Breath Research Narrow Validation for Gastrointestinal Cancer Detection

NCT07714538 | Not Yet Recruiting

• 1 other identifier: 200069
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 6

Brief Summary

The investigators of this study are developing a simple breath test to help detect gastrointestinal (gut) cancers earlier, including cancers of the oesophagus (food pipe), stomach, pancreas, liver and bowel. These cancers often cause non-specific symptoms that are similar to benign conditions, making early diagnosis difficult. Delays between the onset of symptoms and referral for a diagnostic test such as an endoscopy or a scan, can allow the cancer to progress. The breath test detects small molecules called volatile organic compounds (VOCs) that are released in exhaled breath. Some of these VOCs are strongly associated with these cancers and may help identify high-risk patients who require urgent investigation. In practice, patients who come to their GP with concerning symptoms will be offered the breath test. If the test is positive, patients can be referred promptly for a diagnostic test, while those with a negative result can be reassured and offered re-testing if symptoms persist. Earlier diagnosis could improve access to curative treatment while reducing unnecessary invasive investigations. Previous studies have identified a panel of VOCs that appear to distinguish patients with gastrointestinal cancers from those without cancer. This study aims to confirm these findings in a new group of participants to determine whether the same biomarkers can be reliably identified. Participants will provide a breath sample, usually before a hospital procedure they are already scheduled to undergo, and complete a short questionnaire about their medical history and medications. Some participants will also be asked to drink a nutritional supplement before providing a second breath sample. The results will help determine whether the breath test is reliable enough for further clinical evaluation

Conditions

Oesophageal Squamous Cell Carcinoma; Oesophageal Adenocarcinoma; Gastric Adenocarcinoma; Pancreatic Ductal Adenocarcinoma (PDAC); Cholangiocarcinoma; Hepatocellular Carcinoma (HCC); Colorectal Adenocarcinoma

Keywords

Early Detection; Volatile Organic Compunds; Oesophageal Cancer; Gastric Cancer; Colorectal Cancer; Liver Cancer; Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• To validate and refine a series of breath tests to detect the following conditions: CRC, PDAC, OGC, OSCC, HCC and CCC

  Estimation of sensitivity, specificity and numbers of false positives (with 95% confidence intervals) for breath tests to detect CRC, PDAC, OGC, OSCC, HCC and CCC.

  30 Months

Study Arms (5)

Oesophagogastric Arm

Cases will be patients with histology-confirmed, treatment naïve oesophageal (OAC) or gastric adenocarcinoma (GAC) and controls will be patients who have a normal upper GI tract or benign condition as diagnosed on the reference test (upper GI endoscopy). All eligible patients will be invited to participate. Participants will attend a one off research visit, after having fasted for 6 hours (water permitted) and sign a consent form. They will rinse their mouth with water, provide a baseline breath sample and consume an oral stimulant drink (a nutrient supplement). A further breath sample will be collected after 15 minutes, and an additional environment sample will also be collected. Participants will answer questions about their medical and drug history.

Oesophageal SCC Arm

Cases will be patients with histology-confirmed, treatment naive Oesophageal Squamous Cell Carcinoma (OSCC) and controls will be patients who have a normal upper GI tract or benign condition as diagnosed on the reference test (upper GI endoscopy). All eligible patients will be invited to participate. Participants will attend a one-off research visit, after having fasted for 6 hours (water permitted) and sign a consent form. They will rinse their mouth with water and provide a breath sample. An additional environment sample will also be collected. Participants will answer questions about their medical and drug history.

Pancreatic Arm

Cases will be patients with histology-confirmed, treatment naïve pancreatic ductal adenocarcinoma (PDAC) and controls will be patients with non-specific abdominal symptoms and a radiologically-normal pancreas as diagnosed on the reference test (ultrasound, MRI, CT, PET-CT and endoscopic ultrasound). All eligible patients will be invited to participate. Participants will attend a one-off research visit, after having fasted for 6 hours (water permitted) and sign a consent form. They will rinse their mouth with water and provide a breath sample. An additional environment sample will also be collected. Participants will answer questions about their medical and drug history.

