The LABS Study: Longitudinal Assessment of Biomarkers After Oesophagogastric Cancer Surgery (BIORESOURCE 2: Longitudinal)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Salivary microbial biomarkers to predict treatment response and long-term prognosis
研究概览
简要总结
Oesophagogastric cancer (cancer of the gullet and stomach) is the fifth most common cancer in England and Wales with 16,000 new cases diagnosed every year. Survival rates are poor with only 15% surviving beyond 5 years. There is also increasing research to understand the cancer biology and factors allowing cancers to progress. It is likely there is a relationship between the cancer-specific microbiome, cells related to inflammation, which promotes cancer progression. The BIORESOURCE 1 study has established a comprehensive resource of matched samples from patients with oesophageal and gastric cancer. This longitudinal study aims to obtain further matched biosamples in the follow-up period after cancer surgery to find biomarkers that may predict treatment response, recurrence and/or long term prognosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Aged 18-90 years at the time of initial recruitment
- •Gastric/oesophageal adenocarcinoma cohort (biopsy proven adenocarcinoma) recruited into BIORESOURCE 1
排除标准
- •Oesophageal squamous cell carcinoma
- •Previous oesophageal and gastric resection
- •History of another cancer within five years. If a new other cancer type is diagnosed within the sampling time frame, no further samples will be taken.
- •Participants with co-morbidities preventing breath collection
- •Unable or unwilling to provide informed written consent
- •Pregnant women
结局指标
主要结局
Salivary microbial biomarkers to predict treatment response and long-term prognosis
时间窗: 48 months
Changes in the presence and/or abundance of bacteria over a 2 year period, measured primarily within saliva.
次要结局
- Breath volatile organic compound profile alterations of oesophagogastric cancer pre- and post- treatment(48 months)
- Quality of life measure up to 2 years following cancer surgery using validated questionnaires(48 months)