Colon PolypNCT03069833
Computer Aided Diagnosis of Colorectal Neoplasms During Colonoscopic Examination
A study testing Computer-aided diagnosis in people with Colon Polyp, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
Trial summary
An NBI-based diagnosis requires training and experience. We are developing a system of computerized image recognition, which can detect possible NBI features of polyps, and provide a more objective diagnosis, which allows nonexpert endoscopists to achieve a high diagnostic accuracy. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Polyp
- What is being tested?
- Computer-aided diagnosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Mar 2017to Dec 2017
- 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 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- the same as colonoscopy
Who cannot join
- the same as colonoscopy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Endoscopy Center, Tri-Service General Hospital
Taipei, 114
Peng-Jen Chen, MD, +886-87923311 ext. 88056, endoscopy@ndmctsgh.edu.tw
About this study
An NBI-based diagnosis requires training and experience. We are developing a system of computerized image recognition, which can detect possible NBI features of polyps, and provide a more objective diagnosis, which allows nonexpert endoscopists to achieve a high diagnostic accuracy.
- Conditions
- Colon Polyp
- Being tested
- Computer-aided diagnosis
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-aided diagnosisDiagnostic test
computer-aided diagnosis to assist colonoscopists
| Study group | Role | What they receive |
|---|---|---|
| Computer-aided diagnosis | Experimental | Not described Receives: Diagnostic Test: Computer-aided diagnosis |
| traditional diagnosis | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity, Specificity, False Positive, False Negative
Diagnostic accuracy
Measured: Duration between endoscopic diagnosis and pathologic diagnosis is about one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start1 Mar 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PolypStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tri-Service General Hospital (TSGH)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peng-Jen Chen, Tri-Service General Hospital (TSGH)
- Investigators
- Peng-Jen Chen, MD, Principal investigator, Tri-Service General Hospital, National Defense Medical Center, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03069833
- Sponsor's protocol ID
- 2-105-05-061
- Status last verified
- Mar 2017
- First submitted
- 28 Feb 2017
- Last updated
- 28 Mar 2017
- Results posted
- No
- Data monitoring committee
- 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 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer Aided Diagnosis of Colorectal Neoplasms During Colonoscopic Examination
- ClinicalTrials.gov ID
- NCT03069833
- Acronym / sponsor ID
- 2-105-05-061
- Conditions
- Colon Polyp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tri-Service General Hospital (TSGH)University, hospital or other
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Mar 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.
An NBI-based diagnosis requires training and experience. We are developing a system of computerized image recognition, which can detect possible NBI features of polyps, and provide a more objective diagnosis, which allows nonexpert endoscopists to achieve a high diagnostic accuracy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computer-aided diagnosis | Experimental | Diagnostic Test: Computer-aided diagnosis |
| traditional diagnosis | No intervention | – |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- the same as colonoscopy
Key exclusion criteria (1 listed)
- the same as colonoscopy
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 |
|---|---|---|
| Computer-aided diagnosiscomputer-aided diagnosis to assist colonoscopists | Diagnostic test | Computer-aided diagnosis |
Primary outcome
Sensitivity, Specificity, False Positive, False Negative
Time frame: Duration between endoscopic diagnosis and pathologic diagnosis is about one week
Diagnostic accuracy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
- 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.
Peng-Jen Chen, MD principal investigator
Tri-Service General Hospital, National Defense Medical Center, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-aided diagnosis in people with Colon Polyp, run by Tri-Service General Hospital (TSGH) at 1 site in Taiwan.
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 1 inclusion and 1 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 28 Mar 2017. 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 Taiwan. 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 Peng-Jen Chen, MD (+886-87923311 ext. 88056, endoscopy@ndmctsgh.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity, Specificity, False Positive, False Negative (time frame: Duration between endoscopic diagnosis and pathologic diagnosis is about one week). 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 28 Mar 2017.