Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors

NCT06302660 | Active Not Recruiting

• 1 other identifier: 22/LO/0169
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 3

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.

Conditions

Oesophageal Cancer; Quality of Life; Bacterial Overgrowth

Outcome Measures

Primary Outcomes (2)

• Identify microbiome dysbiosis in saliva associated with long-term functional symptoms.

  Metagenomic sequencing of saliva samples.

  24 months

• Identify microbiome dysbiosis in stool associated with long-term functional symptoms.

  Metagenomic sequencing of stool samples.

  24 months

Secondary Outcomes (3)

• Identify underlying metabolic pathways associated with microbiome derived metabolites.

  36 months

• Develop a breath test to detect volatile biomarkers associated with microbiome dysbiosis.

  36 months

• Propose a strategy for treatment of long-term symptoms in oesophageal adenocarcinoma survivors.

  36 months

Study Arms (1)

Oesophageal adenocarcinoma survivors

100 disease free survivors who underwent multimodality treatment for oesophageal adenocarcinoma and are \>1 year post oesophagectomy

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

Breath test DIAGNOSTIC_TEST

Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of breath.

Oesophageal adenocarcinoma survivors

Saliva sample DIAGNOSTIC_TEST

Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of saliva.

Oesophageal adenocarcinoma survivors

Blood sample DIAGNOSTIC_TEST

Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of blood.

Oesophageal adenocarcinoma survivors

Urine sample DIAGNOSTIC_TEST

Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of urine.

Oesophageal adenocarcinoma survivors

Stool sample DIAGNOSTIC_TEST

Participants will attend an outpatient clinic, fasted for at least 4 hours for collection of stool.

Oesophageal adenocarcinoma survivors

Health-related Quality of life questionnaires DIAGNOSTIC_TEST

Participants will attend an outpatient clinic and complete validated healthy-related quality-of-life questionnaires.

Oesophageal adenocarcinoma survivors

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Disease free survivors who underwent curative treatment for oesophageal adenocarcinoma

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator
• West Hertfordshire Teaching Hospitals NHS Trust: collaborator
• Barking, Havering and Redbridge University Hospitals NHS Trust: collaborator

Study Sites (3)

Barking, Havering and Redbridge University Hospitals NHS Trust

London, United Kingdom

Location

Imperial College Healthcare NHS Trust

London, United Kingdom

Location

West Hertfordshire NHS Teaching Hospitals

London, United Kingdom

Location

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Breath Tests; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: March 9, 2022
• Primary Completion: October 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

GB (3)