Severity Factors of Dermatomyositis in the Caribbean Popu... | NCT07265999

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

NCT07265999

Sponsor

Centre Hospitalier Universitaire de la Guadeloupe

Status

Recruiting

Last Update Posted

Dec 5, 2025Actual

Enrollment

10Estimated

Phase

Not provided

Conditions

Dermatomyositis

Interventions

Not provided

Countries

Guadeloupe

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 16, 2021Actual

Primary Completion Date

Jul 16, 2029Estimated

Completion Date

Jul 16, 2029Estimated

First Submitted Date

Nov 14, 2025

First Submission Date that Met QC Criteria

Dec 3, 2025

First Posted Date

Dec 5, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 3, 2025

Last Update Posted Date

Dec 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10Estimated

Label	Type	Description	Intervention Names
Patients with dermatomyositis		All patient with dermatomyositis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Assessed at baseline (diagnosis).

Secondary Outcomes

Measure	Description	Time Frame
Mortality	Number of participants who die from any cause during the follow-up period. Units: Count of participants	Assessed over 2 years from the date of dermatomyositis diagnosis
Relapse Occurrence

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
melanie petapermal, Master degree	Contact	+590590934667		melanie.petapermal@chu-guadeloupe.fr
Valérie Hamony Soter	Contact	+590590934677		valerie.soter@chu-guadeloupe.fr

Overall Officials

Name	Affiliation	Role
nadège cordel, MD PhD	CHU de la Guadeloupe	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de la Guadeloupe	Recruiting	Pointe-à-Pitre		97139	Guadeloupe

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003882	Dermatomyositis

Ancestor Terms

ID	Term
D017285	Polymyositis
D009220	Myositis
D009135	Muscular Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Description

Additional blood samples required for research, including HLA typing and serum interferon assays, will consist of up to three 3.5 mL dry tubes and one 5 mL EDTA tube (total 15.5 mL).

HLA typing samples (1 × 5 mL EDTA tube) will be transported internally to the CHU Guadeloupe Immuno-Hematology Laboratory for processing.

Serum interferon samples (3 × 3.5 mL tubes) will be sent to the CHU Guadeloupe Biobank (CRB), centrifuged, aliquoted into cryotubes, and stored at -80 °C until batch shipment to the processing site.