Clinical trial NCT05423886: The Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration
Official title: The Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2022-06-21
Enrollment: 20000
Sex: ALL
Minimum age (years): 56
Maximum age (years): 71
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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).
Primary purpose: SCREENING

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detection rate of colorectal cancer and advanced adenomas
timeFrame: 6 months after the last invitation
Secondary outcomes:
measure: Acceptability
timeFrame: 6 months after the last invitation
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: ErasmusMC
Study officials:
affiliation: Erasmus Medical Center
name: Iris Lansdorp-Vogelaar, PhD
role: PRINCIPAL_INVESTIGATOR
References: