Occupational and Environmental Origins of ANCA Vasculitis: Contribution of Data From the National Network for Vigilance and Prevention of Occupational Pathologies (RNV3P)

NCT05416723 | Unknown

• 1 other identifier: ANCAPRO (29BRC22.0035)
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 11

Brief Summary

The main objective is to identify specific risk factors for ANCA vasculitis of occupational and/or environmental origin (exposures identified by questioning, geographical distribution of cases) from the RNV3P data. The secondary objectives are as follows:

• Description of cases of ANCA vasculitis seen in French occupational pathology consultation centres:
• reasons for consultation,
• occupational and environmental etiologies described
• occupational situations responsible
• aptitude notices
• recognition as an occupational disease
• Identification of specific risk factors for ANCA vasculitis of occupational and/or environmental origin (exposures identified on questioning, geographical distribution of cases).
• For occupational and non-occupational cases of ANCA vasculitis: identification of difficulties encountered by patients at work and proposed work adaptations.
• Estimation of the number of applications for recognition of disabled worker status made within this patient group.
• Identification of clinical severity and autoimmune profiles of ANCA vasculitis of occupational and/or environmental origin.

Conditions

ANCA Associated Vasculitis; Occupational Diseases; Environmental Exposure

Outcome Measures

Primary Outcomes (1)

• Number of diagnoses of ANCA vasculitis in the RNV3P

  Number of diagnoses of ANCA vasculitis coded in the RNV3P or mentioned as the disease motivating the consultation in the summary by text mining search.

  4 months

Secondary Outcomes (4)

• Imputability of the coded diagnoses of ANCA vasculitis.

  4 months

• Number of patients with ANCA vasculitis for whom occupational and/or environmental exposure to microcrystalline silica was identified.

  4 months

• Number of patients with ANCA vasculitis for whom other occupational and/or environmental exposure was identified.

  4 months

• Number of patients with ANCA vasculitis for whom an application for recognition as a disabled worker has been submitted.

  4 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with ANCA vasculitis seen in French occupational disease consultation centres.

You may qualify if:

• Patient with ANCA vasculitis defined according to the International Classification of Diseases (ICD-10), i.e. M 308, M 31, N 057 and L 95, or mentioned as the reason for consultation in the text mining summary.
• Seen in consultation in the occupational disease consultation centres belonging to the RNV3P
• No opposition

You may not qualify if:

• Refusal to participate

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (11)

CHU de Bordeaux

Bordeaux, France

Location

CHU de Grenoble

Grenoble, France

Location

CHU de LILLE

Lille, France

Location

HCL

Lyon, France

Location

AP-HM

Marseille, France

Location

CHU de Nancy

Nancy, France

Location

CHU de Nantes

Nantes, France

Location

Hôpital Cochin ( AP-HP)

Paris, France

Location

CHU de Rennes

Rennes, France

Location

CHU de Strasbourg

Strasbourg, France

Location

CHU de Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Occupational Diseases

Condition Hierarchy (Ancestors)

Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Greta GOURIER

CONTACT

0298223509; greta.gourier@chu-brest.fr

Brice LODDE

CONTACT

brice.lodde@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 13, 2022
• Study Start: July 1, 2022
• Primary Completion: July 1, 2022
• Study Completion: August 1, 2022
• Last Updated: June 13, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available beginning 3 months and ending five years following the publication
• Access Criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations

FR (11)