NCT06302660进行中（未招募）不适用
Profiling Microbiome Associated Metabolic Pathways in Oesophageal Cancer Survivors
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Identify microbiome dysbiosis in stool associated with long-term functional symptoms.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Identify microbiome dysbiosis in stool associated with long-term functional symptoms.
时间窗: 24 months
Metagenomic sequencing of stool samples.
Identify microbiome dysbiosis in saliva associated with long-term functional symptoms.
时间窗: 24 months
Metagenomic sequencing of saliva samples.
次要结局
- 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)
研究者
研究点 (3)
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