The Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration (PERFECT-FIT)

Esther Toes-Zoutendijk

Status: Not yet enrolling

Conditions: Colorectal Cancer

Treatments: Other: Personalized screening invitation interval

Study type: Interventional

Funder types: Other

Identifiers

NCT05423886

WO 19-44

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 56 to 71 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20,000 participants in 2 patient groups

Intervention arm

Experimental group

Description:

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.

Treatment:

Other: Personalized screening invitation interval

Control arm

No Intervention group

Description:

Participants receive a standard screening invitation interval (2 years).