Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT06302660
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-27
First Post:
2024-03-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001944', 'term': 'Breath Tests'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-24', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2025-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identify microbiome dysbiosis in saliva associated with long-term functional symptoms.', 'timeFrame': '24 months', 'description': 'Metagenomic sequencing of saliva samples.'}, {'measure': 'Identify microbiome dysbiosis in stool associated with long-term functional symptoms.', 'timeFrame': '24 months', 'description': 'Metagenomic sequencing of stool samples.'}], 'secondaryOutcomes': [{'measure': 'Identify underlying metabolic pathways associated with microbiome derived metabolites.', 'timeFrame': '36 months', 'description': 'Bioinformatic multi-omic pathway analysis.'}, {'measure': 'Develop a breath test to detect volatile biomarkers associated with microbiome dysbiosis.', 'timeFrame': '36 months', 'description': '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.'}, {'measure': 'Propose a strategy for treatment of long-term symptoms in oesophageal adenocarcinoma survivors.', 'timeFrame': '36 months', 'description': 'Identify therapeutic targets and interventions to manipulate dysbiotic microbiota'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oesophageal Cancer', 'Quality of Life', 'Bacterial Overgrowth']}, '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:\n\n* Study the changes in gut bacteria by examining saliva, stool and blood.\n* Investigate the products of bacteria in breath to develop a non-invasive breath test to detect the changes in gut bacteria.\n* Develop new strategies to treat this change and trial new treatments to improve quality- of-life in oesophageal cancer survivors.\n\nParticipants 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.\n\nResearchers will compare symptomatic and asymptomatic participants to detect the changes stated above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Disease free survivors who underwent curative treatment for oesophageal adenocarcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female patients aged 18-90 years\n* Patients who underwent oesophagectomy for oesophageal adenocarcinoma with curative intent\n* Disease free patients (CT with no evidence of recurrence within last 6 months or more than 5 years post oesophageal resection)\n* Patients more than 1 year post oesophageal resection\n\nExclusion Criteria:\n\n* Patients with Siewert III gastro-oesophageal junctional tumours\n* Patients with evidence of disease recurrence\n* Patients who are unable or unwilling to provide informed written consent\n* Patients who have received antibiotic therapy within the last 4 weeks'}, 'identificationModule': {'nctId': 'NCT06302660', 'acronym': 'MAPLES', 'briefTitle': 'Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors', 'organization': {'class': 'OTHER', 'fullName': 'Imperial College London'}, 'officialTitle': 'Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors', 'orgStudyIdInfo': {'id': '22/LO/0169'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Oesophageal adenocarcinoma survivors', 'description': '100 disease free survivors who underwent multimodality treatment for oesophageal adenocarcinoma and are \\>1 year post oesophagectomy', 'interventionNames': ['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']}], 'interventions': [{'name': 'Breath test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath.', 'armGroupLabels': ['Oesophageal adenocarcinoma survivors']}, {'name': 'Saliva sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of saliva.', 'armGroupLabels': ['Oesophageal adenocarcinoma survivors']}, {'name': 'Blood sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of blood.', 'armGroupLabels': ['Oesophageal adenocarcinoma survivors']}, {'name': 'Urine sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of urine.', 'armGroupLabels': ['Oesophageal adenocarcinoma survivors']}, {'name': 'Stool sample', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of stool.', 'armGroupLabels': ['Oesophageal adenocarcinoma survivors']}, {'name': 'Health-related Quality of life questionnaires', 'type': 'DIAGNOSTIC_TEST', 'description': 'Participants will attend an outpatient clinic and complete validated healthy-related quality-of-life questionnaires.', 'armGroupLabels': ['Oesophageal adenocarcinoma survivors']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Barking, Havering and Redbridge University Hospitals NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'Imperial College Healthcare NHS Trust', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'city': 'London', 'country': 'United Kingdom', 'facility': 'West Hertfordshire NHS Teaching Hospitals', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imperial College London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Imperial College Healthcare NHS Trust', 'class': 'OTHER'}, {'name': 'West Hertfordshire Teaching Hospitals NHS Trust', 'class': 'UNKNOWN'}, {'name': 'Barking, Havering and Redbridge University Hospitals NHS Trust', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}