BREATH RESEARCH NARROW VALIDATION FOR GASTROINTESTINAL CANCER DETECTION

Sponsor
Imperial College London
Study ID
NCT07714538
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

We 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

Key Dates

First listed
Jul 20, 2026
Start date
Jul 20, 2026
Status verified
Jul 2026
Primary completion
Feb 2, 2028
Completion
Aug 2, 2028

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

To validate and refine a series of breath tests to detect the following conditions: CRC, PDAC, OGC, OSCC, HCC and CCC [ Time Frame: 30 Months ]

Central Contacts

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