Temporal Variation in Exhaled Volatile Organic Compounds in Esophageal Cancer Patients
- Conditions
- Esophageal Cancer
- Interventions
- Other: Exhaled VOC breath test
- Registration Number
- NCT06453993
- Lead Sponsor
- Benaroya Research Institute
- Brief Summary
The purpose of this study is to investigate whether exhaled breath can be used to detect and monitor esophageal cancer.
- Detailed Description
Esophageal cancer ("EG cancer") affects over half a millions people worldwide every year. Early esophageal cancer typically has non-specific symptoms that are often mistaken for benign (non-cancer) conditions. As a result, patients are often referred for further investigations only when they have more prominent symptoms that are typically associated with advanced incurable disease. As a consequence, 7 out of 10 new cases of EG cancer diagnosed are considered to be at an advanced stage, with less than 1 in 3 patients eligible for potentially curative therapy. Better ways of diagnosing esophageal cancer earlier are therefore needed. An ideal test for esophageal cancer would be non-invasive, simple to administer in the community, and cost effective.
The investigators' approach to this clinical challenge is to establish a non-invasive test for the detection of esophageal cancer that is based upon the unique signature of small molecules within exhaled breath. In this study that is being conducted in collaboration with researchers in the United Kingdom (UK), the investigators would like to measure the levels of these small molecules within the breath of patients with esophageal cancer at different times during their treatment: (i) at diagnosis; (ii) after chemoradiotherapy, and; (iii) after surgery. By studying how the small molecules contained within the breath change as a result of esophageal cancer and its treatment, the investigators hope to learn new information that can help develop a new test for this disease.
The investigators will also measure the small molecules within saliva and urine samples collected at the same time as breath in order to study if there are any important differences between these three samples. The investigators will also attempt to measure different bacteria
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 46
- Aged 18-90 years
- Newly-diagnosed, treatment naïve patients with esophageal and/or gastroesophageal junctional cancer
- Planning to undergo curative treatment, including neoadjuvant chemoradiotherapy and surgical resection
- Pregnant females
- Without malignant esophageal disease
- Malignancy at a secondary site other than the esophagus
- Undergoing palliative treatment for esophageal cancer
- Not receiving neoadjuvant chemoradiotherapy and surgical resection for esophageal cancer
- Inability or unwillingness to provide written informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Investigate whether exhaled breath can be used to detect and monitor esophageal cancer. Exhaled VOC breath test The procedures will include collecting participant's personal information and samples of participant's exhaled breath, urine, and saliva.
- Primary Outcome Measures
Name Time Method Exhaled breath and urinary VOC concentrations as biomarkers of esophageal cancer Before commencing treatment for esophageal cancer The composition and concentration of volitile organic compounds (VOC) in exhaled breath and urinary samples will be assessed to establish a VOC signature of esophogeal cancer
- Secondary Outcome Measures
Name Time Method Changes in VOC concentrations that occur in response to therapeutic intervention (i) Before commencing treatment for esophageal cancer, (ii) About 4 - 6 weeks after neoadjuvant therapy, (iii) About 3 - 5 days after surgical resection (but before hospital discharge), (iv) At routine follow up (6 - 12 months after surgery) VOC concentrations in exhaled breath and urinary samples will be assessed longitudinally to assess how VOC concentrations change in response to therapeutic intervention
Linkage of longitudinal VOC data to predominant upper gastrointestinal bacterial species (i) Before commencing treatment for esophageal cancer, (ii) About 4 - 6 weeks after neoadjuvant therapy, (iii) About 3 - 5 days after surgical resection (but before hospital discharge), (iv) At routine follow up (6 - 12 months after surgery) Bacterial RNA will be extracted from saliva samples to identify bacterial composition. Bacterial composition will then be correlated with breath and urinary VOC levels
Patient acceptability of breath test Before commencing treatment for esophogeal cancer Study subjects will be asked to complete a short survey designed to assess their understanding and opinions regarding breath testing
Trial Locations
- Locations (2)
Imperial College London
🇬🇧London, United Kingdom
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States