Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer

What this Trial Is About

Cancer of the stomach and oesophagus ranks among the world's top five cancers, with poor survival rates due to late presentation and non-specific early symptoms. Researchers are evaluating a non-invasive breath test that detects volatile organic compounds (VOCs) produced by these cancers and associated bacteria. The study aims to improve this test's accuracy by investigating if consuming simple metabolic substrates can increase VOC production from tumors and their bacteria. The study involves two components: AROMA 1 and BIORESOURCE. AROMA 1 will recruit 648 patients divided into three groups: oesophageal cancer, gastric cancer, and control patients with upper gastrointestinal symptoms. Participants will provide breath samples before and after consuming a standard nutrient drink, with samples analyzed using advanced mass spectrometry techniques. BIORESOURCE will collect biosamples including breath, urine, saliva, blood, tissue, and gastric contents from 335 patients for in-depth analysis such as volatalomics, metabonomics, microbiome, transcriptomics, and cell culture studies. Participants will undergo breath sampling at baseline and shortly after the nutrient drink consumption. Biosamples collected in BIORESOURCE will support multi-omic analyses to study VOC production mechanisms. Researchers will measure the efficacy of the nutrient drink in stimulating VOCs in breath over 18 months, along with profiling metabolites and bacteria from various samples. The study includes safety monitoring and will last up to October 2025, with participants followed through treatment-naive stages and control evaluations.

Augmented Response of Volatile Biomarkers in Assessment of Oesophagogastric Cancer (AROMA 1 / BIORESOURCE)