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OpenTrials
Completed

NCT Number: NCT04049357

Care for Colon 2015

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.

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Key information

Conditions

Colorectal Cancer Adenoma Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Rectal Diseases

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital, Svendborg Sygehus

Svendborg, 5700, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participation in the Danish colorectal screening program

Exclusion criteria

  • None

Treatment and study plan

Camera Capsule Endoscopy/ PillCam

Device

Camera Capsule Endoscopy in screening

Primary outcomes

  1. CCE detection rate of polyps compared to OC

    Time frame: Within 30 days

    The investigators aim to conduct a large scale randomized trial to investigate the implementation of CCE as part of the Danish screening protocol.

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

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

Acronym: CFC2015

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Aug 8, 2019
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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