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Trial record 1 of 1 for:    NCT02283073
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Study for the Early Diagnosis of Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02283073
Recruitment Status : Active, not recruiting
First Posted : November 5, 2014
Last Update Posted : July 10, 2018
Sponsor:
Information provided by (Responsible Party):
Bio Shai Ltd.

Brief Summary:
The main objective of the study is to design and validate the blood based PDx gene expression and miRNA assay for the early diagnosis of Parkinson's disease patients. Differential diagnosis includes patients with Multiple System Atrophy, Progressive Supranuclear Palsy, Corticobasal Degeneration, Lewy Body Dementia, Essential Tremor and Normal Controls.

Condition or disease
Parkinson's Disease, Idiopathic

Detailed Description:

In this study, the PDx assay will be designed and validated in order to distinguish between Idiopathic Parkinson's disease (PD) to patients with similar symptoms and healthy controls. The differential diagnosis cohort includes patients diagnosed with Multiple System Atrophy (MSA), Progressive Supranuclear Palsy (PSP), Corticobasal Degeneration (CBD), Essential Tremor (ET) or Lewy Body Dementia (LBD) and Healthy Controls.

This is a prospective observational study. Blood samples and clinical data will be collected at the first and only study visit. The expression levels of 5 to 6 genes will be analyzed by blinding technicians concerning the diagnosis, demographic data and clinical data, which will be revealed after sending PDx gene expression values to the clinical sites. The gene expression levels will be compared between Parkinson's disease patients to the differential diagnosis cohort and healthy controls. Additional mRNA and miRNA markers will be explored. The primary aim of the study is to design and validate a clinical classifier that will aid the physician in the diagnosis of Parkinson's disease patients. The analysis will be performed in two stages: Stage 1) Exploration analysis and Stage 2) Validation. After one year of taking a blood sample, the study physician will contacted to confirm the patient's diagnosis.

Blood samples will be collected at specialized movement disorder clinics.

Medical history, clinical diagnostic features, family history in regard to Parkinson's disease, use of medication and routine imaging assessment (not mandatory) will be collected at the first and only patient visit.


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Study Type : Observational
Actual Enrollment : 410 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: PDx Biomarker Assay Study for the Diagnosis of Parkinson's Disease
Study Start Date : November 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Idiopathic Parkinson's disease
Patient with clinical diagnosis of Idiopathic Parkinson's Disease according to Queen Square Brain Bank Criteria up to one year prior to enrollment in study.
Differential Diagnosis Group
MSA, PSP, CBD, Lewy body dementia, Essential Tremor, and Healthy Controls



Primary Outcome Measures :
  1. The Diagnostic Accuracy of PDx mRNA Assay in Diagnosing Idiopathic Parkinson's Disease [ Time Frame: One year from enrollment ]
    Investigate the diagnostic accuracy of the PDx gene expression assay, comprised of 5-6 expressed genes (mRNA - RQ-PCR), to differentiate patients with Idiopathic Parkinson's disease from the Differential Diagnosis Group. Diagnostic Accuracy includes sensitivity, specificity, likelihood ratios and the area under the receiver operating characteristic (ROC) curve. Diagnostic Accuracy will be calculated by comparing the PDx assay results to the Gold Standard Diagnosis, which will be the Clinical diagnosis of the Patient one year after the first and only visit (day of blood collection). The physician investigator will be contacted if there was any change in the baseline diagnosis one year after blood collection according to routine clinical findings.


Secondary Outcome Measures :
  1. Diagnostic Accuracy of each one of the PDx assay's expressed genes for Differentiating Idiopathic Parkinson's Disease Patients from Atypical Parkinsonism Patients. [ Time Frame: One year from enrollment ]
    Investigate the diagnostic accuracy (sensitivity, specificity, likelihood ratios and AUC) of each one of the PDx assay expressed genes (RQ-PCR) to differentiate Idiopathic Parkinson's Disease Patients from Atypical Parkinsonism Patients.

  2. Diagnostic Accuracy of each one of the PDx assay's expressed genes for Differentiating Idiopathic Parkinson's Disease Patients from Essential Tremor Patients. [ Time Frame: One year from enrollment ]
    Investigate the diagnostic accuracy (sensitivity, specificity, likelihood ratios and AUC) of each one of the PDx assay expressed genes (RQ-PCR) to differentiate Idiopathic Parkinson's Disease Patients from Essential Tremor Patients.

  3. Diagnostic Accuracy of each one of the PDx assay's expressed genes for Differentiating Idiopathic Parkinson's Disease Patients from Healthy Controls. [ Time Frame: One year from enrollment ]
    Investigate the diagnostic accuracy (sensitivity, specificity, likelihood ratios and AUC) of each one of the PDx assay expressed genes (RQ-PCR) to differentiate Idiopathic Parkinson's Disease Patients from Healthy Controls.


Biospecimen Retention:   Samples Without DNA
The mRNA in blood samples will be transcribed to cDNA.


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Movement disorder clinics
Criteria

Inclusion Criteria:

  • Patient is able and willing to read the informed consent form
  • Patient with clinical diagnosis of Idiopathic Parkinson's Disease according to Queen Square Brain Bank Criteria up to one year prior to enrollment in study
  • Patient with diagnosis of MSA, PSP, CBD, Lewy Body Dementia, Essential Tremor or Healthy Control
  • Men and Women aged 40-80 years
  • Willing and able to comply with procurement of blood sample

Exclusion Criteria:

  • Any medical, psychiatric or other conditions which, in the opinion of the investigator, would preclude participation
  • Pregnancy

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): NCT02283073


Locations
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Israel
Rambam Health Care Campus
Haifa, Israel, 31096,
Rabin Medical Center
Petach Tikvah, Israel, 4941492
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 64239
Chaim Sheba Medical Center
Tel HaShomer, Israel, 52621
Assaf Harofeh Medical Center
Tsrifin, Israel, 70300
Italy
Pisa University Hospital
Pisa, Italy, 56126
Sponsors and Collaborators
Bio Shai Ltd.
Investigators
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Principal Investigator: Ofer Gonen, MD Assaf-Harofeh Medical Center

Publications:
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Responsible Party: Bio Shai Ltd.
ClinicalTrials.gov Identifier: NCT02283073     History of Changes
Other Study ID Numbers: PDx001
82/14 ( Other Identifier: Assaf HaRofeh )
TASMC -14-TG-0489-14-TLV-CTIL ( Other Identifier: Tel Aviv Sourasky Medical Center )
1735-14-SMC ( Other Identifier: Sheba Medical Center )
0463-14-RMB ( Other Identifier: Rambam Health Care Campus )
First Posted: November 5, 2014    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Keywords provided by Bio Shai Ltd.:
Diagnosis
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