Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
410 participants
OBSERVATIONAL
2014-11-30
2019-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Differential Diagnosis Group
MSA, PSP, CBD, Lewy body dementia, Essential Tremor, and Healthy Controls
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Pregnancy
40 Years
80 Years
ALL
Yes
Sponsors
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Bio Shai Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Ofer Gonen, MD
Role: PRINCIPAL_INVESTIGATOR
Assaf-Harofeh Medical Center
Locations
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Rambam Health Care Campus
Haifa, , Israel
Rabin Medical Center
Petach Tikvah, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Assaf Harofeh Medical Center
Ẕerifin, , Israel
Pisa University Hospital
Pisa, , Italy
Countries
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References
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Berardelli A, Wenning GK, Antonini A, Berg D, Bloem BR, Bonifati V, Brooks D, Burn DJ, Colosimo C, Fanciulli A, Ferreira J, Gasser T, Grandas F, Kanovsky P, Kostic V, Kulisevsky J, Oertel W, Poewe W, Reese JP, Relja M, Ruzicka E, Schrag A, Seppi K, Taba P, Vidailhet M. EFNS/MDS-ES/ENS [corrected] recommendations for the diagnosis of Parkinson's disease. Eur J Neurol. 2013 Jan;20(1):16-34. doi: 10.1111/ene.12022.
Ma YM, Zhao L. Mechanism and Therapeutic Prospect of miRNAs in Neurodegenerative Diseases. Behav Neurol. 2023 Nov 23;2023:8537296. doi: 10.1155/2023/8537296. eCollection 2023.
Other Identifiers
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82/14
Identifier Type: OTHER
Identifier Source: secondary_id
TASMC -14-TG-0489-14-TLV-CTIL
Identifier Type: OTHER
Identifier Source: secondary_id
1735-14-SMC
Identifier Type: OTHER
Identifier Source: secondary_id
0463-14-RMB
Identifier Type: OTHER
Identifier Source: secondary_id
PDx001
Identifier Type: -
Identifier Source: org_study_id
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