Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06453226
Status:
RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-07
Brief Title:
Non-invasive Detection of Volatile Metabolites in Parkinsons Disease
Sponsor:
Imperial College London
Organization:
Imperial College London
Study Overview
Official Title:
PArkinsons Non-Invasive Volatile ORganic Compound Analysis and Microbiome Assessment PANORAMA Study
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PANORAMA
Brief Summary:
Parkinsons 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
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
Parkinsons 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 patients 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
Parkinsons 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 22NI0090 | OTHER | REC | None |