Clinical trial NCT03052335: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Keywords: colorectal cancer
screening
colon capsule
colonoscopy
Lead sponsor: Military University Hospital, Prague
Sponsor class: OTHER
Collaborators: name: Masaryk University
name: Institute for Clinical and Experimental Medicine
name: University Hospital Hradec Kralove
First posted: 2017-02-14
Enrollment: 230
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

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)

Primary outcomes:
measure: Negative predictive value (NPV) of the CCE2 for large polyps (≥ 10 mm)
timeFrame: 1 day
Secondary outcomes:
measure: CCE2 accuracy for detection of advanced adenomas
timeFrame: 1 day
measure: CCE2 accuracy for detection of colon cancer
timeFrame: 1 day
measure: CCE2 and optical colonoscopy acceptance (special questionnaire)
timeFrame: 1 day
measure: Cost-effectiveness analyses: cost reduction of preventive colonoscopies spared
timeFrame: 1 day
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Military University Hospital
Study officials:
affiliation: Military University Hospital, Prague
name: Stepan Suchanek
role: STUDY_DIRECTOR
References: