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

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ClinicalTrials.gov Identifier: NCT01238003
Recruitment Status : Unknown
Verified November 2010 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 10, 2010
Last Update Posted : November 10, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
ANCA-related Vasculitis Other: Interpretation of blood test results

Study Design

Study Type : Observational
Estimated Enrollment : 380 participants
Observational Model: Cohort
Time Perspective: Retrospective
Study Start Date : December 2010
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vasculitis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Hospitalized patients Other: Interpretation of blood test results
Interpretation of blood test results

Outcome Measures

Primary Outcome Measures :
  1. Mostly negative lab results [ Time Frame: One year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients hospitalized in internal medicine ward

Inclusion Criteria:

  • Blood samples sent for ANCA lab test

Exclusion Criteria:

  • Patients with ANCA vasculitis
  • Patients with known malignancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01238003

Contact: Nina Avshovich, MD 972-52-5566049 ninaa@hy.health.gov.il

Hillel Yaffe MC,
Hadera, Israel
Sponsors and Collaborators
Hillel Yaffe Medical Center
More Information

Responsible Party: Dr. Nina Avshovich, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01238003     History of Changes
Other Study ID Numbers: HYMC-10-0087
First Posted: November 10, 2010    Key Record Dates
Last Update Posted: November 10, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases