Clinical trial NCT06169163: Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms
Official title: Volatile Organic Compounds as Breath Biomarkers in Squamous Oesophageal Neoplasms
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oesophageal Squamous Cell Carcinoma
Oesophageal Cancer
Keywords: Breath biomarker
Early detection
Oesophageal cancer
Oesophageal squamous cell cancer
Volatile organic compounds
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
name: Hull University Teaching Hospitals NHS Trust
name: Norfolk and Norwich University Hospitals NHS Foundation Trust
name: University Hospitals Coventry and Warwickshire NHS Trust
name: Oxford University Hospitals NHS Trust
name: Velindre NHS Trust
name: Cardiff and Vale University Health Board
name: Newcastle-upon-Tyne Hospitals NHS Trust
name: Liverpool University Hospitals NHS Foundation Trust
name: Bedfordshire Hospitals NHS Foundation Trust
name: University Hospitals, Leicester
name: The Clatterbridge Cancer Centre NHS Foundation Trust
name: Portsmouth Hospitals NHS Trust
name: University Hospital Plymouth NHS Trust
name: NHS Tayside
name: NHS Highlands
name: The Christie NHS Foundation Trust
name: North Cumbria University Hospitals NHS Trust
name: Maidstone & Tunbridge Wells NHS Trust
name: University Hospitals of Derby and Burton NHS Foundation Trust
name: Bradford Teaching Hospitals NHS Foundation Trust
name: East and North Hertfordshire NHS Trust
First posted: 2023-12-13
Enrollment: 518
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with treatment naïve OSCC will be identified via the weekly multidisciplinary team (MDT) meetings (OSCC group). Patients undergoing an OGD for upper GI symptoms will be identified using the National Health Services (NHS) trust booking systems (Control group).

Brief summary: Oesophageal Squamous Cell Carcinoma (OSCC) is a cancer of the food pipe that affects around 2000 patients in the UK every year. It is often detected at an advanced stage, resulting in poor survival (5-year survival less than 20%). Early detection can improve survival (5-year survival \>70%). Therefore, early detection is vital to improving survival.

There are no national screening guidelines, and an endoscopy (A camera test to look at the food pipe) is the only available test to detect OSCC.

Early detection of OSCC is challenging for many reasons. Firstly, early disease symptoms are non-specific, which patients often overlook. Secondly, 'Alarm' symptoms such as weight loss, difficulty swallowing or vomiting blood are signs of advanced stage. Lastly, endoscopy is an invasive test with associated risks and significant discomfort.

The investigators propose to develop a breath test for patients with non-specific symptoms. Breath testing has the ideal characteristics for a triage test because it is non-invasive, simple to perform, cost-effective and highly acceptable to patients. The test is based on identifying volatile organic compounds (VOCs, small molecules) that are produced by the cancer and released in breath.

The breath test will be offered by General Practitioners (GPs) to patients with non-specific symptoms. Those who test positive will be referred for an urgent camera test, and those who test negative can be reassured.

Detailed description: In this prospective multicentre case-control study, the investigators will recruit a total of 518 patients. These will be divided into the following groups:

1. Cancer group (n=259): Patients with treatment naive, histopathology confirmed OSCC.
2. Control group (n=259): Patients who have undergone or are undergoing an upper gastrointestinal (GI) endoscopy as part of their investigation for upper GI symptoms and are found to have either - (i) A normal upper GI tract or (ii) Benign upper GI disease.

Eligible and willing participants will be asked to provide two breath samples by exhaling into single-use breath collection bags. Using a custom designed gas sampling pump, the breath VOCs will be transferred onto thermal desorption (TD) tubes at a controlled flow rate. When the participants' breath sampling is complete, room air (Blank) samples will be taken onto additional TD tubes using the same process.

Once collected, the TD tubes will be transported to Imperial College London (The Hanna lab), where they will be analysed.

Eligibility criteria: Inclusion Criteria: Participants with all the following characteristics will be eligible for inclusion in the study:

1. Cancer cohort (n=259): Patients with treatment naïve, histopathology confirmed OSCC.
2. Control cohort (n=259): Patients who have undergone or are undergoing an endoscopy (OGD) as part of their investigation for upper GI symptoms and are found to have either:

   * A normal upper gastrointestinal tract
   * Benign upper gastrointestinal disease

Exclusion Criteria: Participants with the following characteristics will not be eligible for inclusion in the study:

1. Received some form of treatment (chemotherapy, radiotherapy, immunotherapy, endoscopic resection, or surgery) for OSCC
2. History of another cancer in the last five years
3. Non-squamous cell oesophageal cancer
4. Barrett's oesophagus (with or without dysplasia)
5. Previous oesophageal or gastric resection
6. Unable to provide written consent or lack capacity.
7. Pregnant women

Primary outcomes:
measure: To develop a breath test for detection of OSCC
timeFrame: 36 months
Secondary outcomes:
measure: To evaluate the effects of known confounding variables on the target VOCs in OSCC
timeFrame: 36 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
state: Greater London
city: Cottingham
country: United Kingdom
facility: Hull University Teaching Hospitals NHS Trust
state: Hull
city: Cardiff
country: United Kingdom
facility: Cardiff and Vale University Health Board
city: Cardiff
country: United Kingdom
facility: Velindre NHS Trust
city: Coventry
country: United Kingdom
facility: University Hospitals Coventry and Warwickshire NHS Trust
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: Liverpool University Hospitals NHS Foundation Trust
city: Liverpool
country: United Kingdom
facility: The Clatterbridge Cancer Centre NHS Foundation Trust
city: Luton
country: United Kingdom
facility: Bedfordshire Hospitals NHS Foundation Trust
city: Newcastle
country: United Kingdom
facility: Newcastle Upon Tyne Hospitals NHS Trust
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospitals NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals University NHS Trust
Study officials:
References: