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The Efficiency of Colon Capsule Endoscopy in Colon Cancer Screening

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ClinicalTrials.gov Identifier: NCT03052335
Recruitment Status : Recruiting
First Posted : February 14, 2017
Last Update Posted : September 7, 2017
Sponsor:
Collaborators:
Masaryk University
Institute for Clinical and Experimental Medicine
University Hospital Hradec Kralove
Information provided by (Responsible Party):
Stepan Suchanek, MD., Ph.D., Military University Hospital, Prague

Brief Summary:
Main objective is to improve colorectal cancer (CRC) screening programme in the Czech Republic and decrease the disease incidence and mortality. The secondary aim is to verify the effectiveness of incorporation of the new minimally invasive device in the prevention programme.

Condition or disease Intervention/treatment Phase
Colon Cancer Device: Pillcam® COLON 2 Capsule Procedure: Colonoscopy Not Applicable

Detailed Description:

Multicentre, multidisciplinary (3 gastroenterology units; biostatistics department; cooperation with general practitioners), prospective study is focused on examination of individuals with average colorectal cancer (CRC) risk (asymptomatic, age 50-75 years).

In years 2017 - 2019, there will be 230 persons with positive semi-quantitative immunochemical fecal occult blood tests (FIT; QuikRead, Orion Diagnostica Oy, Finland) with cut-off level 75 ng/ml involved. Every person will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards.

Main objective is to show that the negative predictive value (NPV) of the CCE2 applied in patients with positive FIT results is sufficient to include this method in the National CRC screening as filter test with aim to reduce the necessity of subsequent optical colonoscopy.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: The Comparison of the Efficiency of Colon Capsule Endoscopy and Optical Colonoscopy in Patients With Positive Immunochemical Fecal Occult Blood Test
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pillcam® COLON 2 Capsule and colonoscopy
Persons with positive immunochemical fecal occult blood tests will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards.
Device: Pillcam® COLON 2 Capsule
The second generation of PillCam colon capsule endoscopy (CCE-2) is 11.6 mm × 31.5 mm in size and has two imagers, that each have a 172° angle of view, allowing for almost 360° visual coverage of the colon. CCE-2 has an adaptive frame rate from 4 to 35 images per second. This means that the camera is able to capture up to 35 pictures while in motion whereas 4 images per second are captured when it is virtually stationary. During the examination the patient wears a sensor array which is attached to the abdomen and a data recorder for storage of the information generated by the ingested capsule. After the examination the data are downloaded into the workstation and a video is generated.

Procedure: Colonoscopy
Optical colonoscopy is the standard method for evaluating the colon




Primary Outcome Measures :
  1. Negative predictive value (NPV) of the CCE2 for large polyps (≥ 10 mm) [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. CCE2 accuracy for detection of advanced adenomas [ Time Frame: 1 day ]
  2. CCE2 accuracy for detection of colon cancer [ Time Frame: 1 day ]
  3. CCE2 and optical colonoscopy acceptance (special questionnaire) [ Time Frame: 1 day ]
  4. Cost-effectiveness analyses: cost reduction of preventive colonoscopies spared [ Time Frame: 1 day ]


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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • age 50 - 75 years
  • asymptomatic (no enterorhagy, weight loss or anemia)
  • signed informed consent with the study and with colonoscopy

Exclusion Criteria:

  • CRC high-risk group patients

    • having first degree relatives diagnosed with colorectal cancer at age ˂ 60 years
    • FAP, HNPCC and other hereditary CRC syndromes probands
    • positive personal medical history of colorectal neoplasia (advanced adenomatous polyp, colorectal cancer)
  • recent diagnostic, follow-up or preventive colonoscopy in ≤ 3 years (FOBT-positive colonoscopy, screening colonoscopy)
  • colonoscopy contraindication
  • severe acute inflammatory bowel disease
  • severe comorbidities; likely non-compliance of the patient
  • no informed consent signed (with the study and/or with colonoscopy)

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): NCT03052335


Contacts
Contact: Stepan Suchanek, MD., Ph.D. 973208367 ext 00420 stepan.suchanek@uvn.cz
Contact: Michal Voska 773200360 ext 00420 michal.voska@uvn.cz

Locations
Czechia
Military University Hospital Recruiting
Prague, Czechia
Contact: Stepan Suchanek, Ph.D.         
Sponsors and Collaborators
Military University Hospital, Prague
Masaryk University
Institute for Clinical and Experimental Medicine
University Hospital Hradec Kralove
Investigators
Study Director: Stepan Suchanek Military University Hospital, Prague

Responsible Party: Stepan Suchanek, MD., Ph.D., Head of Department of Gastrointestinal Endoscopy, Military University Hospital, Prague
ClinicalTrials.gov Identifier: NCT03052335     History of Changes
Other Study ID Numbers: 16-29614A
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: September 7, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Stepan Suchanek, MD., Ph.D., Military University Hospital, Prague:
colorectal cancer
screening
colon capsule
colonoscopy

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases