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

Colorectal Cancer Clinical Trial

— PERFECT-FIT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05423886
• Other study ID #: WO 19-44
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: July 2025

Study information

• Verified date: June 2022
• Source: Erasmus Medical Center
• Contact: Esther Toes-Zoutendijk, PhD
• Phone: +31107038454
• Email: e.toes-zoutendijk[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20000
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 56 Years to 71 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Personalized 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

Locations

Country	Name	City	State
Netherlands	ErasmusMC	Rotterdam

Sponsors (1)

Lead Sponsor	Collaborator
Esther Toes-Zoutendijk

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Acceptability	Number of individuals participating in personalized FIT screening	6 months after the last invitation