Clinical trial · Observational
Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bacterial Overgrowth | — | UNRESOLVED | — |
| Oesophageal Cancer | Esophageal Neoplasm | PROBABILISTIC | 0.70 |
| Quality of Life | — | UNRESOLVED | — |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sample | Diagnostic Test | — | UNRESOLVED |
| Breath test | Diagnostic Test | — | UNRESOLVED |
| Health-related Quality of life questionnaires | Diagnostic Test | — | UNRESOLVED |
| Saliva sample | Diagnostic Test | — | UNRESOLVED |
| Stool sample | Diagnostic Test | — | UNRESOLVED |
| Urine sample | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Oesophageal adenocarcinoma survivors
- description
- 100 disease free survivors who underwent multimodality treatment for oesophageal adenocarcinoma and are \>1 year post oesophagectomy
- interventionNames
- 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
Primary outcomes (2)
- measure
- Identify microbiome dysbiosis in saliva associated with long-term functional symptoms.
- timeFrame
- 24 months
- description
- Metagenomic sequencing of saliva samples.
- measure
- Identify microbiome dysbiosis in stool associated with long-term functional symptoms.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available