Bacterial Overgrowth, Oesophageal Cancer, Quality of Life
Conditions
Brief 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. * 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.
Interventions
DIAGNOSTIC_TESTBreath test
Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath.
DIAGNOSTIC_TESTSaliva sample
Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of saliva.
DIAGNOSTIC_TESTBlood sample
Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of blood.
DIAGNOSTIC_TESTUrine sample
Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of urine.
DIAGNOSTIC_TESTStool sample
Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of stool.
DIAGNOSTIC_TESTHealth-related Quality of life questionnaires
Participants will attend an outpatient clinic and complete validated healthy-related quality-of-life questionnaires.
Sponsors
Imperial College Healthcare NHS Trust
West Hertfordshire Teaching Hospitals NHS Trust
Barking, Havering and Redbridge University Hospitals NHS Trust
Imperial College London
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Identify microbiome dysbiosis in saliva associated with long-term functional symptoms. | 24 months | Metagenomic sequencing of saliva samples. |
| Identify microbiome dysbiosis in stool associated with long-term functional symptoms. | 24 months | Metagenomic sequencing of stool samples. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identify underlying metabolic pathways associated with microbiome derived metabolites. | 36 months | Bioinformatic multi-omic pathway analysis. |
| Develop a breath test to detect volatile biomarkers associated with microbiome dysbiosis. | 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. |
| Propose a strategy for treatment of long-term symptoms in oesophageal adenocarcinoma survivors. | 36 months | Identify therapeutic targets and interventions to manipulate dysbiotic microbiota |
Countries
United Kingdom
Outcome results
None listed