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Идёт набор NCT07345052

Western Sweden Systemic Sclerosis Project

— Наблюдательное Scleroderma, Systemic Fibrosis; Skin Fibrosis Lung Interstitial Lung Disease Due to Systemic Disease

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
В протоколе указаны: No Intervention: Observational Cohort.
Кому может быть актуально
Состояния в реестре: Scleroderma, Systemic, Fibrosis; Skin, Fibrosis Lung, Interstitial Lung Disease Due to Systemic Disease. 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
Швеция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Western Sweden Systemic Sclerosis Project - A Study on Underlying Mechanisms for Disease Development and Predictors of Disease Activity and Treatment Response in Patients With Systemic Sclerosis

Обзор

The main aim of the project is to identify key-factors involved in the development and progression of Systemic Sclerosis (SSc), a chronic invalidating rheumatic disease characterized by high mortality and insufficient treatment options. A cohort of patients with SSc will be collected at the Sahlgrenska University Hospital in Gothenburg, Skaraborg Hospital in Skövde, and Södra Älvsborg Hospital in Borås (Sweden). Thanks to a holistic approach including integrated analysis of blood, and skin samples as well as DNA, and with the use of state-of-the-art methods, this project aims to identify factors (e.g. genes, proteins, metabolites, and immune cell types) associated with the development of SSc and with the progression to a more aggressive phenotype. Functional studies using in vitro model systems and patient specimens will be also implemented. The findings of the current project could lead to the identification of possible diagnostic and prognostic markers for the disease as well as potential drug targets. This cohort will be also linked to the European Scleroderma Trial and Research (EUSTAR), which is an international SSc research network aiming to coordinate research activities on SSc from groups all over Europe in order to improve treatment, quality of life and mortality of patients with SSc.

Вмешательства

  • Другое No Intervention: Observational Cohort
    no intervention

Первичные конечные точки

  • Predictors of disease activity and progression in plasma samples [Срок оценки: The analyses will be performed in the entire study cohort at inclusion (including healthy subjects) and at the 2- and 5-year FU for patients with SSc.]
Вторичные конечные точки (9)
  • Genetic markers of progression to an aggressive phenotype in subjects with SSc [Срок оценки: Baseline DNA]
  • Characterisation of skin cells in relation to SSc pathogenesis and progression [Срок оценки: The analyses will be performed in the entire study cohort at inclusion (including healthy subjects) and at the 2- and 5-year FU for patients with SSc.]
  • Memory B cell compartment and prognosis of SSc [Срок оценки: Baseline PBMCs]
  • PBMCs subsets and activation in the pathogenesis of SSc. [Срок оценки: Baseline, 2- and 5- years FU]
  • Circulating fibrocytes and pathogenesis of SSc. [Срок оценки: Baseline, 2- and 5- years FU]
  • Arthritis involvement in SSc. [Срок оценки: Baseline, 2- and 5-years follow up]
  • Assessment of Lung Function and Biomarker Profiling in Patients with Systemic Sclerosis through PExA sampling [Срок оценки: Up to 2 years]
  • Assessment of Lung Function in Patients with Systemic Sclerosis through Insert Gas Washout [Срок оценки: Up to 2 years]
  • Assessment of Lung Function in Patients with Systemic Sclerosis through Impulse Oscillometry [Срок оценки: Up to 2 years]

Критерии участия

Критерии включения

  • Participants diagnosed with SSc according to the ACR and EULAR classification criteria

Критерии исключения

  • Diagnosis of Mixed connective tissue disease
  • Not speaking or reading Swedish
  • With severe cognitive impairment
  • With blood count below specified limits
  • Allergy to local anaesthetic (for subjects who will provide a skin biopsy)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

Швеция · 1 центр
  • Rheumatology clinics, Sahlgrenska University Hospital — Gothenburg

Идентификаторы

NCT: NCT07345052 · WESST

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