HOspital Versus Primary Care Breath Test Environment (HOPE) Study

NCT06611293 | Recruiting

• 1 other identifier: 24HH8812
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 2

Brief 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. 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).

Conditions

Breath Test

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (1)

• The intra-subject variability in exhaled breath VOCs when breath is sampled 15 minutes apart on different days.

  2 years

Study Arms (1)

Volunteers taking part in study

Diagnostic Test: Breath test

Interventions

Breath test DIAGNOSTIC_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.

Volunteers taking part in study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Volunteers will be recruited to provide breath samples in both Primary and Secondary Care environments.

You may qualify if:

• Participants will be:
• Aged ≥ 18 years old
• Willing and able to provide informed consent to take part in study.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (2)

Imperial College London

London, W12 0NN, United Kingdom

NOT YET RECRUITING

Imperial College London

London, United Kingdom

RECRUITING

MeSH Terms

Interventions

Breath Tests

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Michael Fadel, BSc MBBS MRCS

CONTACT

+44 (0)20 7594 3396; m.fadel@imperial.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 24, 2024
• Study Start: February 5, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 1, 2025

Record last verified: 2025-04

Locations

GB (2)