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miRNAs Profiling in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT03466723
Recruitment Status : Not yet recruiting
First Posted : March 15, 2018
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Daniela Ruggiero, Neuromed IRCCS

Tracking Information
First Submitted Date March 9, 2018
First Posted Date March 15, 2018
Last Update Posted Date March 19, 2018
Estimated Study Start Date June 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 16, 2018)
Identification of novel circulating miRNAs as biomarkers for Parkinson's disease [ Time Frame: 3 years ]
The study expects to discover novel circulating miRNAs as biomarkers for Parkinson's disease. As the deep phenotype characterization of the study sample, the project expects to identify new associations of identified miRNAs with disease-related parameters and define the role of miRNAs in the physiological pathways in which those parameters are involved and in the etiology of PD. Also, the understanding of the genetics of the disease will open avenues for novel therapeutic strategies
Original Primary Outcome Measures
 (submitted: March 9, 2018)
Identification of novel circulating miRNAs as biomarkers for Parkinson's disease [ Time Frame: 3 years ]
We expect to discover novel circulating miRNAs as biomarkers for Parkinson's disease. As the deep phenotype characterization of the study sample, we also expect to identify new associations of identified miRNAs with disease-related parameters and define the role of miRNAs in the physiological pathways in which those parameters are involved and in the etiology of PD. Also, the understanding of the genetics of the disease will open avenues for novel therapeutic strategies
Change History Complete list of historical versions of study NCT03466723 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title miRNAs Profiling in Parkinson's Disease
Official Title Novel and Minimal Invasive Biomarkers for Parkinson's Disease: Profiling of Serum Circulating miRNAs and Patho-physiological Implications
Brief Summary microRNAs (miRNAs) regulate fundamental cell processes. Dysregulation of miRNA expression and function is reported in various diseases including cancer, metabolic disorders as well as neurological disorders. Circulating miRNAs have been proposed to mirror physiological and pathological conditions suggesting their use as biomarkers for various diseases. The study will focus on a case-control study cohort (N=1000) of subjects recruited at the IRCCS Neuromed for which a deep clinical characterization and genome-wide sequencing data are available. This study will enable to identify novel circulating biomarkers for Parkinson's disease (PD). Further, the project will give new insights on the involvement of miRNAs in the etiology of PD and in the understanding of the genetics of the disease thus opening avenues for novel therapeutic strategies.
Detailed Description

Hypothesis and Significance:

The project intends to identify novel biomarkers for PD and clinical parameters related to the PD etiology. To do that circulating miRNA profiling through a next-generation sequencing will be performed using a single sample approach in the case-control study cohort and identified miRNAs will be validated by qRT-PCR and functional analyses. In addition, the project will contribute expanding the knowledge of the genetic architecture of PD taking advantage of genetic characterization of the study sample. miRNA genes and target genes will be used to prioritize genetic variants to be tested for association with PD to detect novel genes and functional variants that confer disease risk.

Specific Aim 1:

Profile of circulating miRNAs in the serum of PD patients and controls by next-generation sequencing in individual samples. Correlation between identified miRNAs and PD-related parameters and validation in independent cohorts

Specific Aim 2:

Bioinformatics prediction of target genes and miRNA functional validation

Specific Aim 3:

Identification of genes/genetic variants in miRNA pathways predisposing to PD

Expected outcomes:

The study will allow to discover novel circulating miRNAs as biomarkers for Parkinson's disease. As the deep phenotype characterization of the study sample, the project expects to find new associations of identified miRNAs with disease-related parameters and define the role of miRNAs in the physiological pathways in which those parameters are involved and in the etiology of PD. Also, the understanding of the genetics of the disease will open avenues for novel therapeutic strategies.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
DNA, RNA, Serum
Sampling Method Probability Sample
Study Population Collection of 1000 case-control study samples with a large phenotype and genotype characterization. The study includes 500 PD patients and 500 age/gender-matched controls. All PD patients have been diagnosed at the IRCCS Neuromed and followed-up (at least for 5 years) for disease progression. Data collected from patients and unrelated controls include: socio-demographic status, life style, anamnesis and family history, exposure to toxic chemical and/or environmental agents. Patients have been studied with a protocol comprising neurological examination (Stadio di Hoehn and Yahr, MDS-UPDRS part III, MOCA test) and evaluation of no motor symptoms. Information about drugs therapy have been also collected.
Condition Parkinson Disease
Intervention Genetic: biomarker identification in Parkinson disease
circulating miRNAs profiling by NGS analysis functional miRNA characterization association of miRNA levels with genetic variants
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: March 9, 2018)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 2021
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria for cases:

  • Presence of at least two out the following cardinal signs: resting tremor, cogwheel rigidity, bradykinesia, asymmetrical onset of symptoms and symptomatic response to L-dopa (levodopa)

Exclusion Criteria for cases:

  • Previous thalamotomy on the implanted sided, significant brain atrophy or structural damage seen on CT or MRI, marked cognitive dysfunction, active psychiatric symptoms, or concurrent neurological or other uncontrolled medical disorders.

Exclusion Criteria for controls:

Personal or family history for neurodegenerative diseases

Sex/Gender
Sexes Eligible for Study: All
Ages 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Daniela Ruggiero, Ph. D. +39 081 6132358 daniela.ruggiero@igb.cnr.it
Contact: Mafalda G Reccia, Ph.D. +39 0865 915249 mafaldareccia@yahoo.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03466723
Other Study ID Numbers DRPAR01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Daniela Ruggiero, Neuromed IRCCS
Study Sponsor Neuromed IRCCS
Collaborators Not Provided
Investigators
Principal Investigator: Daniela Ruggiero, Ph.D. Neuromed IRCCS
PRS Account Neuromed IRCCS
Verification Date March 2018