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NCT02180126 Clinical Trial

Differing Levels of Positive Anti-Neutrophil Cytoplasm Antibody (ANCA) Test and Their Correlation With Vasculitis or Malignancy or Chronic Inflammation

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02180126
Other study ID # HYMC0041-14
Secondary ID
Status Not yet recruiting
Phase N/A
First received July 1, 2014
Last updated July 1, 2014
Start date August 2014
Est. completion date January 2015

Study information
Verified date July 2014
Source Hillel Yaffe Medical Center
Contact Tatiana Sivan, MD
Phone 972-4-630-4648
Email dk5@smile.net.il
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

A positive Anti-Neutrophil Cytoplasm Antibody (ANCA) test administered to patients with a high probability for vasculitis has high sensitivity and specificity for vasculitis. A positive ANCA test result in those patients who do not have a high probability for vasculitis requires extensive follow-up because those patients eventually present with malignancy or other inflammatory diseases. The investigators wish to investigate the correlation between the differing levels of positive ANCA tests and their relationship to vasculitis, malignancy and inflammatory diseases.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 160
Est. completion date January 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients with borderline positive ANCA test results

Exclusion Criteria:

- Pregnant

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

  • Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
  • Vasculitis

Intervention

Other:
• Follow-up
Follow-up of of patients with borderline positive ANCA test results

Locations
Country Name City State
Israel Hillel Yaffe Medical Center 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 Borderline Positive ANCA Borderline positive ANCA results of 12-19 U/ml is indication of possible malignancy or inflammatory diseases Two weeks No
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