Breath TestHOPENCT06611293
HOspital Versus Primary Care Breath Test Environment (HOPE) Study
An observational study of Breath Test, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
Through the HOPE study, the intention would be to determine whether exhaled breath volatile organic compound (VOC) profiles in Primary care differ from Secondary care. The intention would also be to assess intra-subject variability of participants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breath Test
- What is being tested?
- Breath test
- How many people
- 59 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 5 Feb 2025to 20 Dec 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Volunteers will be recruited to provide breath samples in both Primary and Secondary Care environments.
Who may be able to join
- Participants will be:
- Aged ≥ 18 years old
- Willing and able to provide informed consent to take part in study.
Who cannot join
- Pregnant women will be excluded from this study. With the exception of pregnant women, there are no additional strict exclusion criteria as individuals will act as their own control.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Imperial College London
London, W12 0NN
Imperial College London
London
About this study
Through the HOPE study, the intention would be to determine whether exhaled breath volatile organic compound (VOC) profiles in Primary care differ from Secondary care. The intention would also be to assess intra-subject variability of participants. This would allow us to determine if the results of breath samples are reproducible regardless of whether they are performed in a Primary or Secondary care environment. This would support the clinical translation of breath research outcomes from studies performed in Secondary care, despite the breath test being intended for use in Primary care.
The chief investigator of the HOPE study is Professor George Hanna (Head of Department of Surgery and Cancer, and Professor of Surgical Sciences at Imperial College London).
Read the detailed description
A breath test is a non-invasive investigation. The use of a breath test as a triage tool - for cancer or other diseases - in symptomatic patients could identify high-risk patients who should be referred for investigations at an earlier stage. This would increase the proportion of appropriate referrals from Primary care and improve adherence to National Institute for Clinical Health and Excellence (NICE) guidance. If a General Practitioner (GP) is presented with a patient with symptoms that do not prompt referral under NICE guidelines, he/she would no longer need to watch-and-wait to see if their symptoms worsen, but could instead offer a breath test immediately. Breath samples would be collected and sent to a regional laboratory for analysis. A positive result would warrant immediate referral for further specialised investigations, whilst a negative test would permit the GP to reassure the patient and offer re-testing if symptoms persist.
The MAGIC (Methodological Approaches towards a GastroIntestinal Cancer test) study was performed to assess whether breath testing is feasible in Primary care. In this study, 1002 patients took part in the breath test in Primary care. Ninety-nine percent of patients found the breath test very easy or easy to perform, and it was demonstrated that breath testing is feasible in Primary care.
However, the potential for an individual's exhaled breath VOC profile to change when measured across Primary and Secondary care sites has not yet been investigated.
- Conditions
- Breath Test
- Being tested
- Breath test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath testDiagnostic test
Participants will perform breath testing in Primary care followed by Secondary care on Day 1. At each location, participants will be asked to perform three breath tests (15 minutes apart). The environmental air will also be sampled.
This entire process will be repeated in the reverse order (i.e. breath testing in Secondary care followed by Primary care on Day 2).
Participants will be asked to maintain a clear fluid diet for a minimum of six hours prior to breath collection on both Day 1 and Day 2 of sampling.
| Study group | Role | What they receive |
|---|---|---|
| Volunteers taking part in study | Not described Receives: Diagnostic Test: Breath test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The variation in exhaled breath VOC profile in the participants in Primary versus Secondary Care setting.
An exploratory analysis will be performed to identify and exclude contaminated samples. Linear mixed models will be fitted for each compound's measurements to estimate components of variation (between individuals, occasions and repeat samples), and confirm that there is no effect of ordering (hospital-GP vs GP-hospital). Repeatability of each day-location combination will be summarised as the intra-class correlation coefficient (ICC) and the coefficient of variation (CV).
The observed differences will be compared with the clinically acceptable limits for each VOC to identify the proportion of GP-hospital differences that fall within these limits. For each VOC, the ICC, CV and the limits of agreement with 95% confidence interval will be reported, along with how they compare with the clinically acceptable differences.
Measured: 2 years
Secondary outcomes (1)
The intra-subject variability in exhaled breath VOCs when breath is sampled 15 minutes apart on different days.
Please see \"Description\" for \"Primary Outcome Measure\".
