CFC2015: Care for Colon 2015

Sponsor

Odense University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04049357

Collaborator

(none)

2,015

Enrollment

Location

Arms

Anticipated Duration (Months)

37.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Cancer Adenoma	Device: Camera Capsule Endoscopy/ PillCam	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2015 participants

Allocation:

Randomized

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.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)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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.

Outcome Measures

Primary Outcome Measures

CCE detection rate of polyps compared to OC [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participation in the Danish colorectal screening program

Exclusion Criteria:

None

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Odense University Hospital, Svendborg Sygehus	Svendborg		Denmark	5700

Sponsors and Collaborators

Odense University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Morten Kobaek-Larsen, Ass. professor, Odense University Hospital

ClinicalTrials.gov Identifier:

NCT04049357

Other Study ID Numbers:

First Posted:

Aug 8, 2019

Last Update Posted:

Sep 16, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Yes

Keywords provided by Morten Kobaek-Larsen, Ass. professor, Odense University Hospital

Camera Capsule Endoscopy

Colorectal cancer screening

Optical colonoscopy

Colorectal cancer

Additional relevant MeSH terms:

Colorectal Neoplasms

Adenoma

Study Results

No Results Posted as of Sep 16, 2021