Back to resultsCare for Colon 2015 (CFC2015)
Primary Purpose
Colorectal Cancer, Adenoma
Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Camera Capsule Endoscopy/ PillCam
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Cancer focused on measuring Camera Capsule Endoscopy, Colorectal cancer screening, Optical colonoscopy, Colorectal cancer
Eligibility Criteria
Inclusion Criteria:
- Participation in the Danish colorectal screening program
Exclusion Criteria:
- None
Sites / Locations
- Odense University Hospital, Svendborg SygehusRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
The intervention group
The control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
CCE detection rate of polyps compared to OC
The investigators aim to conduct a large scale randomized trial to investigate the implementation of CCE as part of the Danish screening protocol.
Secondary Outcome Measures
Full Information
NCT ID
NCT04049357
First Posted
August 5, 2019
Last Updated
September 8, 2021
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04049357
Brief Title
Care for Colon 2015
Acronym
CFC2015
Official Title
Colon Capsule Endoscopy in Bowel Cancer Screening. A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Adenoma
Keywords
Camera Capsule Endoscopy, Colorectal cancer screening, Optical colonoscopy, Colorectal cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
2015 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
The control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Camera Capsule Endoscopy/ PillCam
Intervention Description
Camera Capsule Endoscopy in screening
Primary Outcome Measure Information:
Title
CCE detection rate of polyps compared to OC
Description
The investigators aim to conduct a large scale randomized trial to investigate the implementation of CCE as part of the Danish screening protocol.
Time Frame
Within 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participation in the Danish colorectal screening program
Exclusion Criteria:
None
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gunnar Baatrup, Professor
Phone
0045 20575154
Email
Gunnar.Baatrup@rsyd.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas Bjørsum-Meyer, PhD
Phone
0045 27896080
Email
Thomas.Bjoersum-Meyer@rsyd.dk
Facility Information:
Facility Name
Odense University Hospital, Svendborg Sygehus
City
Svendborg
ZIP/Postal Code
5700
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Morten K Larsen, PhD
Email
morten.kobaek.larsen@rsyd.dk
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
32601101
Citation
Kaalby L, Deding U, Kobaek-Larsen M, Havshoi AV, Zimmermann-Nielsen E, Thygesen MK, Kroeijer R, Bjorsum-Meyer T, Baatrup G. Colon capsule endoscopy in colorectal cancer screening: a randomised controlled trial. BMJ Open Gastroenterol. 2020 Jun;7(1):e000411. doi: 10.1136/bmjgast-2020-000411.
Results Reference
derived
Learn more about this trial
Care for Colon 2015
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