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

January 24, 2025 updated by: Imperial College London

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

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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.
Time Frame: 24 months
Metagenomic sequencing of stool samples.
24 months
Identify microbiome dysbiosis in saliva associated with long-term functional symptoms.
Time Frame: 24 months
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.
Time Frame: 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.
36 months
Propose a strategy for treatment of long-term symptoms in oesophageal adenocarcinoma survivors.
Time Frame: 36 months
Identify therapeutic targets and interventions to manipulate dysbiotic microbiota
36 months
Identify underlying metabolic pathways associated with microbiome derived metabolites.
Time Frame: 36 months
Bioinformatic multi-omic pathway analysis.
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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