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Rostock International Parkinson's Disease Study (ROPAD) (ROPAD)

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ClinicalTrials.gov Identifier: NCT03866603
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : January 6, 2021
Sponsor:
Information provided by (Responsible Party):
Centogene AG Rostock

Study Description
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Brief Summary:
Rostock International Parkinson's Disease Study - An International, multicentre, epidemiological observational study aiming at identification of 1,500 LRRK2-positive patients, the identification of 1,500 non-LRRK2 PD patients and the establishment of a candidate biomarker in the LRRK2-positive cohort.

Condition or disease
Parkinson´s Disease

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Study Design
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rostock International Parkinson's Disease Study: an International, Multicenter, Epidemiological Observational Study
Actual Study Start Date : May 30, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

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Groups and Cohorts
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Group/Cohort
Parkinson´s disease individuals
The participants that are clinically diagnosed with Parkinson's disease
Family member of a participant with LRRK2 parkinsonism
The first and second degree family members of the ROPAD Study participants with LRRK2 parkinsonism
High risk population
Populations at high risk such as Ashkenazi Jewish and Arab Berber


Outcome Measures
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Primary Outcome Measures :
  1. To identify 1,500 LRRK2-positive participants [ Time Frame: 2 years ]
    The participants fulfilling the eligibility criteria will be enrolled into the Study and genetically tested for LRRK2 hotspot mutations and the whole GBA gene will be sequenced.


Secondary Outcome Measures :
  1. To identify 1,500 non-LRRK2 PD participants [ Time Frame: 2 years ]
    Participants with negative results for LRRK2 hotspots and GBA, clinically diagnosed for PD and are willing to participate in further genetic screening, 68 PD associated genes will be sequenced.


Other Outcome Measures:
  1. Establishment of candidate LRRK2-positive biomarkers in the LRRK2-positive cohort [ Time Frame: 2 years ]
    LRRK2-positive samples will be validated for the identification of potential biomarkers (based on MS/MS-Spectroscopy) and compared with a merged control sample in order to establish a LRRK2 specific biomarker.


Biospecimen Retention:   Samples With DNA
Blood sample applied on the Dry Blood Spot (DBS) Filtercard (Centocard®)

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's disease patients and LRRK2 carriers and high risk population
Criteria

Inclusion Criteria:

  • Informed consent is obtained from the participant.
  • The participant is equal to or older than 18 years old.
  • The participant is clinically diagnosed with Parkinson's disease
  • The participant is a family member of a participant with LRRK2 parkinsonism.
  • The participant is a member of a high risk population.

Exclusion Criteria:

  • Inability to provide informed consent.
  • The participant is younger than 18 years old.
  • The participant is not suffering from Parkinson's disease.
  • The participant is not a family member of a participant with LRRK2 parkinsonism.
  • The participant is not a member of a high risk population.
  • Previously enrolled in the study.
  • Participant in custody.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866603


Contacts
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Contact: Volha Skrahina, PhD +49 (0)38180113594 volha.skrahina@centogene.com
Contact: Hanaa Gaber, PhD +49 (0)38180113633 hanaa.gaber@centogene.com

Locations
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Sponsors and Collaborators
Centogene AG Rostock
Investigators
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Principal Investigator: Arndt Rolfs, Prof. Dr. CENTOGENE GmbH
More Information
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Publications of Results:

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Responsible Party: Centogene AG Rostock
ClinicalTrials.gov Identifier: NCT03866603    
Other Study ID Numbers: ROPAD 01-2019
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: January 6, 2021
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The plan will be defined at a later stages

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centogene AG Rostock:
Parkinson´s disease
Biomarker
LRRK2
GBA
PD Genetics
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases