The Efficiency of Colon Capsule Endoscopy in Colon Cancer Screening
January 14, 2019 updated by: Stepan Suchanek, MD., Ph.D., Military University Hospital, Prague
The Comparison of the Efficiency of Colon Capsule Endoscopy and Optical Colonoscopy in Patients With Positive Immunochemical Fecal Occult Blood Test
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
230
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Prague, Czechia
- Recruiting
- Military University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SCREENING
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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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.
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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.
Optical colonoscopy is the standard method for evaluating the colon
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Negative predictive value (NPV) of the CCE2 for large polyps (≥ 10 mm)
Time Frame: 1 day
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1 day
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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CCE2 accuracy for detection of advanced adenomas
Time Frame: 1 day
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1 day
|
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CCE2 accuracy for detection of colon cancer
Time Frame: 1 day
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1 day
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CCE2 and optical colonoscopy acceptance (special questionnaire)
Time Frame: 1 day
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1 day
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Cost-effectiveness analyses: cost reduction of preventive colonoscopies spared
Time Frame: 1 day
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1 day
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Stepan Suchanek, Military University Hospital, Prague
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2017
Primary Completion (ANTICIPATED)
December 31, 2019
Study Completion (ANTICIPATED)
December 31, 2019
Study Registration Dates
First Submitted
January 31, 2017
First Submitted That Met QC Criteria
February 9, 2017
First Posted (ACTUAL)
February 14, 2017
Study Record Updates
Last Update Posted (ACTUAL)
January 15, 2019
Last Update Submitted That Met QC Criteria
January 14, 2019
Last Verified
January 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-29614A
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.