 2010
Last updated November 9, 2010
Start date December 2010
Est. completion date December 2011

Study information

Verified date November 2010
Source Hillel Yaffe Medical Center
Contact Nina Avshovich, MD
Phone 972-52-5566049
Email ninaa@hy.health.gov.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 380
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Blood samples sent for ANCA lab test

Exclusion Criteria:

- Patients with ANCA vasculitis

- Patients with known malignancy

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Other:
Interpretation of blood test results
Interpretation of blood test results

Locations

Country Name City State
Israel Hillel Yaffe MC, Hadera

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Mostly negative lab results One year No