NCT02180126

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 2, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2014

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

July 2, 2014

Status Verified

July 1, 2014

Enrollment Period

5 months

First QC Date

July 1, 2014

Last Update Submit

July 1, 2014

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Outcome Measures

Primary Outcomes (1)

  • Borderline Positive ANCA

    Borderline positive ANCA results of 12-19 U/ml is indication of possible malignancy or inflammatory diseases

    Two weeks

Study Arms (1)

Positive ANCA

Patients with borderline positive ANCA results.

Other: Follow-up

Interventions

Follow-upOTHER

Follow-up of of patients with borderline positive ANCA test results

Positive ANCA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Patients with borderline positive ANCA test results

You may not qualify if:

  • Pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

Condition Hierarchy (Ancestors)

Systemic VasculitisVasculitisVascular DiseasesCardiovascular DiseasesSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nina Avshovich, MD

    Hillel Yaffe Medical Center

    STUDY DIRECTOR

  • Tatiana Sivan, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tatiana Sivan, MD

CONTACT

972-4-630-4648dk5@smile.net.il

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2014

First Posted

July 2, 2014

Study Start

August 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 2, 2014

Record last verified: 2014-07

Locations

IL(1)