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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Hillel Yaffe Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT01238003
First received: November 9, 2010
Last updated: NA
Last verified: November 2010
History: No changes posted
  Purpose

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 Intervention
ANCA-related Vasculitis
 Other: Interpretation of blood test results

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective

Resource links provided by NLM:

MedlinePlus related topics: Vasculitis
U.S. FDA Resources

Further study details as provided by Hillel Yaffe Medical Center:

Primary Outcome Measures:
  • Mostly negative lab results [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 380
Study Start Date: December 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hospitalized patients Other: Interpretation of blood test results
Interpretation of blood test results

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients hospitalized in internal medicine ward

Criteria

Inclusion Criteria:

  • Blood samples sent for ANCA lab test

Exclusion Criteria:

  • Patients with ANCA vasculitis
  • Patients with known malignancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01238003

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

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

No publications provided

Responsible Party: Dr. Nina Avshovich, Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT01238003     History of Changes
Other Study ID Numbers: HYMC-10-0087
Study First Received: November 9, 2010
Last Updated: November 9, 2010
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Vasculitis
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013