National Cohort of Patients With SITRAME Syndrome

NCT ID: NCT07168746

Last Updated: 2025-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-30

Study Completion Date

2055-09-30

Brief Summary

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SITRAME syndrome is a recently described disease. In the absence of epidemiological data on SITRAME syndrome in France, the National Reference Center for Autoinflammatory Diseases proposes coordinating a database to collect both retrospective and prospective cases of this rare disease.

Currently, there are no available data on the epidemiology or treatment of SITRAME syndrome in France or globally. The importance of this research is to provide an overview of demographic, etiological, and disease progression data for patients with SITRAME syndrome in France. This will allow the establishment of quantitative data on the morbidity and mortality of this rare disease.

Detailed Description

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Conditions

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Auto Inflammatory Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

• SITRAME syndrome meeting the diagnostic criteria for the disease

All the following criteria must be met:

1. Systemic inflammation: at least 1 documented episode of CRP \>5mg/mL during a skin flare
2. Maculopapular rash on the trunk: fixed, non-itchy maculopapular rash on the trunk appearing within hours with clear borders
3. Recurrence in the same areas: at least 3 different episodes
4. Acute: duration less than 8 days

And at least 1 of the following criteria:

1. Fever during flare-ups
2. Flare-ups triggered by infections, vaccinations, or intense physical exercise
3. Fatigue during and/or after flare-ups
4. Associated papular rash

Exclusion Criteria

* No evidence of a monogenic autoinflammatory disease, evolving neoplasm, or evolving autoimmune disease.
* Adult patients at the time of inclusion
* Patients not opposed to participating in the research


\- Persons with special protection cannot be included in the study:

* Adults under guardianship or curatorship
* Hospitalized persons without consent and not legally protected
* Persons deprived of liberty
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angele SORIA, PUPH, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Central Contacts

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Angele SORIA, PU-PH, MD, PhD

Role: CONTACT

00 33 1 56 01 72 20

Sophie GEORGIN-LAVIALLE, PUPH, MD, PhD

Role: CONTACT

00 33 1 56 01 74 31

Other Identifiers

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APHP250008

Identifier Type: -

Identifier Source: org_study_id

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