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RecruitingNCT07265999DM-ANTILLESUpdated Dec 5, 2025

Severity Factors of Dermatomyositis in the Caribbean Population - DM-ANTILLES

An observational study in Dermatomyositis, sponsored by Centre Hospitalier Universitaire de la Guadeloupe. Recruiting at 1 site in Guadeloupe. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2025-12-05.

Sponsored by Centre Hospitalier Universitaire de la Guadeloupe · Observational

From the registry’s dates

  • Started Jul 2021; still recruiting 5 years 3 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
10
Ages
16 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Dermatomyositis

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Keywords

  • Dermatomyositis
03

In context

Dermatomyositis

184 studies on the registry are indexed under Dermatomyositis; 63 are open to participants now.

This study's planned enrollment of 10 is below the median of 179 across 45 observational studies indexed under Dermatomyositis.

Browse Dermatomyositis studies →

Lead sponsor

Centre Hospitalier Universitaire de la Guadeloupe is the lead sponsor of 50 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The study population consists of patients (>16 years old) diagnosed with dermatomyositis, including both classic dermatomyositis and clinically amyopathic dermatomyositis, regardless of sex or ethnicity. Eligible patients are those who have received a new diagnosis and can be followed for at least two years.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 form
  • Patient affiliated with a social security scheme

Exclusion criteria

Exclusion Criteria:

  • Patient who started treatment with intravenous immunoglobulins, , or within the month prior to the diagnosis of dermatomyositis
  • Patient under legal protection (guardianship or trusteeship) or deprived of liberty
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Patients with dermatomyositis

    All patient with dermatomyositis

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What researchers measure

Primary outcomes

  1. severity of dermatomyositis at diagnosis

    The primary outcome measure is the severity of dermatomyositis at diagnosis, defined by the presence of one or more of the following criteria: Muscle involvement resulting in functional disability; Associated visceral involvement, including the heart, lungs, or oropharyngeal region; Associated cancer, either previously diagnosed within the past three years or diagnosed concurrently with dermatomyositis.

    Time frame: Assessed at baseline (diagnosis).

Secondary outcomes

  1. Mortality

    Number of participants who die from any cause during the follow-up period. Units: Count of participants

    Time frame: Assessed over 2 years from the date of dermatomyositis diagnosis

  2. Relapse Occurrence

    Number of participants experiencing relapse(s) during treatment tapering or after treatment discontinuation. Units: Count of participants

    Time frame: Assessed over 2 years from the date of dermatomyositis diagnosis

  3. Cancer Occurrence

    Number of participants diagnosed with any cancer during the follow-up period. Units: Count of participants

    Time frame: Assessed over 2 years from the date of dermatomyositis diagnosis

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Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07265999
Lead sponsor
Centre Hospitalier Universitaire de la Guadeloupe
Responsible party
Sponsor
First posted
Dec 5, 2025
Start date
Jul 16, 2021
Primary completion
Jul 16, 2029 (estimated)
Completion
Jul 16, 2029 (estimated)
Last update
Dec 5, 2025

Study contacts

melanie petapermal, Master degree
Contact
melanie.petapermal@chu-guadeloupe.fr
+590590934667
Valérie Hamony Soter
Contact
valerie.soter@chu-guadeloupe.fr
+590590934677
nadège cordel, MD PhD
principal investigator · CHU de la Guadeloupe

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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