Molecular Stool Testing for Colorectal Cancer Surveillance
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      BACKGROUND: Since January 2014 the Dutch screening programme for colorectal carcinoma (CRC)
      has been implemented. Screening will increase the demand for surveillance. However, 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 patient burden and high costs. Therefore, there is need for new surveillance
      strategies. Stool-based molecular testing (Cologuard®) or Faecal Immunochemical Testing (FIT)
      may serve as an alternative for colonoscopy surveillance.

      OBJECTIVES:

        1. 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.

        2. To model various strategies of stool-based molecular surveillance to inform health
           policy decisions.

      MATERIALS AND METHODS: In this prospective observational cross-sectional cohort study,
      individuals aged 50-75 years that are scheduled for surveillance colonoscopy will be invited
      to participate. They are asked to collect a whole-stool sample prior to the surveillance
      colonoscopy. The sample will be used to test for the presence of molecular stool markers. The
      results of the molecular stool test and FIT will be compared to the colonoscopy findings.

      EXPECTED RESULTS: Frequent surveillance using stool-based molecular testing is more
      cost-effective than the current colonoscopy-based surveillance.
    

Intervention name(s): Collection of stool sample
Intervention type(s): Behavioral
Intervention description(s): Collection of stool sample prior to the scheduled surveillance colonoscopy.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The intended population of this study consists all subjects in the participating centres
        that are elected for colonoscopy surveillance.
      
Biospecimen description: 
      Stool samples will be collected. The stool samples will be used to test for the presence of
      molecular stool markers.
    
Keywords: surveillance, molecular stool testing