NCT06169163

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
518

participants targeted

Target at P75+ for all trials

Timeline
8mo left

Started Dec 2023

Typical duration for all trials

Geographic Reach
1 country

13 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Dec 2023Dec 2026

First Submitted

Initial submission to the registry

November 24, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

December 1, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 13, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 2, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

November 24, 2023

Last Update Submit

April 29, 2025

Conditions

Oesophageal Squamous Cell CarcinomaOesophageal Cancer

Keywords

Breath biomarkerEarly detectionOesophageal cancerOesophageal squamous cell cancerVolatile organic compounds

Outcome Measures

Primary Outcomes (1)

  • To develop a breath test for detection of OSCC

    The investigators hypothesise that breath VOCs in OSCC are unique and different to those in non-cancer patients. Replicate breath samples will be analysed by two independent assays using different Thermal Desorption - Gas Chromatography - Time of Flight Mass Spectrometry (TD-GC-TOF-MS) instruments. One assay will use a mid-polar, and the other a polar column stationary phase for optimal determination of VOC chemical classes. The samples will then be recollected and analysed by two-dimensional (2D) TD-GC-TOF-MS for robust VOC identification. Confirming the identity of the top VOCs driving the model will provide chemical validation. Data obtained will be used to refine the model using molecular network analysis. Statistical methods will estimate the probability of OSCC as a function of measured VOCs. Calibrations and method validation will be used to assess and correct for discrimination.

    36 months

Secondary Outcomes (1)

  • To evaluate the effects of known confounding variables on the target VOCs in OSCC

    36 months

Study Arms (2)

OSCC group

Patients with histopathology confirmed, treatment naive OSCC

Other: Exhaled breath sampling

Non-cancer controls

Patients who are undergoing an endoscopy for non-specific upper gastrointestinal (GI) symptoms and are shown to have either: 1. A healthy upper GI tract 2. Benign upper gastrointestinal disease

Other: Exhaled breath sampling

Interventions

Exhaled breath samplingOTHER

Participants will maintain a clear fluid diet for a minimum of 6 hours prior to breath collection. Participants will be asked to provide a breath sample by exhaling into single-use breath collection bags. Using a custom designed gas sampling pump, the breath VOCs will be transferred onto TD tubes at a controlled flow rate. This breath sampling procedure will be repeated once. When the participants' breath sampling is complete, room air (Blank) samples must be taken onto additional TD tubes using the same procedure. The TD tubes will be sealed with long-term storage caps using the CapLok Tool.

Non-cancer controlsOSCC group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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).

You may qualify if:

  • Cancer cohort (n=259): Patients with treatment naïve, histopathology confirmed OSCC.
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Imperial College Healthcare NHS Trust

London, Greater London, W12 0NN, United Kingdom

RECRUITING

Hull University Teaching Hospitals NHS Trust

Cottingham, Hull, United Kingdom

RECRUITING

Cardiff and Vale University Health Board

Cardiff, United Kingdom

NOT YET RECRUITING

Velindre NHS Trust

Cardiff, United Kingdom

NOT YET RECRUITING

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, United Kingdom

RECRUITING

University Hospitals of Leicester NHS Foundation Trust

Leicester, United Kingdom

RECRUITING

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

NOT YET RECRUITING

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, United Kingdom

RECRUITING

Bedfordshire Hospitals NHS Foundation Trust

Luton, United Kingdom

NOT YET RECRUITING

Newcastle Upon Tyne Hospitals NHS Trust

Newcastle, United Kingdom

RECRUITING

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, United Kingdom

RECRUITING

Oxford University Hospitals NHS Trust

Oxford, United Kingdom

RECRUITING

Portsmouth Hospitals University NHS Trust

Portsmouth, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell CarcinomaEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Squamous CellCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Squamous CellGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Central Study Contacts

Sameera Sharma, MBBS; MRCS

CONTACT

07576583519vison@imperial.ac.uk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2023

First Posted

December 13, 2023

Study Start

December 1, 2023

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 2, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

GB(13)