Clinical trial NCT06453993: Temporal Variation in Exhaled Volatile Organic Compounds in Esophageal Cancer Patients
Official title: Temporal Variation in Exhaled Volatile Organic Compounds in Response to Therapeutic Intervention in Esophageal Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Lead sponsor: Benaroya Research Institute
Sponsor class: OTHER
Collaborators: name: Imperial College London
First posted: 2024-06-12
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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

Eligibility criteria: 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

Primary outcomes:
measure: Exhaled breath and urinary VOC concentrations as biomarkers of esophageal cancer
timeFrame: Before commencing treatment for esophageal cancer
Secondary outcomes:
measure: Changes in VOC concentrations that occur in response to therapeutic intervention
timeFrame: (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)
measure: Linkage of longitudinal VOC data to predominant upper gastrointestinal bacterial species
timeFrame: (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)
measure: Patient acceptability of breath test
timeFrame: Before commencing treatment for esophogeal cancer
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: London
country: United Kingdom
facility: Imperial College London
Study officials:
affiliation: Virginia Mason Medical Center
name: Donald E Low, MD
role: PRINCIPAL_INVESTIGATOR
References:
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 Organic Compounds Are Detectable in Exhaled Breath during Pulmonary Infection. Am J Respir Crit Care Med. 2021 Nov 1;204(9):1075-1085. doi: 10.1164/rccm.202103-0660OC.
citation: 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 exhaled biomarkers in esophageal adenocarcinoma. Nat Commun. 2021 Mar 5;12(1):1454. doi: 10.1038/s41467-021-21800-5.