LuxPARK: Earlier Diagnosis and Better Treatment Mission Related to the Cohort Programme
Study Details
Study Description
Brief Summary
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, we 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| PD patients Subjects with neurodegenerative disease or having degenerative parkinsonism (typical PD or atypical parkinsonism) |
Other: Observational study with sample and data collection
Observational study with sample and data collection
|
| Healthy controls Gender- and age-matched healthy controls |
Other: Observational study with sample and data collection
Observational study with sample and data collection
|
Outcome Measures
Primary Outcome Measures
- 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 [through study completion, an average of 8 years]
1.1. Samples will be aliquoted and stored according to the highest standards at the IBBL for future research.
- 2. Stratification of parkinsonism into subtypes and definition of individual progression trajectories of PD. [through study completion, an average of 8 years]
2.1. Identify PD patients' subgroups with a similar pattern of disease progression. datasets.
- Determine Parkinson's disease biomarker signatures [through study completion, an average of 8 years]
3.1. Identify new and early diagnostic biomarkers
- Develop a mechanistic understanding of the disease [through study completion, an average of 8 years]
4.1. Understand the mechanisms of PD pathogenesis.
Secondary Outcome Measures
- Inform future studies testing new therapies for Parkinson's disease [through study completion, an average of 8 years]
1.1. Enable future studies, such as clinical trials, by sharing the findings of mechanisms of PD pathogenesis and identifying new therapeutic targets.
- Harmonization of data with international Parkinson's disease cohort studies [through study completion, an average of 8 years]
2.1. Data collected in this study will be harmonized with the international PD research community through an open-source digital platform.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Subjects with neurodegenerative disease or having Parkinson's disease (typical PD or atypical parkinsonism)
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Subjects of all genders with a full capacity of consent
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Subjects with a limited consent capacity if the legal guardian/authorised representative is in agreement
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Subjects of at least 18 years of age at the time of inclusion
Exclusion Criteria:
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Refusal to sign the informed consent
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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
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Active cancer
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Pregnant women
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Underage subjects of less than 18 years of age
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Refusal to comply with mandatory sample collection
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For invasive procedures, i.e., lumbar puncture and skin biopsy: relevant blood clotting impairment, e.g., anamnestic evidence of frequent or prolonged bleedings.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre Hospitalier de Luxembourg (CHL), "Parkinson's Research Clinic" | Luxembourg | Luxembourg | 1210 | |
| 2 | Clinical and Epidemiological Investigation Center (CIEC) | Luxembourg | Luxembourg | 1445 |
Sponsors and Collaborators
- Luxembourg Institute of Health
- Luxembourg Centre for Systems Biomedicine (LCSB), University of Luxembourg - Co-sponsor
- Laboratoire National de Santé (LNS)
- Centre Hospitalier du Luxembourg
Investigators
- Principal Investigator: Rejko Rejko, Dr, Luxembourg Institute of Health
Study Documents (Full-Text)
None provided.More Information
Additional Information:
- Website accessible by participants and researcher giving information on the study an related activities
- Publication on the initial cohort
Publications
None provided.- CNER 140174_ND