Oesophageal CancerMAPLESNCT06302660
Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors
An observational study of Oesophageal Cancer and Quality of Life, run by Imperial College London at 3 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Oesophageal Cancer, Quality of Life, Bacterial Overgrowth
- What is being tested?
- Breath test, Saliva sample and Blood sample
- How many people
- 100 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 9 Mar 2022to 1 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Disease free survivors who underwent curative treatment for oesophageal adenocarcinoma
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United Kingdom3 sites
Barking, Havering and Redbridge University Hospitals NHS Trust
London
Imperial College Healthcare NHS Trust
London
West Hertfordshire NHS Teaching Hospitals
London
About this study
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.
Read more
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.
- Conditions
- Oesophageal Cancer, Quality of Life, Bacterial Overgrowth
- Being tested
- Breath test, Saliva sample, Blood sample, Urine sample, Stool sample
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath testDiagnostic test
Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath.
Saliva sampleDiagnostic test
Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of saliva.
Blood sampleDiagnostic test
Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of blood.
Urine sampleDiagnostic test
Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of urine.
Stool sampleDiagnostic test
Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of stool.
Health-related Quality of life questionnairesDiagnostic test
Participants will attend an outpatient clinic and complete validated healthy-related quality-of-life questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Oesophageal adenocarcinoma survivors | 100 disease free survivors who underwent multimodality treatment for oesophageal adenocarcinoma and are >1 year post oesophagectomy Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify microbiome dysbiosis in saliva associated with long-term functional symptoms.
Metagenomic sequencing of saliva samples.
Measured: 24 months
Identify microbiome dysbiosis in stool associated with long-term functional symptoms.
Metagenomic sequencing of stool samples.
Measured: 24 months
Secondary outcomes (3)
Identify underlying metabolic pathways associated with microbiome derived metabolites.
Bioinformatic multi-omic pathway analysis.
Measured: 36 months
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.
Measured: 36 months
Propose a strategy for treatment of long-term symptoms in oesophageal adenocarcinoma survivors.
Identify therapeutic targets and interventions to manipulate dysbiotic microbiota
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start9 Mar 2022
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oesophageal CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, West Hertfordshire Teaching Hospitals NHS Trust, Barking, Havering and Redbridge University Hospitals NHS Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302660
- Sponsor's protocol ID
- 22/LO/0169
- Acronym
- MAPLES
- Status last verified
- Jan 2025
- First submitted
- 4 Mar 2024
- Last updated
- 27 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors
- ClinicalTrials.gov ID
- NCT06302660
- Acronym / sponsor ID
- MAPLES / 22/LO/0169
- Conditions
- Oesophageal Cancer, Quality of Life, Bacterial Overgrowth
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Imperial College Healthcare NHS Trust, West Hertfordshire Teaching Hospitals NHS Trust, Barking, Havering and Redbridge University Hospitals NHS Trust
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oesophageal adenocarcinoma survivors | – | 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 questionnaires100 disease free survivors who underwent multimodality treatment for oesophageal adenocarcinoma and are >1 year post oesophagectomy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Disease free survivors who underwent curative treatment for oesophageal adenocarcinoma
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breath testParticipants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath. | Diagnostic test | Oesophageal adenocarcinoma survivors |
| Saliva sampleParticipants will attend an outpatient clinic, fasted for at least 4 hours for collection of saliva. | Diagnostic test | Oesophageal adenocarcinoma survivors |
| Blood sampleParticipants will attend an outpatient clinic, fasted for at least 4 hours for collection of blood. | Diagnostic test | Oesophageal adenocarcinoma survivors |
| Urine sampleParticipants will attend an outpatient clinic, fasted for at least 4 hours for collection of urine. | Diagnostic test | Oesophageal adenocarcinoma survivors |
| Stool sampleParticipants will attend an outpatient clinic, fasted for at least 4 hours for collection of stool. | Diagnostic test | Oesophageal adenocarcinoma survivors |
| Health-related Quality of life questionnairesParticipants will attend an outpatient clinic and complete validated healthy-related quality-of-life questionnaires. | Diagnostic test | Oesophageal adenocarcinoma survivors |
Primary outcome
Identify microbiome dysbiosis in saliva associated with long-term functional symptoms.
Time frame: 24 months
Metagenomic sequencing of saliva samples.
Identify microbiome dysbiosis in stool associated with long-term functional symptoms.
Time frame: 24 months
Metagenomic sequencing of stool samples.
3 secondary outcomes
Identify underlying metabolic pathways associated with microbiome derived metabolites.
Time frame: 36 months
Develop a breath test to detect volatile biomarkers associated with microbiome dysbiosis.
Time frame: 36 months
Propose a strategy for treatment of long-term symptoms in oesophageal adenocarcinoma survivors.
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oesophageal Cancer and Quality of Life, run by Imperial College London at 3 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify microbiome dysbiosis in saliva associated with long-term functional symptoms. (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.