NCT02698462

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Status
completed

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

February 29, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
29 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
Last Updated

March 17, 2025

Status Verified

March 1, 2025

Enrollment Period

2.1 years

First QC Date

February 29, 2016

Last Update Submit

March 13, 2025

Conditions

Colorectal Neoplasms

Keywords

Advanced neoplasiaColorectal cancerPopulation screeningFamily history

Outcome Measures

Primary Outcomes (1)

  • Diagnostic yield

    number of participants in whom advanced neoplasia is detected relative to the number of invitees

    1.5 years

Secondary Outcomes (2)

  • Participation rate

    1.5 years

  • Positive predictive value

    1.5 years

Other Outcomes (13)

  • The number of invitees with a familial CRC syndrome

    1.5 years

  • FIT result of participants with a familial CRC syndrome

    1.5 years

  • The number of family members of participants with a familial CRC syndrome who receive an advice for genetic testing and/or surveillance colonoscopies

    1.5 years

  • +10 more other outcomes

Study Arms (1)

FIT and Questionnaire

OTHER

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.

Other: Family history questionnaire

Interventions

Family history questionnaireOTHER

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.

FIT and Questionnaire

Eligibility Criteria

Age59 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Roos 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: 32307443DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Evelien Dekker, MD PhD

    Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor MD

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 3, 2016

Study Start

April 1, 2016

Primary Completion

May 15, 2018

Study Completion

May 15, 2018

Last Updated

March 17, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share