SclerodermaNCT00213525
Genesis of Scleroderma: Role of Environmental Factors in 100 Patients With Scleroderma and 300 Controls
An observational study of Scleroderma, run by University Hospital, Rouen at 1 site in France.
Trial summary
Scleroderma is an autoimmune disease of unknown origin. Recently, the role of environmental factors, and particularly toxic drug exposure, in the genesis of scleroderma has been suggested. Read more about this study
- Who is it for?
- Ages 18 to 76 yearsHealthy volunteers can take part
- Conditions the study is for
- Scleroderma
- What is being tested?
- Questionnary for environmental factors research
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2004to Oct 2008
- 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 to 76 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 Patients With Scleroderma and 300 Healthy Controls
Who may be able to join
- patients with scleroderma with:
- age range : 18 to 76 years
- written consent
Who cannot join
- patients with other connective-tissue disorders
- pregnant women
- patients with psychiatric conditions
- unwritten consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genesis of Scleroderma: Role of Environmental Factors in 100 Patients With Scleroderma and 300 Healthy Controls
Scleroderma is an autoimmune disease of unknown origin. Recently, the role of environmental factors, and particularly toxic drug exposure, in the genesis of scleroderma has been suggested.
This prompted us to conduct this prospective, case-control, multicentric study, including 2 groups of subjects:
- 100 patients with scleroderma
- 300 sex- and age-matched healthy controls. The aim of our study is to determine whether exposure to toxics is higher in patients with scleroderma compared with healthy controls.
Read the detailed description
The data of patients with scleroderma and healthy controls will be compared regarding:
- a standardized questionnaire about "cursus laboris" at initial inclusion
- a search for toxics in blood, urine and hair: at initial exvaluation, 6 month and 2 year-follow-up
- Conditions
- Scleroderma
- Being tested
- Questionnary for environmental factors research
- Medical subject headings
- Scleroderma, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnary for environmental factors researchOther
Questionnary for environmental factors research
| Study group | Role | What they receive |
|---|---|---|
| Patients With Scleroderma | Assessments of questionnary for environmental factors research Receives: Other: Questionnary for environmental factors research | |
| Healthy Controls | Assessments of questionnary for environmental factors research Receives: Other: Questionnary for environmental factors research |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of environmental factor
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SclerodermaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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-control
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle MARIE, MD, PhD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00213525
- Sponsor's protocol ID
- 2002/039/HP
- Status last verified
- Feb 2015
- First submitted
- 13 Sep 2005
- Last updated
- 5 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genesis of Scleroderma: Role of Environmental Factors in 100 Patients With Scleroderma and 300 Healthy Controls
- ClinicalTrials.gov ID
- NCT00213525
- Acronym / sponsor ID
- 2002/039/HP
- Conditions
- Scleroderma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 21 Sep 2005 (estimated)
- 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.
Scleroderma is an autoimmune disease of unknown origin. Recently, the role of environmental factors, and particularly toxic drug exposure, in the genesis of scleroderma has been suggested.
This prompted us to conduct this prospective, case-control, multicentric study, including 2 groups of subjects:
- 100 patients with scleroderma
- 300 sex- and age-matched healthy controls. The aim of our study is to determine whether exposure to toxics is higher in patients with scleroderma compared with healthy controls.
Detailed description
The data of patients with scleroderma and healthy controls will be compared regarding:
- a standardized questionnaire about "cursus laboris" at initial inclusion
- a search for toxics in blood, urine and hair: at initial exvaluation, 6 month and 2 year-follow-up
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients With Scleroderma | – | Other: Questionnary for environmental factors researchAssessments of questionnary for environmental factors research |
| Healthy Controls | – | Other: Questionnary for environmental factors researchAssessments of questionnary for environmental factors research |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 Patients With Scleroderma and 300 Healthy Controls
Key inclusion criteria (3 listed)
- patients with scleroderma with:
Key exclusion criteria (4 listed)
- patients with other connective-tissue disorders
- pregnant women
- patients with psychiatric conditions
- unwritten consent
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 |
|---|---|---|
| Questionnary for environmental factors researchQuestionnary for environmental factors research | Other | Healthy Controls, Patients With Scleroderma |
Primary outcome
Identification of environmental factor
Time frame: Day 1
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 5 Feb 2015.
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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.
Isabelle MARIE, MD, PhD principal investigator
University Hospital, Rouen
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 Scleroderma, run by University Hospital, Rouen 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 3 inclusion and 4 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 5 Feb 2015. 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?
Identification of environmental factor (time frame: Day 1). 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 5 Feb 2015.