The Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration

Study Overview
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Brief Summary
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We aim to improve the yield and effectiveness of the Dutch colorectal cancer screening program by using a personalized screening strategy based on fecal Hemoglobin concentration in previous screening round for participants with a negative fecal immunochemical test (FIT).

Detailed Description
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A fecal Hemoglobin concentration just below the cut-off of the fecal immunochemical test (FIT) is associated with a higher risk for the detection of colorectal cancer of advanced adenomas at consecutive screenings. Individuals with these higher fecal Hemoglobin concentrations may benefit from shorter screenings interval, whereas individuals without any fecal Hemoglobin concentrations could benefit from longer screening intervals. A randomized controlled trial will be conducted within the national CRC screening program among individuals with a negative FIT in the previous screening round. Individuals in the intervention arm will receive an invitation after 1, 2, or 3 years depending on their fecal Hemoglobin concentration in the previous round, whereas individuals in the control arm will receive an invitation after 2 years according to current practice. The overall aim of this study is to improve the balance between harms and benefits of CRC screening, by using a personalized approach based on fecal Hemoglobin concentration at previous screening. More specifically, this study has three goals: Evaluate the superiority of risk-based FIT screening in a randomized controlled study embedded in a running national screening program; Evaluate the feasibility and acceptability of risk-based FIT screening in a national screening program; Estimate the long-term effect of personalized screening versus uniform screening. To achieve these goals a randomized controlled trial, focus groups and microsimulation modelling will be conducted.

Official Title
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The Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Other: Personalized screening invitation interval


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previous negative FIT (below the cut-off of 47 microgram per gram feces) Exclusion Criteria: Previously tested with FIT cut-off of 15 microgram per gram feces

Ages Eligible for Study
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Minimum Age: 56 Years
Maximum Age: 71 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The intervention arm receives their screening invitation within 1,2 or 3 years, depending on their previous fecal Hemoglobin concentration. The control arm receives their screening invitation in 2 years (current practice).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention arm<br>Participants receive a personalized screening invitation interval (1,2 or 3 years) based on their fecal Hemoglobin concentration of the negative fecal immunochemical test in previous round. | Other: Personalized screening invitation interval<br>* Time to receive the next invitation for fecal immunochemical testing screening, will depend based on individuals risk determined by fecal Hemoglobin concentration<br>|
| No Intervention: Control arm<br>Participants receive a standard screening invitation interval (2 years). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection rate of colorectal cancer and advanced adenomas | Number of colorectal cancers and advanced adenomas per screened individual | 6 months after the last invitation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability | Number of individuals participating in personalized FIT screening | 6 months after the last invitation |