Идёт набор NCT06734000

Cohorte COSCINUS - Biocollection

— Наблюдательное Spinal Cord Injury

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: Spinal Cord Injury. Базовые параметры: от 16 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: Франция
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

Cohorte COSCINUS - Biocollection COhort in Spinal Cord Injury - Nantes Follow-Up Standardization

Обзор

COSCINUS is a standardized framework for evaluating temporal trends in SCI causes, SCI characteristics, and demographic patterns. It allows a precise estimation of medical complications' incidence, their evolution over time, as well risk factors influencing these complications, including management modalities. Moreover, COSCINUS provides a high-quality research platform, including clinical, epidemiological, biostatistical, and IT expertise, thereby promoting fundamental research in spinal cord injury and related autonomic dysfunctions. As a national epidemiological tool, COSCINUS offers unique analytical perspectives, promising significant contributions to the understanding and management of spinal cord injuries.

Подробное описание

The Neurological Physical and Rehabilitation Medicine (NPRM) Department at Nantes University Hospital, referral centre for SCI patients, has been working since 2015 on the creation of a comprehensive database. This database systematically collects a wide range of data, including socio-demographic, clinical, health status, activity and participation data for SCI patients.

Paired with this database is a longitudinal biocollection that preserves blood, urinary, and feces samples enabling analyses of the microbiome, biomarkers as metabolic, inflammatory, immune, and injury severity biomarkers.

The COSCINUS cohort and its biocollection, created through a multidisciplinary approach, are longitudinally structured. They entail meticulous and continuous recording of standardized data and specific sample collection across various phases of spinal cord injury management, from the acute phase through long-term follow-up.

Data and samples are collected prospectively at specific time points:

Acute phase, admission to PRM department, 6 months post-injury, discharge and during scheduled follow-up consultations (1 / 2 / 3 years post-injury…) with additional collection in case of complications

Первичные конечные точки

Dosage of urinary polyunsaturated fatty acid derivatives [Срок оценки: 5 years]
Analysis of fecal polyunsaturated fatty acid derivatives [Срок оценки: 5 years]
Analysis of the blood biomarker's evolution in individuals with a spinal cord injury from the injury [Срок оценки: 5 years]
Analysis of the biomarker's evolution in individuals with a spinal cord injury from the injury [Срок оценки: 5 years]

Критерии участия

Критерии включения

All individuals with spinal cord injury admitted to the neurological PRM department of the Nantes University Hospital at the initial phase of development of the paraplegia or tetraplegia could participate, regardless the clinical neurological status.