Population screening for colorectal cancer by colonoscopy or CT-colonography in the Netherlands.

RCT: Population screening for colorectal cancer by colonoscopy or CT-colonography in the Netherlands.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24258

Enrollment

7500

Registered

2009-05-25

Start date

2009-06-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal cancer, adenomatous polyps, screening, colonoscopy, CT-colonography

Interventions

For this study, 7500 persons will be invited and randomized (1:1:1) in three different arms: 1. CT-colonography (2500 individuals)

2. Colonoscopy and preliminary interview by phone (2500 individuals)

3. Colonoscopy and preliminary interview at outpatient clinic (2500 individuals). Furthermore, an extra number of 10.000 persons will be randomized for the NORDICC trial (this trial will be registere

Eligibility

Inclusion criteria

Inclusion criteria: 1. Asymptomatic individuals between 50 and 74 years of age; 2. Individuals living in pre-selected postal areas in Amsterdam and Rijnmond region.

Exclusion criteria

Exclusion criteria: 1. Participants in previous CRC population screening trials; 2. Complete colonoscopy performed within the last 5 years; 3. Personal history of colonic adenomas or colorectal cancer; 4. Longstanding IBD; 5. Severe or terminal disease (life-expectancy < 5 years); 6. Inability or refusal to provide informed consent.

Design outcomes

Primary

Measure	Time frame
Evaluation of the participation rate of a population-based screening program by colonoscopy or CT-colonography in the Netherlands.	—

Secondary

Measure	Time frame
1. Evaluation of the feasibility of CRC screening by direct colonoscopy and CT-colonography in the Netherlands; 2. Evaluation of the quality (including complications) of direct colonoscopy and CT-colonography screening for CRC; 3. Evaluation of the yield of CRC screening by colonoscopy and CT-colonography; 4. Evaluation of the expected burden of colonoscopy and CT-colonography; 5. Evaluation of the perceived burden of colonoscopy and CT-colonography; 6. Evaluation of the reasons for participation and non-participation in a population based CRC screening program; 7. Evaluation of the satisfaction and safety of preliminary interview by phone or at the outpatient clinic; 8. Evaluation of the level of informed choice in the decision-making process in a population-based CRC screening programme; 9. Participants time-investment analyses of CRC screening by colonoscopy or CT-colonography; 10. Cost-effectiveness analysis of CRC screening by direct colonoscopy and CT-colonography.	—

Measure

Time frame

1. Evaluation of the feasibility of CRC screening by direct colonoscopy and CT-colonography in the Netherlands; 2. Evaluation of the quality (including complications) of direct colonoscopy and CT-colonography screening for CRC; 3. Evaluation of the yield of CRC screening by colonoscopy and CT-colonography; 4. Evaluation of the expected burden of colonoscopy and CT-colonography; 5. Evaluation of the perceived burden of colonoscopy and CT-colonography; 6. Evaluation of the reasons for participation and non-participation in a population based CRC screening program; 7. Evaluation of the satisfaction and safety of preliminary interview by phone or at the outpatient clinic; 8. Evaluation of the level of informed choice in the decision-making process in a population-based CRC screening programme; 9. Participants time-investment analyses of CRC screening by colonoscopy or CT-colonography; 10. Cost-effectiveness analysis of CRC screening by direct colonoscopy and CT-colonography.

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Contacts

Public ContactEvelien Dekker

Academic Medical Center (AMC) Department of Gastroenterology and Hepatology P.O. Box 22660

e.dekker@amc.uva.nl+31 (0)20 5664702

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)