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

Sponsor

Esther Toes-Zoutendijk (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05423886

Collaborator

(none)

20,000

Enrollment

Location

Arms

Anticipated Duration (Months)

588.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer	Other: Personalized screening invitation interval	N/A

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:

Evaluate the superiority of risk-based FIT screening in a randomized controlled study embedded in a running national screening program;
Evaluate the feasibility and acceptability of risk-based FIT screening in a national screening program;
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 Design

Study Type:

Interventional

Anticipated Enrollment :

20000 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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).

Masking:

None (Open Label)

Primary Purpose:

Screening

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Jul 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Intervention arm 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.	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
No Intervention: Control arm Participants receive a standard screening invitation interval (2 years).

Arm

Intervention/Treatment

Experimental: Intervention arm

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.

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

No Intervention: Control arm

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

Outcome Measures

Primary Outcome Measures

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

Acceptability [6 months after the last invitation]
Number of individuals participating in personalized FIT screening

Eligibility Criteria

Criteria

Ages Eligible for Study:

56 Years to 71 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	ErasmusMC	Rotterdam		Netherlands	3015 GD

Sponsors and Collaborators

Esther Toes-Zoutendijk

Investigators

Principal Investigator: Iris Lansdorp-Vogelaar, PhD, Erasmus Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Esther Toes-Zoutendijk, Dr., Erasmus Medical Center

ClinicalTrials.gov Identifier:

NCT05423886

Other Study ID Numbers:

WO 19-44

First Posted:

Jun 21, 2022

Last Update Posted:

Jun 21, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Colorectal Neoplasms

Study Results

No Results Posted as of Jun 21, 2022