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Assessing the impact of a new fit test in the context of a population based organized screening programme for colorectal cancer

Assessing the impact of a new fit test in the context of a population based organized screening programme for colorectal cancer: a comparative effectiveness trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN20086618
Enrollment
48878
Registered
2016-05-17
Start date
2014-11-06
Completion date
Unknown
Last updated
2018-04-30

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

Conditions

Colorectal cancer Cancer Colorectal cancer

Interventions

During the enrolment period (from 06 November 6th, 2014 to 31 March 2015), all the eligible population were randomly allocated (ratio 1:1) to be screened with two fecal immunochemical test (FIT) syst

Sponsors

Umbria Region: Prevention, veterinary and food safety
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Participation rate, measured at 6 months since the invitation, as the proportion of those performing the test of those invited

Secondary

MeasureTime frame
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 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 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 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 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

Countries

Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 28, 2026