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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Imperial College London

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 9, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 4, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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