Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors (MAPLES)

Imperial College London

Status: Active, not recruiting

Conditions: Oesophageal Cancer; Quality of Life; Bacterial Overgrowth

Treatments: Diagnostic Test: Health-related Quality of life questionnaires; Diagnostic Test: Saliva sample; Diagnostic Test: Blood sample; Diagnostic Test: Breath test; Diagnostic Test: Stool sample; Diagnostic Test: Urine sample

Study type: Observational

Funder types: Other

Identifiers

NCT06302660

22/LO/0169

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Oesophageal adenocarcinoma survivors

Description:

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

Treatment:

Diagnostic Test: Urine sample

Diagnostic Test: Stool sample

Diagnostic Test: Breath test

Diagnostic Test: Blood sample

Diagnostic Test: Saliva sample

Diagnostic Test: Health-related Quality of life questionnaires