Longitudinal Study for Central Nervous System Vasculitis
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: Central Nervous System Vasculitis, CNS Vasculitis, CNSV, Vasculitis. 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
- США, Канада
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
Primary central nervous system vasculitis (CNSV) is a potentially fatal, single-organ vasculitis that often involves a spectrum of neurologic complications, including strokes, cognitive and speech impairment, visual loss, dementia, and encephalopathy. The purpose of this study is to establish a research cohort to investigate the disease process, treatments, and patient outcomes in CNSV.
Подробное описание
Primary central nervous system vasculitis (CNSV) is a potentially fatal, single-organ vasculitis that often involves a spectrum of neurologic complications, including strokes, cognitive and speech impairment, visual loss, dementia, and encephalopathy. Originally described in the early 1950s, research in the disease has been slow to progress, largely limited by the rarity of the disease and the lack of biologic materials for basic and translational investigations. To date, the bulk of research in the field has been clinical, largely consisting of retrospective case series, predominately from single sites, focusing on correlations among clinical, imaging, and histopathology data. Collectively these series suggest the existence of clinically-relevant subsets. Such studies, while enhancing our knowledge of this rare disease, are limited by small numbers of patients (especially those confirmed by histopathology), and the near absence of detailed investigations into the biomolecular and immunopathogenic basis of the disease.
Development of this longitudinal cohort and multicenter approach offers the potential to generate new insights, generate new questions, and further our understanding of its natural history, pathophysiology, genetic basis, and discovery of biomarkers to assess disease activity and prognosis.
Study visits will occur every 3 months for this first year, and then annually for two more years. Blood collection will occur at every visit. A physical exam and medical and medication history will at every visit; also, participants will be asked to complete several questionnaires to assess disease activity, health status, and tobacco, alcohol, and drug use.
Первичные конечные точки
- Evaluate the pathogenesis of central nervous system vasculitis using disease history. [Срок оценки: Study completion; from baseline through month 36.]
Вторичные конечные точки (8)
- PROMIS Questionnaires [Срок оценки: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36]
- PROMIS Questionnaires [Срок оценки: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36]
- PROMIS Questionnaires [Срок оценки: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36]
- PROMIS Questionnaires [Срок оценки: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36]
- PROMIS Questionnaires [Срок оценки: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36]
- PROMIS Questionnaires [Срок оценки: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36]
- PROMIS Questionnaires [Срок оценки: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36]
- PROMIS Questionnaires [Срок оценки: Baseline, month 3, month 6, month 9, month 12, month 18, month 24, month 30, month 36]
Критерии участия
Критерии включения
i. Diagnostic criteria for CNSV
- The presence of an acquired and otherwise unexplained neurologic deficit
- The presence of either classic angiographic or histopathologic features of angiitis in the CNS
- No evidence of systemic vasculitis or any condition that could cause the angiographic or pathologic features
ii. ≥18 years of age
Критерии исключения
i. Unwilling to sign informed consent.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 4 центра
- Mayo Clinic — Rochester
- Cleveland Clinic — Cleveland
- University of Pennsylvania — Philadelphia
- Vanderbilt University — Nashville
Канада · 2 центра
- St. Joseph's Healthcare — Hamilton
- University of Toronto/Sinai Health — Toronto
Идентификаторы
NCT: NCT05734404 · VCRC5509