Набор скоро начнётся NCT07168746

National Cohort of Patients With SITRAME Syndrome

— Наблюдательное Auto Inflammatory Diseases

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально: Состояния в реестре: Auto Inflammatory Diseases. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Список центров уточняется — проверьте первичный протокол.
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

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.

Первичные конечные точки

Description of the sexe at the diagnosis of the disease in order to describe the clinical characteristics of patients followed for SITRAME syndrome [Срок оценки: Day 0- Baseline]
Description of the age at the diagnosis of the disease [Срок оценки: Day 0- Baseline]
Description of cardiovascular co-morbidity [Срок оценки: Day 0- Baseline]
Description of presence of an allergical context [Срок оценки: Day 0- Baseline]
Description of the different therapeutic lines [Срок оценки: Year 15]
Description of the age at death [Срок оценки: Day 0- Baseline]

Вторичные конечные точки (12)

Measure of the prevalence of this disease annually using the register of newly included patients [Срок оценки: Every year up to 15 years]
Measure of the incidence of this disease [Срок оценки: Every year up to 15 years]
Description of the rare clinical manifestations (outside of the well-established disease criteria) [Срок оценки: Year 15]
Description of the rare biological manifestations (outside of the well-established disease criteria) [Срок оценки: Year 15]
Measure of the number of patients eligible for various clinical research studies on SITRAME syndrome [Срок оценки: Every year up to 15 years]
Measure of the proportion of patients using targeted therapies throughout the study [Срок оценки: Year 15]
Measure of the number of deaths in patients followed for SITRAME syndrome [Срок оценки: every 5 years up to 15 years]
Description of the death causes in patients followed for SITRAME syndrome [Срок оценки: every 5 years up to 15 years]
Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (pulmonary manifestations) [Срок оценки: every 5 years up to 15 years]
Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (cardiac manifestations) [Срок оценки: Every 5 years up to 15 years]
Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (neurological manifestations) [Срок оценки: every 5 years up to 15 years]
Number of dead patients followed for SITRAME syndrome with presence and pattern of extracutaneous involvement (gastrointestinal manifestations) [Срок оценки: every 5 years up to 15 years]

Критерии участия

Критерии включения

SITRAME syndrome meeting the diagnostic criteria for the disease

All the following criteria must be met:

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

And at least 1 of the following criteria:

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

And all the following exclusion criteria must be met:

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