Clinical trial · Observational
Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Oesophageal Squamous Cell Carcinoma (OSCC) is a cancer of the food pipe that affects around 2000 patients in the UK every year. It is often detected at an advanced stage, resulting in poor survival (5-year survival less than 20%). Early detection can improve survival (5-year survival \>70%). Therefore, early detection is vital to improving survival. There are no national screening guidelines, and an endoscopy (A camera test to look at the food pipe) is the only available test to detect OSCC. Early detection of OSCC is challenging for many reasons. Firstly, early disease symptoms are non-specific, which patients often overlook. Secondly, 'Alarm' symptoms such as weight loss, difficulty swallowing or vomiting blood are signs of advanced stage. Lastly, endoscopy is an invasive test with associated risks and significant discomfort. The investigators propose to develop a breath test for patients with non-specific symptoms. Breath testing has the ideal characteristics for a triage test because it is non-invasive, simple to perform, cost-effective and highly acceptable to patients. The test is based on identifying volatile organic compounds (VOCs, small molecules) that are produced by the cancer and released in breath. The breath test will be offered by General Practitioners (GPs) to patients with non-specific symptoms. Those who test positive will be referred for an urgent camera test, and those who test negative can be reassured.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oesophageal Cancer | — | UNRESOLVED | — |
| Oesophageal Squamous Cell Carcinoma | Esophageal Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Exhaled breath sampling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- OSCC group
- description
- Patients with histopathology confirmed, treatment naive OSCC
- interventionNames
- Other: Exhaled breath sampling
- label
- Non-cancer controls
- description
- Patients who are undergoing an endoscopy for non-specific upper gastrointestinal (GI) symptoms and are shown to have either: 1. A healthy upper GI tract 2. Benign upper gastrointestinal disease
- interventionNames
- Other: Exhaled breath sampling
Primary outcomes (1)
- measure
- To develop a breath test for detection of OSCC
- timeFrame
- 36 months
- description
- The investigators hypothesise that breath VOCs in OSCC are unique and different to those in non-cancer patients. Replicate breath samples will be analysed by two independent assays using different Thermal Desorption - Gas Chromatography - Time of Flight Mass Spectrometry (TD-GC-TOF-MS) instruments. One assay will use a mid-polar, and the other a polar column stationary phase for optimal determination of VOC chemical classes. The samples will then be recollected and analysed by two-dimensional (2D) TD-GC-TOF-MS for robust VOC identification. Confirming the identity of the top VOCs driving the model will provide chemical validation. Data obtained will be used to refine the model using molecular network analysis. Statistical methods will estimate the probability of OSCC as a function of measured VOCs. Calibrations and method validation will be used to assess and correct for discrimination.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: Participants with all the following characteristics will be eligible for inclusion in the study: 1. Cancer cohort (n=259): Patients with treatment naïve, histopathology confirmed OSCC. 2. Control cohort (n=259): Patients who have undergone or are undergoing an endoscopy (OGD) as part of their investigation for upper GI symptoms and are found to have either: * A normal upper gastrointestinal tract * Benign upper gastrointestinal disease Exclusion Criteria: Participants with the following characteristics will not be eligible for inclusion in the study: 1. Received some form of treatment (chemotherapy, radiotherapy, immunotherapy, endoscopic resection, or surgery) for OSCC 2. History of another cancer in the last five years 3. Non-squamous cell oesophageal cancer 4. Barrett's oesophagus (with or without dysplasia) 5. Previous oesophageal or gastric resection 6. Unable to provide written consent or lack capacity. 7. Pregnant women
References
Publications (0)
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