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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05423886
Acronym
PERFECT-FIT
Enrollment
20000
Registered
2022-06-21
Start date
2022-09-30
Completion date
2025-07-31
Last updated
2022-06-21

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

Conditions

Colorectal Cancer

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.

Interventions

OTHERPersonalized screening invitation interval

Time to receive the next invitation for fecal immunochemical testing screening, will depend based on individuals risk determined by fecal Hemoglobin concentration

Sponsors

Esther Toes-Zoutendijk
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

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).

Eligibility

Sex/Gender
ALL
Age
56 Years to 71 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Detection rate of colorectal cancer and advanced adenomas6 months after the last invitationNumber of colorectal cancers and advanced adenomas per screened individual

Secondary

MeasureTime frameDescription
Acceptability6 months after the last invitationNumber of individuals participating in personalized FIT screening

Countries

Netherlands

Contacts

Primary ContactEsther Toes-Zoutendijk, PhD
e.toes-zoutendijk@erasmusmc.nl+31107038454
Backup ContactLucie de Jonge, MSc
l.dejonge.3@erasmusmc.nl+31107038591

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 10, 2026