Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors

Quality of Life Clinical Trial

— MAPLES  

Official title:

Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06302660
• Other study ID #: 22/LO/0169
• Status: Recruiting
• Start date: March 9, 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2024
• Source: Imperial College London
• Contact: Dr Munir Tarazi, MB BCh BAO MRCS MCh
• Phone: +44 (0)20 7594 8197
• Email: m.tarazi[@]imperial.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Bacterial Overgrowth
• Esophageal Neoplasms
• Oesophageal Cancer
• Quality of Life

Intervention

Diagnostic Test:
• Breath test
Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath.
• Saliva sample
Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of saliva.
• Blood sample
Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of blood.
• Urine sample
Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of urine.
• Stool sample
Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of stool.
• Health-related Quality of life questionnaires
Participants will attend an outpatient clinic and complete validated healthy-related quality-of-life questionnaires.

Locations

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

Sponsors (4)

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

Country where clinical trial is conducted

United Kingdom, 

Outcome

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