Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors

NCT ID: NCT06302660

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-09

Study Completion Date

2025-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Oesophageal Cancer Quality of Life Bacterial Overgrowth

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Oesophageal adenocarcinoma survivors

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

Breath test

Intervention Type DIAGNOSTIC_TEST

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

Saliva sample

Intervention Type DIAGNOSTIC_TEST

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

Blood sample

Intervention Type DIAGNOSTIC_TEST

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

Urine sample

Intervention Type DIAGNOSTIC_TEST

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

Stool sample

Intervention Type DIAGNOSTIC_TEST

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

Health-related Quality of life questionnaires

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Breath test

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

Intervention Type DIAGNOSTIC_TEST

Saliva sample

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

Intervention Type DIAGNOSTIC_TEST

Blood sample

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

Intervention Type DIAGNOSTIC_TEST

Urine sample

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

Intervention Type DIAGNOSTIC_TEST

Stool sample

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

Intervention Type DIAGNOSTIC_TEST

Health-related Quality of life questionnaires

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Imperial College Healthcare NHS Trust

OTHER

Sponsor Role collaborator

West Hertfordshire Teaching Hospitals NHS Trust

UNKNOWN

Sponsor Role collaborator

Barking, Havering and Redbridge University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Barking, Havering and Redbridge University Hospitals NHS Trust

London, , United Kingdom

Site Status

Imperial College Healthcare NHS Trust

London, , United Kingdom

Site Status

West Hertfordshire NHS Teaching Hospitals

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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22/LO/0169

Identifier Type: -

Identifier Source: org_study_id

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