Quality of Life Clinical Trial
— MAPLESOfficial title:
Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors
NCT number | NCT06302660 |
Other study ID # | 22/LO/0169 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 9, 2022 |
Est. completion date | June 1, 2025 |
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 1, 2025 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Barking, Havering and Redbridge University Hospitals NHS Trust | London | |
United Kingdom | Imperial College Healthcare NHS Trust | London | |
United Kingdom | West Hertfordshire NHS Teaching Hospitals | London |
Lead Sponsor | Collaborator |
---|---|
Imperial College London | Barking, Havering and Redbridge University Hospitals NHS Trust, Imperial College Healthcare NHS Trust, West Hertfordshire Teaching Hospitals NHS Trust |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Identify microbiome dysbiosis in saliva associated with long-term functional symptoms. | Metagenomic sequencing of saliva samples. | 24 months | |
Primary | Identify microbiome dysbiosis in stool associated with long-term functional symptoms. | Metagenomic sequencing of stool samples. | 24 months | |
Secondary | Identify underlying metabolic pathways associated with microbiome derived metabolites. | Bioinformatic multi-omic pathway analysis. | 36 months | |
Secondary | 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. | 36 months | |
Secondary | Propose a strategy for treatment of long-term symptoms in oesophageal adenocarcinoma survivors. | Identify therapeutic targets and interventions to manipulate dysbiotic microbiota | 36 months |
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