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Colorectal CancerCFC2015NCT04049357

Care for Colon 2015

A study testing Camera Capsule Endoscopy/ PillCam in people with Colorectal Cancer and Adenoma, run by Odense University Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 74 years
Conditions the study is for
Colorectal Cancer, Adenoma
What is being tested?
Camera Capsule Endoscopy/ PillCam
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,031 participants
Where
1 siteDenmark
Study dates
3 Aug 2020to 1 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participation in the Danish colorectal screening program

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Odense University Hospital, Svendborg Sygehus

    Svendborg, 5700

Other trials in Denmark

About this study

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

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.

Read the 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.

Being tested
Camera Capsule Endoscopy/ PillCam
Keywords
Camera Capsule Endoscopy, Colorectal cancer screening, Optical colonoscopy, Colorectal cancer
Medical subject headings
Colorectal Neoplasms, Adenoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Camera Capsule Endoscopy/ PillCamDevice

    Camera Capsule Endoscopy in screening

Study groups in NCT04049357
Study groupRoleWhat they receive
The intervention groupExperimentalIf 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.
Receives: Device: Camera Capsule Endoscopy/ PillCam
The control groupNo interventionThe 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Aug 2019
  2. Study start3 Aug 2020
  3. Primary completion31 Jan 2024
  4. Study completion1 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
2,031 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04049357
Sponsor's protocol ID
0
Acronym
CFC2015
Status last verified
Apr 2024
First submitted
5 Aug 2019
Last updated
2 Oct 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Deding U, Boggild H, Baatrup G, Kaalby L, Hjelmborg J, Thygesen MK, Schelde-Olesen B, Kobaek-Larsen M; CareForColon2015 study group. Socioeconomic differences in expected discomfort from colonoscopy and colon capsule endoscopy. Prev Med. 2023 Aug;173:107593. doi: 10.1016/j.ypmed.2023.107593. Epub 2023 Jun 24.

    PubMed 37364794

  • Deding U, Boggild H, Kaalby L, Hjelmborg J, Kobaek-Larsen M, Thygesen MK, Schelde-Olesen B, Bjorsum-Meyer T, Baatrup G; CareForColon2015 study group. Socioeconomic differences in discrepancies between expected and experienced discomfort from colonoscopy and colon capsule endoscopy. Heliyon. 2024 Jul 8;10(14):e34274. doi: 10.1016/j.heliyon.2024.e34274. eCollection 2024 Jul 30.

    PubMed 39100485

  • Baatrup G, Bjorsum-Meyer T, Kaalby L, Schelde-Olesen B, Kobaek-Larsen M, Koulaouzidis A, Kroijer R, Al-Najami I, Buch N, Hogh A, Qvist N, Thygesen MK, Deding U; CareForColon2015 study group. Choice of colon capsule or colonoscopy versus default colonoscopy in FIT positive patients in the Danish screening programme: a parallel group randomised controlled trial. Gut. 2025 Sep 8;74(10):1616-1623. doi: 10.1136/gutjnl-2024-333687.

    PubMed 40210462

  • Deding U, Bjorsum-Meyer T, Kaalby L, Kobaek-Larsen M, Thygesen MK, Madsen JB, Kroijer R, Baatrup G. Colon capsule endoscopy in colorectal cancer screening: Interim analyses of randomized controlled trial CareForColon2015. Endosc Int Open. 2021 Nov 12;9(11):E1712-E1719. doi: 10.1055/a-1546-8727. eCollection 2021 Nov.

    PubMed 34790535

  • 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.

    PubMed 32601101

  • Nadimi ES, Braun JM, Schelde-Olesen B, Khare S, Gogineni VC, Blanes-Vidal V, Baatrup G. Towards full integration of explainable artificial intelligence in colon capsule endoscopy's pathway. Sci Rep. 2025 Feb 18;15(1):5960. doi: 10.1038/s41598-025-89648-z.

    PubMed 39966538

  • Schelde-Olesen B, Koulaouzidis A, Deding U, Toth E, Dabos KJ, Eliakim A, Carretero C, Gonzalez-Suarez B, Dray X, de Lange T, Beaumont H, Rondonotti E, Kopylov U, Ellul P, Perez-Cuadrado-Robles E, Robertson A, Stenfors I, Bojorquez A, Piccirelli S, Raabe GG, Margalit-Yehuda R, Barba I, Scardino G, Ouazana S, Bjorsum-Meyer T. Bowel cleansing quality evaluation in colon capsule endoscopy: what is the reference standard? Ther Adv Gastroenterol. 2024 Oct 23;17:17562848241290256. doi: 10.1177/17562848241290256. eCollection 2024.

    PubMed 39449979

Questions about this trial

What is this clinical trial studying?

A study testing Camera Capsule Endoscopy/ PillCam in people with Colorectal Cancer and Adenoma, run by Odense University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CCE detection rate of polyps compared to OC (time frame: Within 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04049357, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

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