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Care for Colon 2015

Colon Capsule Endoscopy in Bowel Cancer Screening. A Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04049357
Acronym
CFC2015
Enrollment
2031
Registered
2019-08-08
Start date
2020-08-03
Completion date
2024-10-01
Last updated
2025-10-02

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

Conditions

Adenoma, Colorectal Cancer

Keywords

Camera Capsule Endoscopy, Colorectal cancer screening, Optical colonoscopy, Colorectal cancer

Brief summary

The investigatior believe that implementing camera capsule endoscopy as a filter test to colonoscopy will increase screening participation, increase the number of individuals with detected intermediate- high risk adenomas or cancer, reduce the colonoscopy demand and reduce the number of complications.

Detailed description

The Danish national colorectal cancer screening program includes all citizens aged 50-74 years, who are invited biennially to a fecal test for invisible blood in the stool. If the test is positive the citizen is invited for a colonoscopy. 90% of the test-positive undergo colonoscopy. The detected cancers are at a significant earlier stage and survival from screening detected cancer is higher. It is also expected that cancer incidence will drop due to removal of the advanced adenomas before they develop into cancer. Although initial results are positive, there is room for improvement. Additionally there are rare but serious complications to colonoscopy in the form of bleeding or bowel perforation. Through four years the investigators have tested the colon capsule endoscopy method, and find that the investigation is associated with significantly less discomfort and that the diagnostic ability to find polyps \> 1 cm is better than colonoscopy.

Interventions

DEVICECamera Capsule Endoscopy/ PillCam

Camera Capsule Endoscopy in screening

Sponsors

Odense University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

The investigators will include 124.214 consecutive citizens from the Region of Southern Denmark when they are invited for screening. The participants will be randomized into two groups using an automated randomization tool provided by Odense Patient data Explorative Network (OPEN). The randomization will be based on Zelen's pre-randomization principle and will take place prior to citizens receiving the invitation. The individuals are randomized into 62.107 people allocated in the intervention group and 62.107 allocated in the control group.

Eligibility

Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
No

Inclusion criteria

* Participation in the Danish colorectal screening program

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
CCE detection rate of polyps compared to OCWithin 30 daysThe investigators aim to conduct a large scale randomized trial to investigate the implementation of CCE as part of the Danish screening protocol.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026