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

Environmental Exposure Clinical Trial

— ANCAPRO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05416723
• Other study ID #: ANCAPRO (29BRC22.0035)
• Status: Not yet recruiting
• Start date: July 1, 2022
• Est. completion date: August 1, 2022

Study information

• Verified date: April 2022
• Source: University Hospital, Brest
• Contact: Greta GOURIER
• Phone: 0298223509
• Email: greta.gourier[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 302
• Est. completion date: August 1, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Refusal to participate

Related Conditions & MeSH terms

• ANCA Associated Vasculitis
• Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
• Environmental Exposure
• Occupational Diseases
• Vasculitis

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux
France	CHU de Grenoble	Grenoble
France	CHU de LILLE	Lille
France	HCL	Lyon
France	AP-HM	Marseille
France	CHU de Nancy	Nancy
France	CHU de Nantes	Nantes
France	Hôpital Cochin ( AP-HP)	Paris
France	CHU de Rennes	Rennes
France	CHU de Strasbourg	Strasbourg
France	CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Imputability of the coded diagnoses of ANCA vasculitis.	Number of patients with ANCA vasculitis seen in consultation in occupational disease consultation centres for which a link between occupational and/or environmental exposure and the patient's ANCA vasculitis was retained. The imputability is coded in the RNV3P database by the clinician who saw the patient, for each exposure recorded in the database, according to the pathology selected and the patient's exposure following the completion of the patient's laboris and environmental curriculum.	4 months
Secondary	Number of patients with ANCA vasculitis for whom occupational and/or environmental exposure to microcrystalline silica was identified.	Number of patients with ANCA vasculitis seen in consultation in occupational disease consultation centres for whom occupational and/or environmental exposure to microcrystalline silica was identified.	4 months
Secondary	Number of patients with ANCA vasculitis for whom other occupational and/or environmental exposure was identified.	Number of patients with ANCA vasculitis seen in consultation in occupational disease consultation centres for whom other occupational and/or environmental exposure was identified.	4 months
Secondary	Number of patients with ANCA vasculitis for whom an application for recognition as a disabled worker has been submitted.	Number of patients with ANCA vasculitis seen in consultation in occupational disease consultation centres for whom an application for recognition as a disabled worker has been submitted.	4 months