Temporal Variation in Exhaled Volatile Organic Compounds in Esophageal Cancer Patients

NCT06453993 | Completed

• 1 other identifier: CRP19015
• Study Type: interventional
• Target: 46
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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)

• 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)

• Patient acceptability of breath test

  Before commencing treatment for esophogeal cancer

Study Arms (1)

Investigate whether exhaled breath can be used to detect and monitor esophageal cancer.

OTHER

The procedures will include collecting participant's personal information and samples of participant's exhaled breath, urine, and saliva.

Other: Exhaled VOC breath test

Interventions

Exhaled VOC breath test OTHER

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

Investigate whether exhaled breath can be used to detect and monitor esophageal cancer.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benaroya Research Institute: lead
• Imperial College London: collaborator

Study Sites (2)

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Imperial College London

London, W2 1NY, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 34319857 RESULT

• 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.

  PMID: 33674602 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Study Officials

• Donald E Low, MD

  Virginia Mason Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: June 12, 2024
• Study Start: December 1, 2019
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: August 27, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (1)