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

July 1, 2014 updated by: Hillel Yaffe Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center
        • Principal Investigator:
          • Tatiana Sivan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with borderline positive ANCA test results who had been hospitalized at the Hillel Yaffe Medical Center.

Description

Inclusion Criteria:

  • Patients with borderline positive ANCA test results

Exclusion Criteria:

  • Pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Positive ANCA
Patients with borderline positive ANCA results.
Other: Follow-up
Follow-up of of patients with borderline positive ANCA test results

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Borderline Positive ANCA
Time Frame: Two weeks
Borderline positive ANCA results of 12-19 U/ml is indication of possible malignancy or inflammatory diseases
Two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Study Director: Nina Avshovich, MD, Hillel Yaffe Medical Center
  • Principal Investigator: Tatiana Sivan, MD, Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Anticipated)

January 1, 2015

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

July 1, 2014

First Submitted That Met QC Criteria

July 1, 2014

First Posted (Estimate)

July 2, 2014

Study Record Updates

Last Update Posted (Estimate)

July 2, 2014

Last Update Submitted That Met QC Criteria

July 1, 2014

Last Verified

July 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC0041-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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