Care for Colon 2015 (CFC2015)
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|ClinicalTrials.gov Identifier: NCT04049357|
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : September 16, 2021
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer Adenoma||Device: Camera Capsule Endoscopy/ PillCam||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2015 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|Official Title:||Colon Capsule Endoscopy in Bowel Cancer Screening. A Randomized Controlled Trial|
|Actual Study Start Date :||April 1, 2020|
|Estimated Primary Completion Date :||October 1, 2022|
|Estimated Study Completion Date :||October 1, 2024|
Experimental: The intervention group
If the FIT test is returned and positive the individual can choose either Camera Capsule Endoscopy (CCE) or Optical colonoscopy (OC) as the primary bowel investigation. If OC is chosen, it is performed as standard and the participant outcomes remains analyzed in the intervention group as intention to treat.
If CCE is chosen an out-clinic CCE will be done at one of four regional sites. Overall and segmental bowel preparation grade (Leighton-Rex 1-4) and all pathological findings are reported. If the anal verge is identified without video blackout in the colon the transit is considered complete. Any incomplete CCE investigation will be followed by standard optical endoscopy to the extent needed to investigate the proportion of the colon not visualized by the capsule and remove any detected polyps. If the CCE is complete with complete transit and adequate preparation, individuals with more than two polyps or one polyp over 9 mm will be referred for colonoscopy.
Device: Camera Capsule Endoscopy/ PillCam
Camera Capsule Endoscopy in screening
No Intervention: The control group
The control group will be invited to screening as usual. The intervention group will be informed that if the fecal test is returned and positive they can either choose to have an initial colon capsule endoscopy, and only colonoscopy if significant findings are made or an initial colonoscopy as usual.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04049357
|Contact: Gunnar Baatrup, Professor||0045 20575154||Gunnar.Baatrup@rsyd.dk|
|Contact: Thomas Bjørsum-Meyer, PhD||0045 27896080||Thomas.Bjoersum-Meyer@rsyd.dk|
|Odense University Hospital, Svendborg Sygehus||Recruiting|
|Svendborg, Denmark, 5700|
|Contact: Morten K Larsen, PhD email@example.com|