Clinical trial · Interventional
Adding Family History of Colorectal Cancer to the Dutch FIT-based Screening Program
Adding Family History of Colorectal Cancer to the FIT-based Screening Program in a Dutch Colorectal Cancer Population Sample
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to identify more persons with advanced neoplasia in the current national CRC screening, by adding data on family history of CRC (using a validated online questionnaire) to FIT. In addition, the aim is to identify those persons and their family members who should not be participating in a FIT based screening but receive surveillance colonoscopies instead, because of a familial CRC syndrome. It is aimed to increase detection without affecting participation, thereby increasing the yield of screening.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Family history questionnaire | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- FIT and Questionnaire
- description
- Six thousand persons eligible for the national CRC screening program will be selected. They will be selected from four areas that are considered representative of the Netherlands. All invitees receive an invitation to complete a FIT (FOB-Gold) and a validated, online family history questionnaire. Answers from the questionnaire are compared with the Dutch criteria for referral for genetic testing and/or surveillance colonoscopies for persons at a potential familial risk for CRC. Invitees are invited to perform both tests, but if they only perform one this will be assessed. Participants with a positive FIT and/or a positive family history and a diagnosis of familial CRC by a clinical geneticist will be referred for colonoscopy.
- interventionNames
- Other: Family history questionnaire
Primary outcomes (1)
- measure
- Diagnostic yield
- timeFrame
- 1.5 years
- description
- number of participants in whom advanced neoplasia is detected relative to the number of invitees
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 59 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: Six thousand persons eligible for the national CRC screening program, consisting of persons from the birth years 1941, 1945, 1953, 1955 and 1957 will be selected. These persons will be selected from four areas in North-Holland that are considered representative of the Netherlands regarding ethnical distribution and socioeconomic status: Aalsmeer, De Ronden Venen, Ouder-Amstel, Stichtse Vecht. These areas had an average participation-rate in 2014 that was comparable to the national participation rate (68.2%; a range from 65% to 75% is allowed). The distribution of age groups and gender will be comparable to the national screening distribution in 2016. Those who have been invited for a previous screening round in 2014 or for previous pilot-screening rounds will not be selected. In order to be eligible for participation, a subject must have been selected for participation in the national FIT-screening program in 2016. Exclusion Criteria: No specific exclusion criteria apply for participation in Family Matters, meaning that all invitees will receive a FIT as well as the questionnaire.
References
Publications (1)
- DERIVEDRoos VH, Kallenberg FGJ, van der Vlugt M, Bongers EJC, Aalfs CM, Bossuyt PMM, Dekker E. Addition of an online, validated family history questionnaire to the Dutch FIT-based screening programme did not improve its diagnostic yield. Br J Cancer. 2020 Jun;122(12):1865-1871. doi: 10.1038/s41416-020-0832-8. Epub 2020 Apr 20. PMID 32307443