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Clinical Trials/NCT06453226
NCT06453226
Recruiting
N/A

PArkinson's Non-Invasive Volatile ORganic Compound Analysis and Microbiome Assessment (PANORAMA) Study

Imperial College London1 site in 1 country120 target enrollmentJanuary 25, 2023

Overview

Phase
N/A
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Imperial College London
Enrollment
120
Locations
1
Primary Endpoint
Identification of biomarker and measurement of their levels for the development of a non-invasive breath test for Parkinson's diagnosis
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Parkinson's disease (PD) is the second most common neurodegenerative disorder. Currently, a diagnostic test for early PD does not exist.

The aim to address this problem by developing a non-invasive breath test to differentiate early PD from controls. Small molecules contained in breath, which offers precious information about disease presence, will be analysed. Data from the breath molecules and gut bacterial changes occurring in PD will be combined. These bacterial changes have been shown to arise years before the development of PD symptoms.

Thanks to earlier diagnosis, therapies could start in advance and improve clinical outcomes and quality of life.

Detailed Description

Detection of volatile organic compounds (VOCs) within exhaled breath and other biological matrices (such as urine, blood, saliva and skin) offers an attractive new strategy for non-invasive screening, diagnosis and monitoring of diseases. VOCs emitted by the body potentially reflect biochemical processes underlying physio-pathological states (Smith 2007). Non-invasive breath tests are well-accepted by patients, and for this reason they can offer the opportunity of large population screening and early diagnosis that can be crucial for several diseases (Belluomo 2021; Woodfield 2021). Despite breath testing has been proved effective to identify different disease states, among which cancer (Woodfield 2022) and infections (Kamal 2021), its application to neurodegenerative diseases remains still poorly explored. Parkinson's disease (PD) is one of the most common neurodegenerative disorders, with six million people affected worldwide and an incidence rate in rapid increase (Armstrong 2020). Currently, diagnosis of PD is based primarily on the presence of specific motor symptoms, such as bradykinesia, rigidity and rest tremor, which manifest when the progressive accumulation of Lewy body pathology and loss of melanised dopaminergic neurons in the substantia nigra pars compacta is already in a mid-late stage (Armstrong 2020). Misdiagnosis is common on clinical criteria alone, particularly at early presentation when symptoms overlap with other Parkinson-Plus syndromes and secondary Parkinsonism conditions (Rizzo 2016). Identification of novel biomarkers could lead to earlier and more accurate diagnoses and consequently remarkably improve patient management and quality of life. It is hypothesised that specific VOC signatures differentiate PD patients from healthy controls. The microbiome alterations found in PD could be at the origin of VOC decreased or increased production. The study recruitment will comprise patients with PD (50), healthy controls (mainly patient's partners or carers 50), and 20 de-novo not medicated PD patients. Different tyoes of samples will be collected (i) breath for volatile organic compound analysis (ii) stool for microbiome characterisation and (iii) blood for microvesicles extraction.

Registry
clinicaltrials.gov
Start Date
January 25, 2023
End Date
January 30, 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Identification of biomarker and measurement of their levels for the development of a non-invasive breath test for Parkinson's diagnosis

Time Frame: June 2025

The primary outcome is the identification of biomarkers and measurement of their levels in breath for the future development of a non-invasive breath test, able to diagnose Parkinson's disease. These levels will be measured using gas chromatography mass spectrometry. Differences will be identified in Parkinson's group vs de-novo and healthy controls and important compounds will be therefore identified.

Secondary Outcomes

  • Characterisation of microbiome in Parkinson patients, de novo and healthy controls(June 2025)

Study Sites (1)

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