Liver Arm

Cases will be patients with histology-confirmed, treatment naïve hepatocellular carcinoma (HCC) and cholangiocarcinoma (CCC) and controls will be patients with non-specific abdominal symptoms with a radiologically-normal liver as diagnosed on the reference test (ultrasound, MRI, CT and PET-CT). All eligible patients will be invited to participate. Participants will attend a one-off research visit, after having fasted for 6 hours (water permitted) and sign a consent form. They will rinse their mouth with water and provide a breath sample. An additional environment sample will also be collected. Participants will answer questions about their medical and drug history.

Colorectal Arm

Cases will be patients with histology-confirmed, treatment naïve colorectal adenocarcinoma (CRC) and controls will be patients with non-specific abdominal symptoms with a normal lower GI tract or benign condition of the colon as diagnosed on the reference test (colonoscopy). All eligible patients will be invited to participate. Participants will attend a one-off research visit, after having fasted for 6 hours (water permitted) and sign a consent form. They will rinse their mouth with water and provide a breath sample. An additional environment sample will also be collected. Participants will answer questions about their medical and drug history.

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

Adult Participants who meet the eligibility criteria and are being referred for further specialised investigations within the NHS.

You may qualify if:

• Adult participants ≥ 18 years old who meet at least one of the following criteria
• Colorectal arm:
• Cancer: Histologically-confirmed CRC\*
• Control: Non-specific abdominal symptoms with normal or benign colonoscopy findings
• Pancreatic arm:
• Cancer: Histologically-confirmed PDAC\*
• Control: Non-specific abdominal symptoms with a radiologically-normal pancreas
• Oesophagogastric arm:
• Cancer: Histologically-confirmed OGC\*
• Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings
• Oesophageal squamous arm:
• Cancer: Histologically-confirmed OSCC\*
• Control: Non-specific abdominal symptoms with normal or benign upper gastrointestinal endoscopy findings
• Liver arm:
• Cancer: Histologically- or radiologically-confirmed HCC or CCC\*

You may not qualify if:

• Patients who have already received chemotherapy, radiotherapy or surgery for their cancer
• History of another cancer (other than non-melanoma skin cancers) within three years
• Participants with co-morbidities preventing breath collection
• Unable or unwilling to provide informed consent
• (For Oesophagogastric arm only): Allergies to any of the constituents of the nutrient drink including glucose, glycerol, iron sulphate, Maltodextrin (Corn, Potato), Xanthan Gum, Potassium Chloride, tyrosine, phenylalanine, and glutamic acid
• (For Colorectal arm only): Participants receiving bowel prep in the previous 7 days

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator
• Maidstone & Tunbridge Wells NHS Trust: collaborator
• Royal Liverpool University Hospital: collaborator
• Royal Free London NHS Foundation Trust: collaborator
• NHS Greater Glasgow and Clyde: collaborator
• Chelsea and Westminster NHS Foundation Trust: collaborator
• St George's Healthcare NHS Trust: collaborator
• The Clatterbridge Cancer Centre NHS Foundation Trust: collaborator
• Hull University Teaching Hospitals NHS Trust: collaborator

Study Sites (6)

Maidstone and Tunbridge Wells NHS Trust

Maidstone, Kent, ME16 9QQ, United Kingdom

Location

Liverpool University Hospitals NHS Foundation Trust

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

NHS Greater Glasgow and Clyde

Glasgow, G12 0XH, United Kingdom

Location

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, L7 8YA, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, W12 0NN, United Kingdom

Location

Related Links

• Related Info

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma; Adenocarcinoma Of Esophagus; Cholangiocarcinoma; Carcinoma, Hepatocellular; Esophageal Neoplasms; Stomach Neoplasms; Colorectal Neoplasms; Liver Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Adenocarcinoma; Liver Diseases; Stomach Diseases; Intestinal Neoplasms; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• George Hanna, MBBS; PhD; FRSC

  Imperial College London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessie S McClymont, Medical Biosciences BSc

CONTACT

+44 7434937543; brave-study@imperial.ac.uk

Study Design

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

Study Record Dates

• First Submitted: July 15, 2026
• First Posted: July 20, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): February 2, 2028
• Study Completion (Estimated): August 2, 2028
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

GB (6)