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BRAVENCT07714538

Breath Research Narrow Validation for Gastrointestinal Cancer Detection

StatusRecruiting
PhaseNot specified
Primary completion (estimated)

At risk: Primary completion moved 12 months later.

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Record History

All 4 versions: 4 with changes below. See every version on ClinicalTrials.gov ↗

  1. Notable Primary and study completion dates pushed to Feb 2, 2029
    • Eligibility criteria expanded, about 17 words
    • Collaborators: details revised at 2 of 9 entries
    • Study description expanded, about 5 words
  2. Notable Recruitment opened
    • Start date changed from estimate of Jul 20, 2026 to Jul 26, 2026
    • Site details revised at 6 of 6 sites
    v3
  3. Minor Study description expanded, about 5 wordsv2
  4. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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

Arms and interventions

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.

Sites

6 sites in 1 country