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Not Yet Recruiting NCT05600608

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

Conditions: Breath Test, Oesophageal Cancer, Gastric Cancer, Augmentation, Diagnoses Disease

Sex: All
Ages: 19 Years – 90 Years
Healthy volunteers: 1
Phase: NA
Enrollment: 100
Sponsor: Anuja Mitra

Location: United Kingdom

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.

Eligibility Criteria

Inclusion Criteria:Participants should be over 18 years old and up to the maximal age of 90 years , AND:Have a confirmed histological diagnosis of oesophageal OR gastric adenocarcinoma at Imperial NHS Healthcare Trust, ANDWill undergo am oesophagogastroscopy (OGD) as part of their routine clinical care, OR:Will undergo surgical resection of their oesophageal or gastric cancer as part of their routine clinical care ORAny patient with non- cancerous upper gastrointestinal (benign) problem who will have an OGD OR surgery as part of their routine clinical care at Imperial NHS TrustExclusion Criteria:Participant that lacks capacity or is unable to provide informed consentAny participant below 18 years of age or over 90 years of ageParticipants with allergies to any aspect of the metabolic drinkParticipants who have had previous OG surgical resection

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05600608). StuddyBuddy aggregates publicly available trial information.