Parkinson DiseasePANORAMANCT06453226
Non-invasive Detection of Volatile Metabolites in Parkinson's Disease
An observational study of Parkinson Disease, run by Imperial College London at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 25 Jan 2023to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The population for this study will be divided in three groups: (i) Parkinson patients (ii) healthy controls (iii) de-novo patients.
Who may be able to join
- (i) Patients undergoing neurological examination for confirmed or suspected Parkinson's disease
- (ii) Patients aged ≥18 years and below 90 years of age;
- (iii) Patients off antibiotic or probiotic therapies for at least the last 4 weeks;
- (iv) Patients without formal diagnosis of dysbiotic conditions;
- (v) Patients with capacity.
- (i) healthy volunteers that may be or not partner or carer of a Parkinson's patient;
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- (ii) Subject aged ≥18 years and below 90 years of age;
- (iii) Patients off antibiotic or probiotic therapies for at least the last 4 weeks;
- (iv) Patients without formal diagnosis of dysbiotic conditions;
- (iiv) Subject with capacity.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Charing Cross Hospital, Imperial College London
London, W12 0NN
Ilaria Belluomo, Dr
020 7589 5111, i.belluomo@imperial.ac.uk
About this study
Official title: PArkinson's Non-Invasive Volatile ORganic Compound Analysis and Microbiome Assessment (PANORAMA) Study
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.
Read the 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.
- Conditions
- Parkinson Disease
- Keywords
- volatile organic compounds
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's group | Patients with confirmed Parkinson's disease undergoing neurological examination | |
| Healthy Controls | Patients will be asked to nominate a partner/carer that can be enrolled in the control group. Healthy controls will also be recruited using web-based adverts mainly via the Imperial Clinical Research Facility and Parkinson's disease charities. | |
| De-Novo | Patients undergoing neurological examination for suspected Parkinson's disease due to presence of symptoms |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of biomarker and measurement of their levels for the development of a non-invasive breath test for Parkinson's diagnosis
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.
Measured: June 2025
Secondary outcomes (1)
Characterisation of microbiome in Parkinson patients, de novo and healthy controls
Microbiome will be characterised in stool samples from the three study groups to identify differences due to Parkinson's. The bacteria type will be then linked to the VOC found in breath, to define if the VOC found in breath to differentiate Parkinson's patients from de novo and controls have a microbial origin.
Measured: June 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start25 Jan 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06453226
- Sponsor's protocol ID
- 311577
- Other IDs
- 22/NI/0090
- Acronym
- PANORAMA
- Status last verified
- Jun 2024
- First submitted
- 7 Jun 2024
- Last updated
- 13 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PArkinson's Non-Invasive Volatile ORganic Compound Analysis and Microbiome Assessment (PANORAMA) Study
- ClinicalTrials.gov ID
- NCT06453226
- Acronym / sponsor ID
- PANORAMA / 311577
- Conditions
- Parkinson Disease
- Keywords
- volatile organic compounds
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust
- Study start
- 25 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Parkinson's group | – | –Patients with confirmed Parkinson's disease undergoing neurological examination |
| Healthy Controls | – | –Patients will be asked to nominate a partner/carer that can be enrolled in the control group. Healthy controls will also be recruited using web-based adverts mainly via the Imperial Clinical Research Facility and Parkinson's disease charities. |
| De-Novo | – | –Patients undergoing neurological examination for suspected Parkinson's disease due to presence of symptoms |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The population for this study will be divided in three groups: (i) Parkinson patients (ii) healthy controls (iii) de-novo patients.
Key inclusion criteria (10 listed)
- (i) Patients undergoing neurological examination for confirmed or suspected Parkinson's disease
- (ii) Patients aged ≥18 years and below 90 years of age;
- (iii) Patients off antibiotic or probiotic therapies for at least the last 4 weeks;
- (iv) Patients without formal diagnosis of dysbiotic conditions;
- (v) Patients with capacity.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Characterisation of microbiome in Parkinson patients, de novo and healthy controls
Time frame: June 2025
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Imperial College London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilaria Belluomo, Dr (020 7589 5111, i.belluomo@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2024.