Assessing the impact of a new fit test in the context of a population based organized screening programme for colorectal cancer
Completed
- Conditions
- Colorectal cancerCancer
- Registration Number
- ISRCTN20086618
- Lead Sponsor
- mbria Region: Prevention, veterinary and food safety
- Brief Summary
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/27974550
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 48878
Inclusion Criteria
1. Men and women
2. Age ranged 50-74 years
3. Resident in Umbria Region
4. Without personal history of colorectal cancer
Exclusion Criteria
1. Personal history of colorectal cancer
2. Participants undergone tests for fecal blood within 2 years
3. Participants undergone sigmoidoscopy or colonoscopy within 5 years
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Participation rate, measured at 6 months since the invitation, as the proportion of those performing the test of those invited
- Secondary Outcome Measures
Name Time Method 1. Proportion of inadequate tests: measured at the end of the study, as the proportion of samples with inadequate material for the analysis. Laboratory assessment <br>2. Positivity rate: measured at the end of the study, as the proportion of samples with Hb level above the stipyulated cut-off value (100 ng/ml buffer) over the total number of adequate tests. Laboratory assessment <br>3. Positive predictive value (PPV): mesasured at the end of the study, as the proportion of subjects detected with a CRC or advanced adenoma over those ubdergoring colonscopy assessment<br>4. Detection rate (DR) for advanced adenoma and CRC: mesasured at the end of the study, as the proportion of subjects detected with a CRC or advanced adenoma over those who have perfromed the FIT test<br>5. Number needed to scope (NNScope) to detect one advanced neoplasm (AN: advanced adenoma + CRC):mesasured at the end of the study, as 1/PPV