Molecular Stool Testing for Colorectal Cancer Surveillance

Rationale: Since January 2014 the Dutch screening programme for bowel cancer has been implemented. Screening will increase the demand for surveillance. Although patients in whom adenomas have been removed are at increased risk of progressing to cancer, solid evidence on the reduction of death from CRC through the current colonoscopy-based surveillance is lacking. Furthermore, colonoscopy-based surveillance leads to high logistic demands, high individual burden and high costs. Therefore, there is need for new surveillance strategies. Stool-based molecular testing (Cologuard, consisting of a stool DNA test and an immunochemical assay for human hemoglobin) or Faecal Immunochemical Testing (FIT) may serve as an alternative for colonoscopy surveillance.
The aim of this study is to compare the accuracy of an established molecular stool test (Cologuard) and FIT to colonoscopy for detection of advanced adenomas or CRC (advanced neoplasia) in a surveillance population. These outcomes will be used to model various strategies of stool-based molecular surveillance to inform health policy decisions.

研究依据：自2014年1月起，荷兰正式启动结直肠癌筛查项目。筛查工作将提升对随访监测的临床需求。尽管已切除腺瘤的患者进展为癌症的风险显著升高，但目前尚无确凿证据表明，当前基于结肠镜检查的随访监测可降低结直肠癌（CRC）相关死亡风险。此外，基于结肠镜检查的随访监测存在较高的后勤保障需求、个体负担与医疗成本。因此，亟需开发新型随访监测策略。基于粪便的分子检测（如Cologuard，由粪便DNA检测与针对人血红蛋白的免疫化学检测组成）或粪便免疫化学检测（FIT），或可作为结肠镜随访监测的替代方案。

本研究旨在对比经验证的粪便分子检测（Cologuard）、FIT与结肠镜检查在随访人群中检测进展性腺瘤或结直肠癌（CRC，即进展性肿瘤）的准确度。上述研究结果将用于构建各类基于粪便的分子监测策略模型，为卫生政策制定提供决策依据。