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Completed

NCT Number: NCT06453993

Temporal Variation in Exhaled Volatile Organic Compounds in Esophageal Cancer Patients

The purpose of this study is to investigate whether exhaled breath can be used to detect and monitor esophageal cancer.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Imperial College London, London, United Kingdom

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Exhaled VOC breath test

Other

To determine longitudinal variation in exhaled VOC concentrations during intended curative therapy for EC cancer.

Primary outcomes

  1. Exhaled breath and urinary VOC concentrations as biomarkers of esophageal cancer

    Time frame: 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 outcomes

  1. Changes in VOC concentrations that occur in response to therapeutic intervention

    Time frame: (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

  2. Linkage of longitudinal VOC data to predominant upper gastrointestinal bacterial species

    Time frame: (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

  3. Patient acceptability of breath test

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Benaroya Research Institute

Other

Collaborators

  • Imperial College London

Registry information

Official study title

Temporal Variation in Exhaled Volatile Organic Compounds in Response to Therapeutic Intervention in Esophageal Cancer Patients

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 12, 2024
Registry last updated
Aug 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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