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The Efficiency of Colon Capsule Endoscopy in Colon Cancer Screening

Primary Purpose

Colon Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Pillcam® COLON 2 Capsule
Colonoscopy
Sponsored by
Military University Hospital, Prague
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colon Cancer focused on measuring colorectal cancer, screening, colon capsule, colonoscopy

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Military University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pillcam® COLON 2 Capsule and colonoscopy

Arm Description

Persons with positive immunochemical fecal occult blood tests will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards.

Outcomes

Primary Outcome Measures

Negative predictive value (NPV) of the CCE2 for large polyps (≥ 10 mm)

Secondary Outcome Measures

CCE2 accuracy for detection of advanced adenomas
CCE2 accuracy for detection of colon cancer
CCE2 and optical colonoscopy acceptance (special questionnaire)
Cost-effectiveness analyses: cost reduction of preventive colonoscopies spared

Full Information

First Posted
January 31, 2017
Last Updated
January 14, 2019
Sponsor
Military University Hospital, Prague
Collaborators
Masaryk University, Institute for Clinical and Experimental Medicine, University Hospital Hradec Kralove
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1. Study Identification

Unique Protocol Identification Number
NCT03052335
Brief Title
The Efficiency of Colon Capsule Endoscopy in Colon Cancer Screening
Official Title
The Comparison of the Efficiency of Colon Capsule Endoscopy and Optical Colonoscopy in Patients With Positive Immunochemical Fecal Occult Blood Test
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Military University Hospital, Prague
Collaborators
Masaryk University, Institute for Clinical and Experimental Medicine, University Hospital Hradec Kralove

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
colorectal cancer, screening, colon capsule, colonoscopy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
230 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Pillcam® COLON 2 Capsule and colonoscopy
Arm Type
Experimental
Arm Description
Persons with positive immunochemical fecal occult blood tests will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards.
Intervention Type
Device
Intervention Name(s)
Pillcam® COLON 2 Capsule
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Colonoscopy
Intervention Description
Optical colonoscopy is the standard method for evaluating the colon
Primary Outcome Measure Information:
Title
Negative predictive value (NPV) of the CCE2 for large polyps (≥ 10 mm)
Time Frame
1 day
Secondary Outcome Measure Information:
Title
CCE2 accuracy for detection of advanced adenomas
Time Frame
1 day
Title
CCE2 accuracy for detection of colon cancer
Time Frame
1 day
Title
CCE2 and optical colonoscopy acceptance (special questionnaire)
Time Frame
1 day
Title
Cost-effectiveness analyses: cost reduction of preventive colonoscopies spared
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stepan Suchanek, MD., Ph.D.
Phone
973208367
Ext
00420
Email
stepan.suchanek@uvn.cz
First Name & Middle Initial & Last Name or Official Title & Degree
Michal Voska
Phone
773200360
Ext
00420
Email
michal.voska@uvn.cz
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stepan Suchanek
Organizational Affiliation
Military University Hospital, Prague
Official's Role
Study Director
Facility Information:
Facility Name
Military University Hospital
City
Prague
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stepan Suchanek, Ph.D.

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

The Efficiency of Colon Capsule Endoscopy in Colon Cancer Screening

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