CClinicalTrials.gg
Status unknownNCT05416723ANCAPROUpdated Jun 13, 2022

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

An observational study in ANCA Associated Vasculitis, Occupational Diseases and Environmental Exposure, sponsored by University Hospital, Brest. Status unknown at 11 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-13.

Sponsored by University Hospital, Brest · Observational

The sponsor has not verified this record recently (last verified Apr 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
302
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • ANCA Associated Vasculitis
  • Occupational Diseases
  • Environmental Exposure
03

In context

Vasculitis

230 studies on the registry are indexed under Vasculitis; 68 are open to participants now.

This study's planned enrollment of 302 is above the median of 149 across 104 observational studies indexed under Vasculitis.

Browse Vasculitis studies →

Lead sponsor

University Hospital, Brest is the lead sponsor of 594 studies on the registry; 135 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

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

Exclusion Criteria:

  • Refusal to participate
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
302 participants (estimated)
Patient registry
No
06

What researchers measure

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.

    Time frame: 4 months

Secondary outcomes

  1. 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.

    Time frame: 4 months

  2. 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.

    Time frame: 4 months

  3. 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.

    Time frame: 4 months

  4. 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.

    Time frame: 4 months

07

Study locations

11 sites
08

References and documents

Individual participant data

Plan to share: Yes — All collected data that underlie results in a publication

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05416723
Lead sponsor
University Hospital, Brest
Responsible party
Sponsor
First posted
Jun 13, 2022
Start date
Jul 1, 2022 (estimated)
Primary completion
Jul 1, 2022 (estimated)
Completion
Aug 1, 2022 (estimated)
Last update
Jun 13, 2022

Study contacts

Greta GOURIER
Contact
greta.gourier@chu-brest.fr
0298223509
Brice LODDE
Contact
brice.lodde@chu-brest.fr

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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