Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors

Active, not recruiting

• Conditions: Quality of Life; Bacterial Overgrowth; Oesophageal Cancer
• Interventions: Diagnostic Test: Breath test; Diagnostic Test: Saliva sample; Diagnostic Test: Blood sample; Diagnostic Test: Urine sample; Diagnostic Test: Stool sample; Diagnostic Test: Health-related Quality of life questionnaires

• Registration Number: NCT06302660
• Lead Sponsor: Imperial College London

Brief Summary

The goal of this observational study is to learn about long term symptoms in oesophageal cancer survivors. The main question it aims to answer is are:

* Study the changes in gut bacteria by examining saliva, stool and blood.

* Investigate the products of bacteria in breath to develop a non-invasive breath test to detect the changes in gut bacteria.

* Develop new strategies to treat this change and trial new treatments to improve quality- of-life in oesophageal cancer survivors.

Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath, saliva, blood, urine, stool and complete validated healthy-related quality-of-life questionnaires.

Researchers will compare symptomatic and asymptomatic participants to detect the changes stated above.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-09
• Study First Submitted: 2024-03-04
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27
• Primary Completion: 2025-10-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Male and female patients aged 18-90 years
• Patients who underwent oesophagectomy for oesophageal adenocarcinoma with curative intent
• Disease free patients (CT with no evidence of recurrence within last 6 months or more than 5 years post oesophageal resection)
• Patients more than 1 year post oesophageal resection

Exclusion Criteria

• Patients with Siewert III gastro-oesophageal junctional tumours
• Patients with evidence of disease recurrence
• Patients who are unable or unwilling to provide informed written consent
• Patients who have received antibiotic therapy within the last 4 weeks

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oesophageal adenocarcinoma survivors	Stool sample	100 disease free survivors who underwent multimodality treatment for oesophageal adenocarcinoma and are \>1 year post oesophagectomy
Oesophageal adenocarcinoma survivors	Urine sample	100 disease free survivors who underwent multimodality treatment for oesophageal adenocarcinoma and are \>1 year post oesophagectomy
Oesophageal adenocarcinoma survivors	Saliva sample	100 disease free survivors who underwent multimodality treatment for oesophageal adenocarcinoma and are \>1 year post oesophagectomy
Oesophageal adenocarcinoma survivors	Breath test	100 disease free survivors who underwent multimodality treatment for oesophageal adenocarcinoma and are \>1 year post oesophagectomy
Oesophageal adenocarcinoma survivors	Blood sample	100 disease free survivors who underwent multimodality treatment for oesophageal adenocarcinoma and are \>1 year post oesophagectomy
Oesophageal adenocarcinoma survivors	Health-related Quality of life questionnaires	100 disease free survivors who underwent multimodality treatment for oesophageal adenocarcinoma and are \>1 year post oesophagectomy

Primary Outcome Measures

Name	Time	Method
Identify microbiome dysbiosis in stool associated with long-term functional symptoms.	24 months	Metagenomic sequencing of stool samples.
Identify microbiome dysbiosis in saliva associated with long-term functional symptoms.	24 months	Metagenomic sequencing of saliva samples.

Secondary Outcome Measures

Name	Time	Method
Identify underlying metabolic pathways associated with microbiome derived metabolites.	36 months	Bioinformatic multi-omic pathway analysis.
Develop a breath test to detect volatile biomarkers associated with microbiome dysbiosis.	36 months	Gas Chromatography-Mass Spectrometry (GC-MS) will be used to identify the levels (measured in parts per billion, ppb) of certain microbiome-derived VOCs in breath.
Propose a strategy for treatment of long-term symptoms in oesophageal adenocarcinoma survivors.	36 months	Identify therapeutic targets and interventions to manipulate dysbiotic microbiota

Trial Locations

Locations (3)

Barking, Havering and Redbridge University Hospitals NHS Trust; 🇬🇧 London, United Kingdom

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom

West Hertfordshire NHS Teaching Hospitals; 🇬🇧 London, United Kingdom