Temporal Variation in Exhaled Volatile Organic Compounds in Esophageal Cancer Patients

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06453993
• Other study ID #: CRP19015
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2019
• Est. completion date: June 28, 2024

Study information

• Verified date: June 2024
• Source: Benaroya Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: June 28, 2024
• Est. primary completion date: December 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Other:
• Exhaled VOC breath test
To determine longitudinal variation in exhaled VOC concentrations during intended curative therapy for EC cancer.

Locations

Country	Name	City	State
United Kingdom	Imperial College London	London
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Benaroya Research Institute	Imperial College London

Countries where clinical trial is conducted

United States,  United Kingdom, 

References & Publications (2)

Antonowicz S, Bodai Z, Wiggins T, Markar SR, Boshier PR, Goh YM, Adam ME, Lu H, Kudo H, Rosini F, Goldin R, Moralli D, Green CM, Peters CJ, Habib N, Gabra H, Fitzgerald RC, Takats Z, Hanna GB. Endogenous aldehyde accumulation generates genotoxicity and ex — View Citation

Kamal F, Kumar S, Edwards MR, Veselkov K, Belluomo I, Kebadze T, Romano A, Trujillo-Torralbo MB, Shahridan Faiez T, Walton R, Ritchie AI, Wiseman DJ, Laponogov I, Donaldson G, Wedzicha JA, Johnston SL, Singanayagam A, Hanna GB. Virus-induced Volatile Orga — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exhaled breath and urinary VOC concentrations as biomarkers of 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	Before commencing treatment for esophageal cancer
Secondary	Changes in VOC concentrations that occur in response to therapeutic intervention	VOC concentrations in exhaled breath and urinary samples will be assessed longitudinally to assess how VOC concentrations change 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)
Secondary	Linkage of longitudinal VOC data to predominant upper gastrointestinal bacterial species	Bacterial RNA will be extracted from saliva samples to identify bacterial composition. Bacterial composition will then be correlated with breath and urinary VOC levels	(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)
Secondary	Patient acceptability of breath test	Study subjects will be asked to complete a short survey designed to assess their understanding and opinions regarding breath testing	Before commencing treatment for esophogeal cancer