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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03866603
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : March 14, 2022
Sponsor:
Information provided by (Responsible Party):
CENTOGENE GmbH 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 : June 30, 2022
Estimated Study Completion Date : September 30, 2022

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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


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment of 20,000 participants worldwide [ Time Frame: 37 months ]

Secondary Outcome Measures :
  1. Establishment of a LRRK2-positive biomarker in the LRRK2-positive cohort [ Time Frame: 40 months ]

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 to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clinically diagnosed Parkinson's Disease (PD) patients
Criteria
  • Informed consent is obtained from the par-ticipant
  • The participant is clinically diagnosed with Parkinson's disease
  • The participant is between 18 and 70 years old
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: ROPAD Clinical Project Manager +49 381 80 113 400 clinical.studies@centogene.com

Locations
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Sponsors and Collaborators
CENTOGENE GmbH Rostock
Investigators
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Principal Investigator: Peter Bauer, MD CENTOGENE GmbH
More Information
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Publications of Results:

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Responsible Party: CENTOGENE GmbH Rostock
ClinicalTrials.gov Identifier: NCT03866603    
Other Study ID Numbers: ROPAD 01-2019
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 14, 2022
Last Verified: October 2021
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 GmbH 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
Synucleinopathies
Neurodegenerative Diseases