The Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration
PERFECT-FIT
1 other identifier
interventional
20,000
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable colorectal-cancer
Started Sep 2022
Typical duration for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2022
CompletedFirst Posted
Study publicly available on registry
June 21, 2022
CompletedStudy Start
First participant enrolled
September 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2025
CompletedJune 21, 2022
June 1, 2022
2.8 years
June 14, 2022
June 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Acceptability
6 months after the last invitation
Study Arms (2)
Intervention arm
EXPERIMENTALParticipants 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.
Control arm
NO INTERVENTIONParticipants receive a standard screening invitation interval (2 years).
Interventions
Time to receive the next invitation for fecal immunochemical testing screening, will depend based on individuals risk determined by fecal Hemoglobin concentration
Eligibility Criteria
You may qualify if:
- Previous negative FIT (below the cut-off of 47 microgram per gram feces)
You may not qualify if:
- Previously tested with FIT cut-off of 15 microgram per gram feces
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ErasmusMC
Rotterdam, 3015 GD, Netherlands
Related Publications (1)
Breekveldt ECH, Toes-Zoutendijk E, de Jonge L, Spaander MCW, Dekker E, van Kemenade FJ, van Vuuren AJ, Ramakers CRB, Nagtegaal ID, van Leerdam ME, Lansdorp-Vogelaar I. Personalized colorectal cancer screening: study protocol of a mixed-methods study on the effectiveness of tailored intervals based on prior f-Hb concentration in a fit-based colorectal cancer screening program (PERFECT-FIT). BMC Gastroenterol. 2023 Feb 22;23(1):45. doi: 10.1186/s12876-023-02670-1.
PMID: 36814185DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Iris Lansdorp-Vogelaar, PhD
Erasmus Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr.
Study Record Dates
First Submitted
June 14, 2022
First Posted
June 21, 2022
Study Start
September 1, 2022
Primary Completion
July 1, 2025
Study Completion
July 1, 2025
Last Updated
June 21, 2022
Record last verified: 2022-06
Data Sharing
- IPD Sharing
- Will not share
Outcomes of the study will be stored in the national screening information system, owned by a third-party sources. Data cannot be publicly shared.