Colon CancerNCT03052335
The Efficiency of Colon Capsule Endoscopy in Colon Cancer Screening
A study testing Pillcam® COLON 2 Capsule and Colonoscopy in people with Colon Cancer, run by Military University Hospital, Prague at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Pillcam® COLON 2 Capsule and Colonoscopy
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Mar 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 50 - 75 years
- asymptomatic (no enterorhagy, weight loss or anemia)
- signed informed consent with the study and with colonoscopy
Who cannot join
- 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
Show all 9Show fewer
- severe acute inflammatory bowel disease
- severe comorbidities; likely non-compliance of the patient
- no informed consent signed (with the study and/or with colonoscopy)
Trial locations and contacts
1 site in 1 country.
Czechia1 site, 1 recruiting
- Recruiting
Military University Hospital
Prague
Stepan Suchanek, Ph.D.
About this study
Official title: 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.
Read the 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.
- Conditions
- Colon Cancer
- Being tested
- Pillcam® COLON 2 Capsule, Colonoscopy
- Keywords
- colorectal cancer, screening, colon capsule, colonoscopy
- Medical subject headings
- Colonic Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pillcam® COLON 2 CapsuleDevice
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.
ColonoscopyProcedure or surgery
Optical colonoscopy is the standard method for evaluating the colon
| Study group | Role | What they receive |
|---|---|---|
| Pillcam® COLON 2 Capsule and colonoscopy | Experimental | Persons with positive immunochemical fecal occult blood tests will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards. Receives: Device: Pillcam® COLON 2 Capsule; Procedure: Colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Negative predictive value (NPV) of the CCE2 for large polyps (≥ 10 mm)
Measured: 1 day
Secondary outcomes (4)
CCE2 accuracy for detection of advanced adenomas
Measured: 1 day
CCE2 accuracy for detection of colon cancer
Measured: 1 day
CCE2 and optical colonoscopy acceptance (special questionnaire)
Measured: 1 day
Cost-effectiveness analyses: cost reduction of preventive colonoscopies spared
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study start1 Mar 2017
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military University Hospital, Prague
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University, Institute for Clinical and Experimental Medicine, University Hospital Hradec Kralove
- Responsible party
- Principal investigator, Stepan Suchanek, MD., Ph.D., Military University Hospital, Prague
- Investigators
- Stepan Suchanek, Study director, Military University Hospital, Prague
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03052335
- Sponsor's protocol ID
- 16-29614A
- Status last verified
- Jan 2019
- First submitted
- 31 Jan 2017
- Last updated
- 15 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of the Efficiency of Colon Capsule Endoscopy and Optical Colonoscopy in Patients With Positive Immunochemical Fecal Occult Blood Test
- ClinicalTrials.gov ID
- NCT03052335
- Acronym / sponsor ID
- 16-29614A
- Conditions
- Colon Cancer
- Keywords
- colorectal cancer, screening, colon capsule, colonoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Military University Hospital, PragueUniversity, hospital or other
- Collaborators
- Masaryk University, Institute for Clinical and Experimental Medicine, University Hospital Hradec Kralove
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pillcam® COLON 2 Capsule and colonoscopy | Experimental | Device: Pillcam® COLON 2 Capsule, Procedure: ColonoscopyPersons with positive immunochemical fecal occult blood tests will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 50 - 75 years
- asymptomatic (no enterorhagy, weight loss or anemia)
- signed informed consent with the study and with colonoscopy
Key exclusion criteria (9 listed)
- CRC high-risk group patients
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pillcam® COLON 2 CapsuleThe 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. | Device | Pillcam® COLON 2 Capsule and colonoscopy |
| ColonoscopyOptical colonoscopy is the standard method for evaluating the colon | Procedure or surgery | Pillcam® COLON 2 Capsule and colonoscopy |
Primary outcome
Negative predictive value (NPV) of the CCE2 for large polyps (≥ 10 mm)
Time frame: 1 day
4 secondary outcomes
CCE2 accuracy for detection of advanced adenomas
Time frame: 1 day
CCE2 accuracy for detection of colon cancer
Time frame: 1 day
CCE2 and optical colonoscopy acceptance (special questionnaire)
Time frame: 1 day
Cost-effectiveness analyses: cost reduction of preventive colonoscopies spared
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stepan Suchanek study director
Military University Hospital, Prague
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pillcam® COLON 2 Capsule and Colonoscopy in people with Colon Cancer, run by Military University Hospital, Prague at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stepan Suchanek, MD., Ph.D. (973208367 ext. 00420, stepan.suchanek@uvn.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Negative predictive value (NPV) of the CCE2 for large polyps (≥ 10 mm) (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2019.