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NCT Number: NCT06302660

Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Oesophageal Cancer Bacterial Overgrowth Digestive System Diseases Digestive System Neoplasms Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Quality of Life

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breath test

Diagnostic Test

Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath.

Saliva sample

Diagnostic Test

Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of saliva.

Blood sample

Diagnostic Test

Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of blood.

Urine sample

Diagnostic Test

Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of urine.

Stool Sample

Diagnostic Test

Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of stool.

Health-related Quality of life questionnaires

Diagnostic Test

Participants will attend an outpatient clinic and complete validated healthy-related quality-of-life questionnaires.

Primary outcomes

  1. Identify microbiome dysbiosis in saliva associated with long-term functional symptoms.

    Time frame: 24 months

    Metagenomic sequencing of saliva samples.

  2. Identify microbiome dysbiosis in stool associated with long-term functional symptoms.

    Time frame: 24 months

    Metagenomic sequencing of stool samples.

Secondary outcomes

  1. Identify underlying metabolic pathways associated with microbiome derived metabolites.

    Time frame: 36 months

    Bioinformatic multi-omic pathway analysis.

  2. 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.

  3. 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

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

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

Registry information

Acronym: MAPLES

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2024
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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