NCT02715141

Molecular Stool Testing for Colorectal Cancer Surveillance

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 3,966 (actual)
• Sponsor: The Netherlands Cancer Institute · Academic / Other
• Sex: All
• Age: 50 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Collection of stool sample	Collection of stool sample prior to the scheduled surveillance colonoscopy.

Timeline

• Start date: 2015-10-01
• Primary completion: 2020-12-01
• Completion: 2020-12-15
• First posted: 2016-03-22
• Last updated: 2022-01-25

Locations

1 site across 1 country: Netherlands