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

Not Applicable

Not yet recruiting

• Conditions: Colorectal Cancer
• Interventions: Other: Personalized screening invitation interval

• Registration Number: NCT05423886
• Lead Sponsor: Esther Toes-Zoutendijk

Brief Summary

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

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:

1. Evaluate the superiority of risk-based FIT screening in a randomized controlled study embedded in a running national screening program;

2. Evaluate the feasibility and acceptability of risk-based FIT screening in a national screening program;

3. 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.

Study Timeline

• Status Verified: 2022-06
• Study First Submitted: 2022-06-14
• Study First Submitted QC: 2022-06-14
• Last Update Submitted: 2022-06-14
• Study First Posted: 2022-06-21
• Last Update Posted: 2022-06-21
• Study Start: 2022-09
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20000

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention arm	Personalized screening invitation interval	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.

Primary Outcome Measures

Name	Time	Method
Detection rate of colorectal cancer and advanced adenomas	6 months after the last invitation	Number of colorectal cancers and advanced adenomas per screened individual

Secondary Outcome Measures

Name	Time	Method
Acceptability	6 months after the last invitation	Number of individuals participating in personalized FIT screening

Trial Locations

Locations (1)

ErasmusMC; 🇳🇱 Rotterdam, Netherlands