Combining Risk Factors and Faecal Immunochemical Testing in Colorectal Cancer Screening: a Randomized Controlled Trial
Colorectal Cancer, Colorectal Carcinoma, Colorectal Neoplasms

About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring Colorectal Cancer, Screening, Model, Faecal Immunochemic Test, FIT, Occult Blood, Risk Factors, Logistic Regression, Advanced Neoplasia, Advanced Adenoma
Eligibility Criteria
Inclusion Criteria:
In order to be eligible to participate in this study, a screening invitee must meet the following criteria:
- The screening invitee must be at least 55 years old, and no older than 75 years old, at the day of invitation by the Foundation of Population Screening Mid-West
- The screening invitee must be eligible for participation in the second round of the Dutch CRC Population Screening Programme
- The screening invitee must return a signed informed consent form
Exclusion Criteria:
A potential screening invitee who meets any of the following criteria will be excluded from participation in this study:
- if he or she receives active treatment for CRC and/or AN, including palliative care.
- if he or she fails to return a sample that is adequate for FIT testing.
Sites / Locations
- Amsterdam UMC, locatie Academisch Medisch Centrum
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Intervention group
Control group
This group will be screened with the risk-based model. The input of the model will be gathered with the FIT, a validated questionnaire, and from data of the Dutch general population registry. The threshold of the model will be set at a calculated risk of 0.10. To comply with ethical guidelines, all participants in this group with a FIT result of >=15 mcg Hb/g faeces and a calculated risk of <0.10 will also be offered a colonoscopy.
This group will be screened with the FIT. The threshold of the FIT will be set at >= 15 mcg Hb/g faeces.