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Care for Colon 2015 (CFC2015)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04049357
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
Morten Kobaek-Larsen, Odense University Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

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.



Primary Outcome Measures :
  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.



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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participation in the Danish colorectal screening program

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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


Contacts
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Contact: Gunnar Baatrup, Professor 0045 20575154 Gunnar.Baatrup@rsyd.dk
Contact: Thomas Bjørsum-Meyer, PhD 0045 27896080 Thomas.Bjoersum-Meyer@rsyd.dk

Locations
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Denmark
Odense University Hospital, Svendborg Sygehus Recruiting
Svendborg, Denmark, 5700
Contact: Morten K Larsen, PhD       morten.kobaek.larsen@rsyd.dk   
Sponsors and Collaborators
Odense University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Morten Kobaek-Larsen, Ass. professor, Odense University Hospital
ClinicalTrials.gov Identifier: NCT04049357    
Other Study ID Numbers: 0
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Morten Kobaek-Larsen, Odense University Hospital:
Camera Capsule Endoscopy
Colorectal cancer screening
Optical colonoscopy
Colorectal cancer
Additional relevant MeSH terms:
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Colorectal Neoplasms
Adenoma
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type