Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Automated Reading of Anti-neutrophil Cytoplasmic Autoantibodies, Indispensable Markers of Vasculitis (ANCA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03640078
Recruitment Status : Not yet recruiting
First Posted : August 21, 2018
Last Update Posted : August 21, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

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.


Condition or disease Intervention/treatment Phase
Vascular Diseases Other: acquisition imaging Not Applicable

Detailed Description:

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. . From a valorisation point of view, this project could be the subject of a publication in an international scientific journal, a patent filing and an exploitation with an industrial partner.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Automated Reading of Anti-neutrophil Cytoplasmic Autoantibodies (ANCA), Indispensable Markers of Vasculitis
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vasculitis

Arm Intervention/treatment
Experimental: experimental group
Vasculitis 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)
Other: acquisition imaging
The usual care of the sera will not be modified, only a phase of acquisition of the images will be added to the analysis




Primary Outcome Measures :
  1. The number of positive ANCAs [ Time Frame: 1 day ]
    The number of positive ANCAs detected in order to automatically and reliably discriminate against positive ANCAs from negative ANCAs



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Vasculitis patients having signed a consent

Exclusion Criteria:

  • patients refusing to sign a consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03640078


Contacts
Layout table for location contacts
Contact: DANIEL BERTIN, MD +33 049386049 Daniel.BERTIN@ap-hm.fr

Locations
Layout table for location information
France
Assistance Publique Des Hopitaix de Marseille Not yet recruiting
Marseille, Paca, France, 13354
Contact: DANIEL BERTIN, MD    +33 491386049    Daniel.BERTIN@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Layout table for investigator information
Study Director: EMILIE GARRIDO PRADALIE APHM

Layout table for additonal information
Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03640078     History of Changes
Other Study ID Numbers: 2018-25
First Posted: August 21, 2018    Key Record Dates
Last Update Posted: August 21, 2018
Last Verified: August 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Diseases
Vasculitis
Cardiovascular Diseases
Autoantibodies
Immunologic Factors
Physiological Effects of Drugs