Back to resultsThe Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration (PERFECT-FIT)
Primary Purpose
Colorectal Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Personalized screening invitation interval
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer
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
Sites / Locations
- ErasmusMC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention arm
Control arm
Arm Description
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.
Participants receive a standard screening invitation interval (2 years).
Outcomes
Primary Outcome Measures
Detection rate of colorectal cancer and advanced adenomas
Number of colorectal cancers and advanced adenomas per screened individual
Secondary Outcome Measures
Acceptability
Number of individuals participating in personalized FIT screening
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05423886
Brief Title
The Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration
Acronym
PERFECT-FIT
Official Title
The Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2022 (Anticipated)
Primary Completion Date
July 2025 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Esther Toes-Zoutendijk
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
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.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
Participants receive a standard screening invitation interval (2 years).
Intervention Type
Other
Intervention Name(s)
Personalized screening invitation interval
Intervention Description
Time to receive the next invitation for fecal immunochemical testing screening, will depend based on individuals risk determined by fecal Hemoglobin concentration
Primary Outcome Measure Information:
Title
Detection rate of colorectal cancer and advanced adenomas
Description
Number of colorectal cancers and advanced adenomas per screened individual
Time Frame
6 months after the last invitation
Secondary Outcome Measure Information:
Title
Acceptability
Description
Number of individuals participating in personalized FIT screening
Time Frame
6 months after the last invitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
56 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Esther Toes-Zoutendijk, PhD
Phone
+31107038454
Email
e.toes-zoutendijk@erasmusmc.nl
First Name & Middle Initial & Last Name or Official Title & Degree
Lucie de Jonge, MSc
Phone
+31107038591
Email
l.dejonge.3@erasmusmc.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iris Lansdorp-Vogelaar, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
ErasmusMC
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Esther Toes-Zoutendijk, PhD
Phone
+31629535367
Email
e.toes-zoutendijk@erasmusmc.nl
First Name & Middle Initial & Last Name & Degree
Lucie de Jonge, MSc
Phone
+31107038591
Email
l.dejonge.3@erasmusmc.nl
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Outcomes of the study will be stored in the national screening information system, owned by a third-party sources. Data cannot be publicly shared.
Learn more about this trial
The Effectiveness of Personalized Colorectal Cancer Screening Based on Fecal Hemoglobin Concentration
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