NCT03364894Fut, nem toboroz
The Personalized Parkinson Project (PPP)
The Personalized Parkinson Project (De Parkinson Op Maat Studie)
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. márc. 24.
Rövid összefoglaló (regiszter, angolul)
Background Our understanding of PD has stagnated, partly due to the limited patient diversity and brief followup captured in most study cohorts. Additionally, potentially valuable biomarkers derived from different types of measurements are rarely analyzed in an integrated fashion. Objective This study aims to create a longitudinal dataset of clinical, molecular, imaging, and continuous wearable sensor-based data from a representative Parkinson's disease (PD) cohort. Data will be made available to researchers worldwide to accelerate the discovery of novel etiological insights, development of new therapeutic approaches, and personalized disease management. For this purpose, an extensible norm for sharing research data will be developed, meeting the latest data privacy and security standards. Methods Supported by a multinational, public-private partnership, a prospective cohort study was designed to include 650 representative PD patients (disease duration \<5 years). Comprehensive follow-up for at least 2 years includes: (1) annual assessment at the study center for acquisition of detailed clinimetric data, magnetic resonance imaging, and biospecimens (plasma, serum, cerebrospinal fluid (CSF), stool) and (2) collection of data from the home environment, using self-assessments and an advanced wrist-worn wearable device to continuously measure biological and environmental signals. Collection, storage, and sharing of these research data will be facilitated by a new method to protect privacy and enhance security using polymorphic encryption and pseudonymization (PEP), a methodology that combines advanced encryption with distributed pseudonymization and data access management. Conclusion This study is unique, as it includes a cohort of unbiased subjects with recently diagnosed PD, creating an unprecedented dataset that combines longitudinally collected clinical, molecular, imaging, and data from wearable sensors using state of the art technology. The single-center study design minimizes measurement variability. Finally, the innovative methodology for data privacy and protection might serve as a new international standard for sharing research data.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 520 (tényleges)
- Első benyújtás
- 2017. nov. 23.
- Kezdés
- 2017. okt. 1.
- Elsődleges befejezés
- 2023. febr. 15.
- Fő szponzor
- Radboud University Medical Center
- Betegségek
- Parkinson-kór
- NCT-szám
- NCT03364894
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Bevont résztvevők: 520
- 2017. okt. 1. és az elsődleges befejezés (2023. febr. 15.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Contraindicated for MRI, e.g. claustrophobia, presence of an active implant, pacemaker, insulin pump, neurostimulator, ossicle prosthesis, and/or other medical device or other non-removable metal part incompatible with MRI.
- For lumbar puncture:
- Allergy to local anesthetic agents
- Medical history of compression of spinal cord, current local skin infection at the site of the lumbar puncture, developmental abnormalities in lower spine, blood coagulopathy, anticoagulant medication (Acenocoumarol, Warfarin, Dabigatran).
- Clinical (or previous MRI) evidence of structural cerebral abnormalities that are not compatible with the performance of a lumbar puncture such as malignancies, abscess, or obstructive hydrocephalus.
Más betegség
- Subject is allergic to nickel.
Egyéb
- Subject is pregnant or breastfeeding.
- Subject has co-morbidities that would hamper interpretation of parkinsonian disability, such as coincident musculoskeletal abnormalities, in the opinion of the Investigator.
Kiket keres a vizsgálat
- Subject has Parkinson's disease of ≤5 years duration, defined as time since diagnosis made by a neurologist.
- Subject is an adult, at least 18 years of age.
- Subject can read and understand Dutch.
- Subject has completed the Informed Consent form, as approved by the Ethics Committee.
- Subject is willing, competent, and able to comply with all aspects of the protocol, including follow-up schedule and biospecimen collection.
- Subject is not a current employee or family member of employees of the institutions involved in the study.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Radboud University Medical Center Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Nijmegen | Hollandia | Ismeretlen állapot |
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