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Augmentation of Volatile Biomarkers of Oesophageal and Gastric Adenocarcinoma From the Tumour Lipidome

NCT05600608 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-11-02

No results posted yet for this study

Summary

Nearly 10,000 people die each year in the United Kingdom from cancer of the lower gullet and stomach, known as known as oesophago- gastric adenocarcinoma (OGC). OGC is detected late as symptoms are non- specific and often mistaken for common problems such as heartburn. This translates to fewer than 2 in every 10 patients diagnosed with OGC living longer than 5 years.

The breath of people with OGC is enriched with volatile chemicals (VOCs) that indicate cancer. When measured in a breath test, it detects OAC 80 out of 100 times. Whilst encouraging, there is scope to improve the detection rate by giving patients a stimulant drink that amplifies the production of tumour specific VOCs only, to increase their detection in the breath test.

The goal of this observational study is to produce an enhanced second-generation breath test with superior ability to detect OGC through augmentation of breath. This will improve long term survival from cancer using an entirely non- invasive test.

All participants (cancer and control participants) will consume an oral stimulant drink (OSD) and provide breath samples pre and post consumption of the drink at set time points (maximum 2 hours after consumption of the drink).

The investigators will compare the breath VOCs from both groups, before and after consumption of the OSD to see if the OSD has a desired augmentation effect and can improve the accuracy of the OGC breath test.

With this second-generation breath test, participants with vague symptoms can undergo a quick, non- invasive test, have samples analysed in a safe and accurate manner and be subsequently stratified based on their risk of having OGC, leading to earlier disease detection and improved clinical outcomes.

Conditions

  • Breath Test
  • Oesophageal Cancer
  • Gastric Cancer
  • Augmentation
  • Diagnoses Disease

Interventions

DIETARY_SUPPLEMENT

Oral Stimulant Drink

please see description of the drink in the arm/ group section

Sponsors & Collaborators

  • British Medical Research Council

    collaborator OTHER_GOV

  • British Association of Surgical Oncology

    collaborator UNKNOWN

  • The Royal College of Surgeons of England

    collaborator OTHER

  • Anuja Mitra

    lead OTHER

Principal Investigators

  • George B Hanna, FMedSci · Imperial College London

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2023-04-30
Completion
2023-12-20

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05600608 on ClinicalTrials.gov