PAN Alimentary Cancer Exhaled Breath Analysis

NCT06764641 | Recruiting

• 1 other identifier: NIHR207551
• Study Type: observational
• Target: 8,000
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Each year in the United Kingdom there are over 44,000 deaths related to gastrointestinal (gut) cancers that include oesophageal (food pipe), stomach, pancreas, liver and bowel cancers. These cancers are difficult to detect as the symptoms are similar to non-cancer conditions. The delay in suspecting cancer and referral to a camera test (endoscopy) or scans can lead to the growth of cancer. Even with urgent referral only 4 out of every 100 patients are found to have cancer. If diagnosed early, the majority of people can survive gastrointestinal cancer. However, as the disease progresses, the number of people who survive falls significantly. Early diagnosis is therefore key. The proposed solution is a simple breath test for patients with relevant symptoms. Breath testing is quick, acceptable and can be offered directly by a GP. The breath samples are analysed for small molecules called volatile organic compounds. These molecules provide early indicators of gastrointestinal cancer, to identify those who would benefit most from investigations. Picking up gastrointestinal cancers earlier will increase the chances of curing the disease. Aims: breath molecules that are specific to gastrointestinal cancers have been previously identified. The aim is to confirm these molecules and examine the accuracy of the breath test. How to implement the test in primary care will also be studied. Design and Methods: Breath testing will be performed on at least 8,000 patients referred by GPs on suspected gastrointestinal cancer pathways. Patients will be followed up to determine whether they have gastrointestinal cancer or not. The breath test will take place in national NHS hospitals before patients undergo camera tests or scans. The breath test involves them breathing out into a bag allowing the breath to be collected into special tubes. The breath samples in the tubes will be analysed in the local laboratory. Which molecules in patients' breath samples correctly identify cancer will be confirmed. The key members will be engaged with to implement the breath test in primary care and NHS and assess the affordability of the breath test. Patient and public involvement and engagement (PPIE): A diverse PPIE group of 6 members affected by gastrointestinal cancer have identified clear benefits to patients and GPs and provided ways to improve patient recruitment. Work was with charities and appointed a patient representative to the local committee to support dissemination. The results will be disseminated through scientific papers and reports, conference presentations, public-facing areas, social media and cancer charity newsletters.

Conditions

Breath Test

Outcome Measures

Primary Outcomes (1)

• Discovery and validation of VOC biomarkers for multiple gastrointestinal cancers (oesophageal, gastric, liver, pancreatic and colorectal)

  GC-MS will be used to confirm the presence of gastrointestinal cancer-associated VOCs in order to develop the detection model.

  2.5 years

Study Arms (1)

Participants referred along upper and lower gastrointestinal suspected cancer pathways

Participants referred by GPs to secondary care for the reference test (i.e. upper/lower gastrointestinal endoscopy, CT/MRI/ultrasound ± histological/cytology). Participants will be followed up (within 3 months) to determine whether they had a diagnosis of gastrointestinal cancer (oesophageal, gastric, pancreatic, liver or colorectal) or a normal/benign diagnosis.

Diagnostic Test: Breath test

Interventions

Breath test DIAGNOSTIC_TEST

Participants must be fasted for a minimum of six hours prior to breath sample collection. Breath samples will be collected prior to the reference test for each participant (i.e. upper/lower gastrointestinal endoscopy, CT/MRI/ultrasound ± histological/cytology)

Participants referred along upper and lower gastrointestinal suspected cancer pathways

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients seen in a hospital (secondary or tertiary level care) setting

You may qualify if:

• Aged ≥ 18 years old.
• Participants with non-specific symptoms referred from primary care along upper and lower gastrointestinal cancer pathways for the reference test (upper/lower gastrointestinal endoscopy, CT/MRI/ultrasound ± histological/cytological confirmation).
• Willing and able to provide informed written consent to take part in study.

You may not qualify if:

• Previous oesophageal, gastric, liver, pancreatic or colonic resection
• History of another cancer within three years
• Co-morbidities preventing breath collection
• Pregnant participants
• Unable or unwilling to provide informed written consent.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial NHS Trust

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: January 2, 2025
• First Posted: January 8, 2025
• Study Start: March 5, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)