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Идёт набор NCT05266872

Earlier Diagnosis and Better Treatment Mission Related to the Cohort Programme

— Наблюдательное Parkinson 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: Observational study with sample and data collection.
Кому может быть актуально
Состояния в реестре: Parkinson 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
Luxembourg
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

Biomaterial Collection for Neurodegenerative Disease Research (ND Collection)

Обзор

The Luxembourg Parkinson's Study is an ongoing longitudinal nationwide monocentric observational study. It collects extensive clinical, molecular, genetic, and digital device-based longitudinal data, as well as foreseen post-mortem diagnostic validation (Hipp et al., 2018). The cohort consists of more than 1,600 participants from Luxembourg and the Greater Region, comprising patients with typical PD or atypical parkinsonism - irrespective of disease stage, age, cognitive status, comorbidities, or linguistic background - followed-up annually and age- and sex-matched healthy control subjects followed-up every 4 years. To provide a large, longitudinally followed, and deeply phenotyped set of patients and controls for clinical and fundamental research on PD, the investigators have implemented an open-source digital platform that has been partly harmonized with other international PD cohort studies. This effort is flanked by comprehensive biosampling efforts assuring high quality and sustained availability of body liquids and tissue biopsies (including blood, urine, stool, saliva, hair, skin biopsy and cerebrospinal fluid). All data and samples are stored, curated, and integrated into state-of-the-art data and biobank facilities.

Вмешательства

  • Другое Observational study with sample and data collection
    Observational study with sample and data collection

Первичные конечные точки

  • 1. Establish an open collection of a large set of diverse longitudinal bio-samples and data for research in 800 PD patients and 800 controls [Срок оценки: through study completion, an average of 8 years]
  • 2. Stratification of parkinsonism into subtypes and definition of individual progression trajectories of PD. [Срок оценки: through study completion, an average of 8 years]
  • Determine Parkinson's disease biomarker signatures [Срок оценки: through study completion, an average of 8 years]
  • Develop a mechanistic understanding of the disease [Срок оценки: through study completion, an average of 8 years]
Вторичные конечные точки (2)
  • Inform future studies testing new therapies for Parkinson's disease [Срок оценки: through study completion, an average of 8 years]
  • Harmonization of data with international Parkinson's disease cohort studies [Срок оценки: through study completion, an average of 8 years]

Критерии участия

Критерии включения

  • Subjects with neurodegenerative disease or having Parkinson's disease (typical PD or atypical parkinsonism)
  • Subjects of all genders with a full capacity of consent
  • Subjects with a limited consent capacity if the legal guardian/authorised representative is in agreement
  • Subjects of at least 18 years of age at the time of inclusion

Критерии исключения

  • Refusal to sign the informed consent
  • Limited capacity of consent on the part of the donor, if there is no legally determined guardian/authorised representative, or the latter is not present or does not agree with the inclusion
  • Active cancer
  • Pregnant women
  • Underage subjects of less than 18 years of age
  • Refusal to comply with mandatory sample collection
  • For invasive procedures, i.e., lumbar puncture and skin biopsy: relevant blood clotting impairment, e.g., anamnestic evidence of frequent or prolonged bleedings.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Luxembourg · 2 центра
  • Centre Hospitalier de Luxembourg (CHL), "Parkinson's Research Clinic" — Luxembourg
  • Clinical and Epidemiological Investigation Center (CIEC) — Luxembourg

Публикации

  • Pavelka L, Rawal R, Ghosh S, Pauly C, Pauly L, Hanff AM, Kolber PL, Jonsdottir SR, Mcintyre D, Azaiz K, Thiry E, Vilasboas L, Soboleva E, Giraitis M, Tsurkalenko O, Sapienza S, Diederich N, Klucken J, Glaab E, Aguayo GA, Jubal ER, Perquin M, Vaillant M, May P, Gantenbein M, Satagopam VP, Kruger R; NCER-PD Consortium. Luxembourg Parkinson's study -comprehensive baseline analysis of Parkinson's dise PMID 38174101

Идентификаторы

NCT: NCT05266872 · CNER 140174_ND

Первоисточники (государственные реестры)

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