Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism (NCT05961267) | Clinical Trial Compass
CompletedNot Applicable
Study of Gynecological Follow-up of Patients With Autoimmune Disease or Inflammatory Rheumatism
France318 participantsStarted 2023-07-24
Plain-language summary
Autoimmune diseases are the consequence of an abnormality of the immune system, leading it to attack components of our own body. They have a wide variety of presentations. They preferentially affect women, and often at a young age. Systemic lupus erythematosus, for example, most often occurs between the ages of 15 and 40.
Inflammatory rheumatism, such as spondyloarthritis or rheumatoid arthritis, is less prevalent in women, but also affects young people, and is particularly common.
Several disease-modifying treatments exist, depending on the severity and evolutivitý of the disease. Some are contraindicated or not recommended during pregnancy and therefore require supervision of pregnancy plans.
In addition, some treatments have an immunosuppressive activitý, which implies an annual screening of cervical lesions by cervico-uterine smear.
In this context, an adapted gynecological follow-up seems indispensable. The rheumatologist and the internist physician have a crucial role in advising and referring patients to their gynecological colleagues.
Studying the qualitý of this gynecological follow-up in a cohort of patients with autoimmune disease or inflammatory rheumatism is of major interest.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Female patient over 18 years of age
* Non-menopausal patient (only for the subgroup of patients used to assess the use of effective contraception)
* Patient with a diagnosis of systemic lupus erythematosus, Gougerot-Sjögren's syndrome, scleroderma, Sharp's syndrome, rheumatoid arthritis or spondyloarthritis, according to current international standards.
* French-speaking patient with no comprehension problems
* Person affiliated with or benefiting from a social securitý scheme
* Patient who received information about the protocol and gavé her consent
Exclusion Criteria:
* Pregnant or breastfeeding patient
* Patient with a history of total hysterectomy
* Patient referred to in articles L 1121-5 to L 1121-8 (persons deprived of liberty by a judicial or administrative decision, minors, adults subject to a legal protection measure or unable to express their consent).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is specifically about whether patients with conditions like mine — such as lupus, rheumatoid arthritis, or Sjögren's syndrome — are getting recommended cervical cancer screenings, can you tell me whether my autoimmune condition or the medications I take put me at higher risk for cervical dysplasia and whether my current screening schedule reflects that?
2This trial has already completed, so are there published findings I should know about that show how often patients with inflammatory rheumatic diseases are missing recommended cervical dysplasia screenings, and does that apply to my situation?
3Some immunosuppressive medications used for autoimmune diseases can affect the immune system's ability to fight HPV, which is linked to cervical dysplasia — does my specific treatment plan mean I should be screened more frequently than the standard recommendations?
4Given that this study tracked real-world gynecological follow-up in patients with conditions like mine, is my gynecological care being coordinated between my rheumatologist and my gynecologist, or could things like cervical screenings be falling through the cracks?
5Are there any international guidelines specific to patients with autoimmune diseases that my care team is following for cervical dysplasia screening, and if so, am I currently up to date with those recommendations?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients who report having a screening of cervical dysplasia during the year according to international recommendations.