protocolSection identificationModule nctId: NCT06302660, orgStudyIdInfo id: 22/LO/0169, briefTitle: Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors, acronym: MAPLES, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-03-09, primaryCompletionDateStruct date: 2024-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-04-18, sponsorCollaboratorsModule leadSponsor name: Imperial College London, class: OTHER, collaborators name: Imperial College Healthcare NHS Trust, collaborators name: West Hertfordshire Teaching Hospitals NHS Trust, collaborators name: Barking, Havering and Redbridge University Hospitals NHS Trust, descriptionModule briefSummary: 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., conditionsModule conditions: Oesophageal Cancer, conditions: Quality of Life, conditions: Bacterial Overgrowth, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Breath test, interventions name: Saliva sample, interventions name: Blood sample, interventions name: Urine sample, interventions name: Stool sample, interventions name: Health-related Quality of life questionnaires, outcomesModule primaryOutcomes measure: Identify microbiome dysbiosis in saliva associated with long-term functional symptoms., primaryOutcomes measure: Identify microbiome dysbiosis in stool associated with long-term functional symptoms., secondaryOutcomes measure: Identify underlying metabolic pathways associated with microbiome derived metabolites., secondaryOutcomes measure: Develop a breath test to detect volatile biomarkers associated with microbiome dysbiosis., secondaryOutcomes measure: Propose a strategy for treatment of long-term symptoms in oesophageal adenocarcinoma survivors., eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Barking, Havering and Redbridge University Hospitals NHS Trust, status: RECRUITING, city: London, country: United Kingdom, contacts name: Munir Tarazi, MB BCh BAO MRCS MCh, role: CONTACT, phone: +44 (0)20 7594 8197, email: m.tarazi@imperial.ac.uk, geoPoint lat: 51.50853, lon: -0.12574, locations facility: Imperial College Healthcare NHS Trust, status: RECRUITING, city: London, country: United Kingdom, contacts name: Munir Tarazi, MB BCh BAO MRCS MCh, role: CONTACT, phone: +44 (0)20 7594 8197, email: m.tarazi@imperial.ac.uk, geoPoint lat: 51.50853, lon: -0.12574, locations facility: West Hertfordshire NHS Teaching Hospitals, status: RECRUITING, city: London, country: United Kingdom, contacts name: Munir Tarazi, MB BCh BAO MRCS MCh, role: CONTACT, phone: +44 (0)20 7594 8197, email: m.tarazi@imperial.ac.uk, geoPoint lat: 51.50853, lon: -0.12574, hasResults: False