MOlecular stool testing for Colorectal CAncer Surveillance

MOlecular stool testing for Colorectal CAncer Surveillance - MOCCAS

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50418

Enrollment

4000

Registered

2015-07-09

Start date

2015-11-03

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colorectal carcinoma colorectal neoplasia

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Subjects in the age group 50-75 years. - Subjects with an indication for surveillance colonoscopy according to the previous guideline (*Follow up after polypectomy*, 2002; summarized in 2008) or current (*Colonoscopy Surveillance*, 2013) guideline, i.e. subjects with a history of CRC or polypectomy, as well as subjects under surveillance for familial colorectal carcinoma (FCC). - Subjects who have sufficient comprehension of the Dutch language. - Subjects who have given their informed consent.

Exclusion criteria

Exclusion criteria: - Subjects with inflammatory bowel disease (IBD) - Subjects with Lynch syndrome, familial adenomatous polyposis (FAP), attenuated FAP (AFAP), MUTYH associated polyposis (MAP) and serrated polyposis syndrome (SPS) - Subjects with a previous colonoscopy

Design outcomes

Primary

Measure	Time frame
1. The accuracy (sensitivity, specificity, PPV and NPV) of the molecular stool test (Cologuard®) and FIT compared to colonoscopy in the detection of advanced neoplasia compared in a surveillance population. 2. Health outcomes and cost-effectivess of multiple surveillance strategies based on accuracies from endpoint 1.	—

Secondary

Measure	Time frame
- The accuracy of the molecular stool test (Cologuard®) and FIT in relation to patient characteristics ((i.e. age, gender, family history, BMI and smoking); - The presence of the molecular markers (included in the molecular stool test) in the resected polyps; - The correlation between the presence of the molecular markers and the result of the molecular stool test. - The identification of low- and high risk adenomas based on previously identified progression biomarkers in all the post-polypectomy tissue samples; - The impact of molecularly defined high-risk adenomas on the obtained sensitivity data of the molecular stool test (Cologuard®) and FIT; - The impact of the integration of molecularly defined high-risk adenomas on the health outcomes and cost-effectiveness of the multiple surveillance strategies. - The additional value of risk assessment through a questionnaire (addressing gender, age, BMI20,21, family history22,23, physical activity, nutritional habits and smoking) on the accuracy of the molecular stool test (Cologuard®) and FIT;	—

Measure

Time frame

- The accuracy of the molecular stool test (Cologuard®) and FIT in relation to patient characteristics ((i.e. age, gender, family history, BMI and smoking); - The presence of the molecular markers (included in the molecular stool test) in the resected polyps; - The correlation between the presence of the molecular markers and the result of the molecular stool test. - The identification of low- and high risk adenomas based on previously identified progression biomarkers in all the post-polypectomy tissue samples; - The impact of molecularly defined high-risk adenoma*s on the obtained sensitivity data of the molecular stool test (Cologuard®) and FIT; - The impact of the integration of molecularly defined high-risk adenoma*s on the health outcomes and cost-effectiveness of the multiple surveillance strategies. - The additional value of risk assessment through a questionnaire (addressing gender, age, BMI20,21, family history22,23, physical activity, nutritional habits and smoking) on the accuracy of the molecular stool test (Cologuard®) and FIT;

—

Countries

Netherlands

Outcome results