Automated Reading of Anti-neutrophil Cytoplasmic Autoantibodies, Indispensable Markers of Vasculitis
ANCA
1 other identifier
interventional
2,000
1 country
1
Brief Summary
Neutrophil cytoplasmic autoantibodies (ANCA) are essential serum markers in the diagnosis of vasculitis. Indirect immunofluorescence with microscope reading by two readers is the reference technique for their detection. In the AP-HM immunology laboratory we are looking for ANCAs in more than 7000 sera per year. The reading of the slides is time-consuming, dependent operator, and lacks standardization. In order to optimize these parameters, we propose the automation of ANCA reading by using a robotic platform developed in our laboratory and called ICARE (Immunofluorescence for Computed Antibodies Rational Evaluation). This microscopic imaging platform with automated reading is currently used in daily routine for the detection of anti-nuclear autoantibodies. The objective of the project is to establish an algorithm allowing i) to automatically and reproducibly discriminate the positive ANCAs from the negative ANCAs and ii) to propose to the biologist a fluorescence aspect. The investigators will then validate this algorithm on 2000 consecutive routine samples sent to the laboratory for ANCA research. The usual care will not be changed, only a phase of acquisition of the images will be added to the analysis. The investigators expect to use this algorithm "ICARE / ANCA" in daily hospital routine and thus optimize the results with a real economic impact is 50% less reading time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 17, 2018
CompletedFirst Posted
Study publicly available on registry
August 21, 2018
CompletedStudy Start
First participant enrolled
October 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2021
CompletedAugust 21, 2018
August 1, 2018
2 years
August 17, 2018
August 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The number of positive ANCAs
The number of positive ANCAs detected in order to automatically and reliably discriminate against positive ANCAs from negative ANCAs
1 day
Study Arms (1)
experimental group
EXPERIMENTALVasculitis patients The usual care of the sera will not be modified, only a phase of acquisition of the images will be added to the analysis of serum. (acquisition imaging)
Interventions
The usual care of the sera will not be modified, only a phase of acquisition of the images will be added to the analysis
Eligibility Criteria
You may qualify if:
- Vasculitis patients having signed a consent
You may not qualify if:
- patients refusing to sign a consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique Des Hopitaix de Marseille
Marseille, PACA, 13354, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
EMILIE GARRIDO PRADALIE
APHM
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 17, 2018
First Posted
August 21, 2018
Study Start
October 1, 2018
Primary Completion
October 1, 2020
Study Completion
April 1, 2021
Last Updated
August 21, 2018
Record last verified: 2018-08