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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
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:


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

Ages Eligible for Study:   Child, Adult, Senior
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01238003

Locations
Israel
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 
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 December 08, 2016