Systemic SclerosisVISSEXPOSITIONNCT03543956
Professional and Personal Toxic Exposure in Systemic Sclerosis : Type, Intensity and Probability of Exposition
An observational study of Systemic Sclerosis, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Systemic Sclerosis (SSc) is an inflammatory chronic disease that can lead to structural damage and handicap. The SSc physiopathology is multifactorial, including genetic and environmental risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 226 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2018to 27 Jun 2019
- 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 affected by SSc according to EULAR 2013 criteria.
Who may be able to join
- Patients aged over 18 years old
- Speaking and understanding French language
- Being informed about the study and having given his consent
- Affected by SSc according to EULAR 2013 criteria
Who cannot join
- Patient under tutorship
- Patient who refuse to participate
Trial locations and contacts
1 site in 1 country.
About this study
Systemic Sclerosis (SSc) is an inflammatory chronic disease that can lead to structural damage and handicap. The SSc physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the SSc mechanism, and improves the diagnosis and the treatment of the disease.
Read the detailed description
Studies show that the risk associated with high cumulative exposure to silica and organic solvents appears to be strongly increased in SSc. Moreover, exposure to silica is associated with a specific type of SSc phenotype with a worse prognosis. However, the type, intensity and probability of these expositions are unknown.
The aim of the study is to precisely determine type, intensity and probability of toxic substances exposition in Systemic Sclerosis patients through an auto-questionnaire and integration of these data in a computer matrix.
- Conditions
- Systemic Sclerosis
- Being tested
- Questionnaire
- Keywords
- Silica, Organic Solvents, Toxic substances exposure
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireBehavioural
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Systemic Sclerosis patient | patients affected by SSc according to EULAR 2013 criteria Receives: Behavioral: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyse type, intensity and probability of toxic substances exposition in Systemic Sclerosis patients through an auto-questionnaire and integration of these data in a computer matrix
Measured: At baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2018
- Study start4 Jun 2018
- Primary completion27 Jun 2019
- Study completion27 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Elise TRUCHETET, MD, PhD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03543956
- Sponsor's protocol ID
- CHUBX 2018/09
- Acronym
- VISSEXPOSITION
- Status last verified
- Sep 2019
- First submitted
- 18 May 2018
- Last updated
- 11 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Galli G, De Pous-Gerardin C, Hanguehard R, Berthy F, Le Moal C, Lourde C, Barnetche T, Skopinski S, Contin-Bordes C, Delva F, Carles C, Truchetet ME. Occupational quantitative exposure to crystalline silica, solvents and pesticides and risk of clinical forms of systemic sclerosis. Rheumatology (Oxford). 2024 Dec 1;63(12):3397-3406. doi: 10.1093/rheumatology/kead602.
PubMed 37963059
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Professional and Personal Toxic Exposure in Systemic Sclerosis : Type, Intensity and Probability of Exposition
- ClinicalTrials.gov ID
- NCT03543956
- Acronym / sponsor ID
- VISSEXPOSITION / CHUBX 2018/09
- Conditions
- Systemic Sclerosis
- Keywords
- Silica, Organic Solvents, Toxic substances exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 27 Jun 2019 (actual)
- Study completion
- 27 Jun 2019 (actual)
- First posted
- 1 Jun 2018 (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.
Systemic Sclerosis (SSc) is an inflammatory chronic disease that can lead to structural damage and handicap. The SSc physiopathology is multifactorial, including genetic and environmental risk factors. The identification of environmental factors implication is crucial to understand the SSc mechanism, and improves the diagnosis and the treatment of the disease.
Detailed description
Studies show that the risk associated with high cumulative exposure to silica and organic solvents appears to be strongly increased in SSc. Moreover, exposure to silica is associated with a specific type of SSc phenotype with a worse prognosis. However, the type, intensity and probability of these expositions are unknown.
The aim of the study is to precisely determine type, intensity and probability of toxic substances exposition in Systemic Sclerosis patients through an auto-questionnaire and integration of these data in a computer matrix.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Systemic Sclerosis patient | – | Behavioral: Questionnairepatients affected by SSc according to EULAR 2013 criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients affected by SSc according to EULAR 2013 criteria.
Key inclusion criteria (4 listed)
- Patients aged over 18 years old
- Speaking and understanding French language
- Being informed about the study and having given his consent
- Affected by SSc according to EULAR 2013 criteria
Key exclusion criteria (2 listed)
- Patient under tutorship
- Patient who refuse 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QuestionnaireQuestionnaire | Behavioural | Systemic Sclerosis patient |
Primary outcome
Analyse type, intensity and probability of toxic substances exposition in Systemic Sclerosis patients through an auto-questionnaire and integration of these data in a computer matrix
Time frame: At baseline (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2019.
- Derived from this study: PubMed 37963059Galli G, De Pous-Gerardin C, Hanguehard R, Berthy F, Le Moal C, Lourde C, Barnetche T, Skopinski S, Contin-Bordes C, Delva F, Carles C, Truchetet ME. Occupational quantitative exposure to crystalline silica, solvents and pesticides and risk of clinical forms of systemic sclerosis. Rheumatology (Oxford). 2024 Dec 1;63(12):3397-3406. doi: 10.1093/rheumatology/kead602.
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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.
Marie-Elise TRUCHETET, MD, PhD principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis, run by University Hospital, Bordeaux at 1 site 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 11 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analyse type, intensity and probability of toxic substances exposition in Systemic Sclerosis patients through an auto-questionnaire and integration of these data in a computer matrix (time frame: At baseline (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03543956, which also lists 1 linked publication.
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 11 Sep 2019; AzTrials last refreshed its copy on 6 Nov 2026.