ClinicalTrials.gov record NCT07265999
Severity Factors of Dermatomyositis in the Caribbean Population - DM-ANTILLES
Severity Factors of Dermatomyositis in the Caribbean Population - DM-ANTILLES
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective observational study enrolls people newly diagnosed with dermatomyositis (age 16+) to describe disease features and severity at diagnosis. Participants are followed for two years to record outcomes such as death, relapse, and new cancer diagnoses. The study aims to find features present at diagnosis that are associated with more severe disease.
What it is studying. The study tests which features at diagnosis—muscle involvement causing functional disability; visceral involvement of the heart, lungs, or oropharyngeal region; or a cancer diagnosed within the past three years or at the same time—are associated with greater dermatomyositis severity and with later outcomes.
What the researchers hope to learn. To identify factors present at diagnosis that are associated with more severe dermatomyositis, to characterize the disease phenotype in the overseas/Caribbean population, and to record outcomes (mortality, relapses, and cancer occurrence) over two years.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
Dermatomyositis is a rare chronic autoimmune and inflammatory disease that affects the skin and striated muscles. Its prognosis is linked to visceral involvement (lungs, heart, and oropharyngeal region) and to the possible presence of associated cancer. The implementation of the research will allow identification of incident cases of dermatomyositis in Guadeloupe and the characterization of the disease in the overseas population, in the absence of data in the literature.
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Patient with a diagnosis of dermatomyositis according to the 2003 ENMC criteria
- Patient with parents or grandparents originating from the Caribbean arc
- Patient aged 16 years or older
- Patient residing in Guadeloupe
- Patient (or legal representative) who has received information about the study and has signed the informed consent form
- Patient affiliated with a social security scheme
Exclusion criteria
- Patient who started treatment with intravenous immunoglobulins, corticosteroids, or immunosuppressants within the month prior to the diagnosis of dermatomyositis
- Patient under legal protection (guardianship or trusteeship) or deprived of liberty
Study description and what participation involves
The study's detailed description, as published on ClinicalTrials.gov.
Detailed description from the registry
In the French West Indies, this condition is associated with high short- and medium-term morbidity and mortality. Diagnostic delays and patient care pathways may help explain this. However, a particularly severe phenotype of the disease in Antillean patients may also play a role, as observed in other autoimmune and inflammatory diseases we have described in overseas populations (e.g., systemic sclerosis, sarcoidosis). Identifying factors associated with the severity of dermatomyositis at the time of diagnosis would allow for the early implementation of a tailored management strategy to improve the disease prognosis in the target population.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will have a baseline assessment at diagnosis to record disease features and severity. The study will follow participants for up to two years with periodic clinical visits and review of medical information to record outcomes such as relapses, any cancer diagnoses, and survival. No experimental treatments are assigned—the study collects clinical data over time. Participants must provide informed consent before joining.
How the study is structured. A prospective, observational (case-only) study. People with a new dermatomyositis diagnosis join a single study group; researchers collect clinical information at diagnosis and follow participants for two years. No treatments are assigned by the study.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- The registry lists this study under Dermatomyositis. Does it apply to my diagnosis?
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in Guadeloupe. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on polymyositis
This trial is also listed on this site under dermatomyositis.
Important dates
- Study start
- Jul 16, 2021
- Primary completion
- Jul 16, 2029 (estimated)
- Study completion
- Jul 16, 2029 (estimated)
- Target enrollment
- 10 participants (estimated)
- Last updated on registry
- Dec 5, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Centre Hospitalier Universitaire de la Guadeloupe
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- melanie petapermal, Master degree 📞 +590590934667 ✉ melanie.petapermal@chu-guadeloupe.fr
- Valérie Hamony Soter 📞 +590590934677 ✉ valerie.soter@chu-guadeloupe.fr
Participating sites (1)
- CHU de la GuadeloupeRecruiting
Pointe-à-Pitre, 97139 · Guadeloupe
- nadège cordel, MD PhD · nadege.cordel@chu-guadeloupe.fr
Terms used on this page · explanations by MedicalUpdates.ai
- legal representative
- A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- corticosteroids
- Steroid medicines, such as prednisone, that reduce inflammation. Studies often require a stable dose at entry or measure whether the study treatment allows the dose to be reduced.
- immunosuppressants
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
← Back to clinical trials