Care for Colon 2015

NCT04049357 | Completed FDA Device

• 1 other identifier: 0
• Study Type: interventional
• Target: 2,031
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Adenoma

Keywords

Camera Capsule Endoscopy; Colorectal cancer screening; Optical colonoscopy; Colorectal cancer

Outcome Measures

Primary Outcomes (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.

  Within 30 days

Study Arms (2)

The intervention group

EXPERIMENTAL

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

The control group

NO INTERVENTION

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.

Interventions

Camera Capsule Endoscopy/ PillCam DEVICE

Camera Capsule Endoscopy in screening

The intervention group

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participation in the Danish colorectal screening program

You may not qualify if:

• None

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital, Svendborg Sygehus

Svendborg, 5700, Denmark

Location

Related Publications (6)

• 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.

  PMID: 37364794 BACKGROUND

• 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.

  PMID: 39100485 BACKGROUND

• 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.

  PMID: 40210462 BACKGROUND

• 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.

  PMID: 34790535 BACKGROUND

• 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.

  PMID: 32601101 BACKGROUND

• 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? Therap Adv Gastroenterol. 2024 Oct 23;17:17562848241290256. doi: 10.1177/17562848241290256. eCollection 2024.

  PMID: 39449979 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Adenoma

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 5, 2019
• First Posted: August 8, 2019
• Study Start: August 3, 2020
• Primary Completion: January 31, 2024
• Study Completion: October 1, 2024
• Last Updated: October 2, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)