ANCA Associated VasculitisANCAPRONCT05416723
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 of ANCA Associated Vasculitis and Occupational Diseases, run by University Hospital, Brest at 11 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ANCA Associated Vasculitis, Occupational Diseases, Environmental Exposure
- How many people
- 302 participants
- Where
- 11 sitesFrance
- Study dates
- 1 Jul 2022to 1 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ANCA vasculitis seen in French occupational disease consultation centres.
Who may be able to join
- 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
Who cannot join
- Refusal to participate
Trial locations and contacts
11 sites in 1 country.
Brice LODDE contact
11 sites in 1 country
France11 sites
CHU de Bordeaux
Bordeaux
Esquer Catherine, Catherine.verdun-esquer@chu-bordeaux.fr
CHU de Grenoble
Grenoble
Bonneterre Vincent, VBonneterre@chu-grenoble.fr
CHU de LILLE
Lille
Nisse Catherine, catherine.nisse@nordnet.fr
HCL
Lyon
Charbotel Barbara, barbara.charbotel-coing-boyat@univ-lyon1.fr
AP-HM
Marseille
Lehucher Marie-Pascale, Marie-pascale.LEHUCHER@ap-hm.fr
CHU de Nancy
Nancy
Thaon Isabelle, i.thaon@chru-nancy.fr
CHU de Nantes
Nantes
Tripodi Dominique, Dominique.tripodi@chu-nantes.fr
Hôpital Cochin ( AP-HP)
Paris
Lynda Bensefas-Colas, lynda.bensefa-colas@aphp.fr
CHU de Rennes
Rennes
Paris Christophe, Christophe.PARIS@chu-rennes.fr
CHU de Strasbourg
Strasbourg
Gonzalez Maria, Maria.Gonzalez@chru-strasbourg.fr
CHU de Toulouse
Toulouse
Esquirol Yolande, esquirol.y@chu-toulouse.fr
About this study
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.
- Medical subject headings
- Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Occupational Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (4)
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Jul 2022 (estimated)
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ANCA Associated VasculitisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 302 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416723
- Sponsor's protocol ID
- ANCAPRO (29BRC22.0035)
- Acronym
- ANCAPRO
- Status last verified
- Apr 2022
- First submitted
- 9 Jun 2022
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational and Environmental Origins of ANCA Vasculitis: Contribution of Data From the National Network for Vigilance and Prevention of Occupational Pathologies (RNV3P)
- ClinicalTrials.gov ID
- NCT05416723
- Acronym / sponsor ID
- ANCAPRO / ANCAPRO (29BRC22.0035)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 302 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Jul 2022 (estimated)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 13 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ANCA vasculitis seen in French occupational disease consultation centres.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of diagnoses of ANCA vasculitis in the RNV3P
Time frame: 4 months
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 secondary outcomes
Imputability of the coded diagnoses of ANCA vasculitis.
Time frame: 4 months
Number of patients with ANCA vasculitis for whom occupational and/or environmental exposure to microcrystalline silica was identified.
Time frame: 4 months
Number of patients with ANCA vasculitis for whom other occupational and/or environmental exposure was identified.
Time frame: 4 months
Number of patients with ANCA vasculitis for whom an application for recognition as a disabled worker has been submitted.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication
Related trials for ANCA Associated Vasculitis
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
Active, not recruitingPhase 2
Safety and Efficacy of Tarperprumig in Adult Participants With Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis
Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
RecruitingPhase 1/2
A Phase 1/2 Study of NKX019 in Subjects With Immune-Mediated Diseases (Ntrust-2)
Systemic Sclerosis, Idiopathic Inflammatory Myopathies
Not yet recruitingPhase 2
Trial of VIS954 in the Treatment of Antineutrophil Cytoplasmic Antibody-associated Vasculitis
Antineutrophil Cytoplasmic Antibody-associated Vasculitis
RecruitingObservational study
Studies of the Natural History, Pathogenesis, and Outcome of Idiopathic Systemic Vasculitis
Takayasu's Arteritis, Giant Cell Arteritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brice LODDE contact
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ANCA Associated Vasculitis and Occupational Diseases, run by University Hospital, Brest at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Greta GOURIER (0298223509, greta.gourier@chu-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of diagnoses of ANCA vasculitis in the RNV3P (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.