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start5 Feb 2025
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breath TestStudies 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
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06611293
- Sponsor's protocol ID
- 24HH8812
- Acronym
- HOPE
- Status last verified
- Jul 2026
- First submitted
- 16 Sep 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HOspital Versus Primary Care Breath Test Environment (HOPE) Study
- ClinicalTrials.gov ID
- NCT06611293
- Acronym / sponsor ID
- HOPE / 24HH8812
- Conditions
- Breath Test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- 5 Feb 2025 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 24 Sep 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.
Through the HOPE study, the intention would be to determine whether exhaled breath volatile organic compound (VOC) profiles in Primary care differ from Secondary care. The intention would also be to assess intra-subject variability of participants. This would allow us to determine if the results of breath samples are reproducible regardless of whether they are performed in a Primary or Secondary care environment. This would support the clinical translation of breath research outcomes from studies performed in Secondary care, despite the breath test being intended for use in Primary care.
The chief investigator of the HOPE study is Professor George Hanna (Head of Department of Surgery and Cancer, and Professor of Surgical Sciences at Imperial College London).
Detailed description
A breath test is a non-invasive investigation. The use of a breath test as a triage tool - for cancer or other diseases - in symptomatic patients could identify high-risk patients who should be referred for investigations at an earlier stage. This would increase the proportion of appropriate referrals from Primary care and improve adherence to National Institute for Clinical Health and Excellence (NICE) guidance. If a General Practitioner (GP) is presented with a patient with symptoms that do not prompt referral under NICE guidelines, he/she would no longer need to watch-and-wait to see if their symptoms worsen, but could instead offer a breath test immediately. Breath samples would be collected and sent to a regional laboratory for analysis. A positive result would warrant immediate referral for further specialised investigations, whilst a negative test would permit the GP to reassure the patient and offer re-testing if symptoms persist.
The MAGIC (Methodological Approaches towards a GastroIntestinal Cancer test) study was performed to assess whether breath testing is feasible in Primary care. In this study, 1002 patients took part in the breath test in Primary care. Ninety-nine percent of patients found the breath test very easy or easy to perform, and it was demonstrated that breath testing is feasible in Primary care.
However, the potential for an individual's exhaled breath VOC profile to change when measured across Primary and Secondary care sites has not yet been investigated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Volunteers taking part in study | – | Diagnostic Test: Breath test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteers will be recruited to provide breath samples in both Primary and Secondary Care environments.
Key inclusion criteria (3 listed)
- Aged ≥ 18 years old
- Willing and able to provide informed consent to take part in study.
Key exclusion criteria (1 listed)
- Pregnant women will be excluded from this study. With the exception of pregnant women, there are no additional strict exclusion criteria as individuals will act as their own control.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath testParticipants will perform breath testing in Primary care followed by Secondary care on Day 1. At each location, participants will be asked to perform three breath tests (15 minutes apart). The environmental air will also be sampled. This entire process will be repeated in the reverse order (i.e. breath testing in Secondary care followed by Primary care on Day 2). Participants will be asked to maintain a clear fluid diet for a minimum of six hours prior to breath collection on both Day 1 and Day 2 of sampling. | Diagnostic test | Volunteers taking part in study |
Primary outcome
The variation in exhaled breath VOC profile in the participants in Primary versus Secondary Care setting.
Time frame: 2 years
An exploratory analysis will be performed to identify and exclude contaminated samples. Linear mixed models will be fitted for each compound's measurements to estimate components of variation (between individuals, occasions and repeat samples), and confirm that there is no effect of ordering (hospital-GP vs GP-hospital). Repeatability of each day-location combination will be summarised as the intra-class correlation coefficient (ICC) and the coefficient of variation (CV). The observed differences will be compared with the clinically acceptable limits for each VOC to identify the proportion of GP-hospital differences that fall within these limits. For each VOC, the ICC, CV and the limits of agreement with 95% confidence interval will be reported, along with how they compare with the clinically acceptable differences.
1 secondary outcome
The intra-subject variability in exhaled breath VOCs when breath is sampled 15 minutes apart on different days.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breath Test, run by Imperial College London at 2 sites 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The variation in exhaled breath VOC profile in the participants in Primary versus Secondary Care setting. (time frame: 2 years). 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 29 Jul 2026.