Clinical trial NCT06302660: Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors
Official title: Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Oesophageal Cancer
Quality of Life
Bacterial Overgrowth
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
name: West Hertfordshire Teaching Hospitals NHS Trust
name: Barking, Havering and Redbridge University Hospitals NHS Trust
First posted: 2024-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Disease free survivors who underwent curative treatment for oesophageal adenocarcinoma

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.


Eligibility criteria: 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

Primary outcomes:
measure: Identify microbiome dysbiosis in saliva associated with long-term functional symptoms.
timeFrame: 24 months
measure: Identify microbiome dysbiosis in stool associated with long-term functional symptoms.
timeFrame: 24 months
Secondary outcomes:
measure: Identify underlying metabolic pathways associated with microbiome derived metabolites.
timeFrame: 36 months
measure: Develop a breath test to detect volatile biomarkers associated with microbiome dysbiosis.
timeFrame: 36 months
measure: Propose a strategy for treatment of long-term symptoms in oesophageal adenocarcinoma survivors.
timeFrame: 36 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barking, Havering and Redbridge University Hospitals NHS Trust
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: London
country: United Kingdom
facility: West Hertfordshire NHS Teaching Hospitals
Study officials:
References: