MedTrace Logo

Adding Family History of Colorectal Cancer to the Dutch FIT-based Screening Program

NCT02698462 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6000

Last updated 2025-03-17

No results posted yet for this study

Summary

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

  • Colorectal Neoplasms

Interventions

OTHER

Family history questionnaire

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 (cut-off value 275 ng/ml) and/or a positive family history and a diagnosis of familial CRC by a clinical geneticist will be referred for colonoscopy.

Sponsors & Collaborators

  • Dutch Digestive Diseases Foundation

    collaborator OTHER

  • Prof. Evelien Dekker, MD, PhD

    lead OTHER

Principal Investigators

  • Evelien Dekker, MD PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
59 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2018-05-15
Completion
2018-05-15

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02698462 on ClinicalTrials.gov