Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors (MAPLES)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Oesophageal Cancer; Bacterial Overgrowth
• Intervention / Treatment: 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

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom
    • Imperial College Healthcare NHS Trust
  • London, United Kingdom
    • Barking, Havering and Redbridge University Hospitals NHS Trust
  • London, United Kingdom
    • West Hertfordshire NHS Teaching Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Disease free survivors who underwent curative treatment for oesophageal adenocarcinoma

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Oesophageal adenocarcinoma survivors; 100 disease free survivors who underwent multimodality treatment for oesophageal adenocarcinoma and are >1 year post oesophagectomy

Diagnostic test: Breath test; Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath.; Diagnostic test: Saliva sample; Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of saliva.; Diagnostic test: Blood sample; Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of blood.; Diagnostic test: Urine sample; Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of urine.; Diagnostic test: Stool sample; Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of stool.; Diagnostic test: Health-related Quality of life questionnaires; Participants will attend an outpatient clinic and complete validated healthy-related quality-of-life questionnaires.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify microbiome dysbiosis in stool associated with long-term functional symptoms.	Metagenomic sequencing of stool samples.	24 months
Identify microbiome dysbiosis in saliva associated with long-term functional symptoms.	Metagenomic sequencing of saliva samples.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Develop a breath test to detect volatile biomarkers associated with microbiome dysbiosis.	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.	36 months
Propose a strategy for treatment of long-term symptoms in oesophageal adenocarcinoma survivors.	Identify therapeutic targets and interventions to manipulate dysbiotic microbiota	36 months
Identify underlying metabolic pathways associated with microbiome derived metabolites.	Bioinformatic multi-omic pathway analysis.	36 months

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: Barking, Havering and Redbridge University Hospitals NHS Trust; Imperial College Healthcare NHS Trust; West Hertfordshire Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2022
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 24, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 22/LO/0169

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No