Colorectal PolypsNCT01262248
Computer-based Classification of Colorectal Polyps Using Narrow-band Imaging
An observational study of Colorectal Polyps, run by Tischendorf, Jens, M.D. at 1 site in Germany.
Trial summary
Recent studies have shown that narrow-band imaging (NBI) is a powerful diagnostic tool for the differentiation between neoplastic and non-neoplastic colorectal polyps. The aim of the present study is to develop and evaluate a computer-based method for automated classification of small colorectal polyps on the basis of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Polyps
- How many people
- 434 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Mar 2011
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who underwent colonoscopy and colorectal polyps with a size of 10mm or smaller were detected
Who may be able to join
- All patients who did not meet the exclusion criteria were included in the study
Who cannot join
- Patients with chronic inflammatory bowel disease, adenomatosis coli, coagulopathy, insufficient bowel preparation, or previous colonoscopy within the last 3 years; age under 18 years; no written informed consent for participation in the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Medicine III, University Hospital Aachen (RWTH)
Aachen, 52074
About this study
Official title: Computer-based Classification of Small Colorectal Polyps
Recent studies have shown that narrow-band imaging (NBI) is a powerful diagnostic tool for the differentiation between neoplastic and non-neoplastic colorectal polyps. The aim of the present study is to develop and evaluate a computer-based method for automated classification of small colorectal polyps on the basis of vascularization features.In a prospective study 207 polyps with a size of 10mm or smaller should be detected by a zoom NBI colonoscopy. These polyps were imaged and subsequently removed for histological analysis. the polyp images were analyzed by a computer algorithm. The proposed computer-based method consists of several steps: preprocessing, vessel segmentation, feature extraction and classification. The results of the automatic classification (sensitivity, specificity, negative predictive value, positive predictive value and accuracy)were compared to those of human observers, who were blinded to the histological gold standard.
- Conditions
- Colorectal Polyps
- Keywords
- small colorectal polyps, narrow band imaging, vascularization, computer-based classification
- Medical subject headings
- Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with colorectal polyps | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic value (sensitivity, specificity, negative predictive value, positive predictive value, accuracy)
Measured: 10 months
Secondary outcomes (1)
interobserver variability
Measured: 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startMay 2010
- Primary completionFeb 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal PolypsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tischendorf, Jens, M.D.
- Investigators
- Jens Tischendorf, M.D., Principal investigator, Medical Department III, University Hospital Aachen (RWTH), Pauwelsstr. 30, 52074 Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262248
- Sponsor's protocol ID
- Ti-NBI
- Status last verified
- Jun 2011
- First submitted
- 15 Dec 2010
- Last updated
- 16 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ignjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10.
PubMed 19910250Tischendorf JJ, Schirin-Sokhan R, Streetz K, Gassler N, Hecker HE, Meyer M, Tacke F, Wasmuth HE, Trautwein C, Winograd R. Value of magnifying endoscopy in classifying colorectal polyps based on vascular pattern. Endoscopy. 2010 Jan;42(1):22-7. doi: 10.1055/s-0029-1215268. Epub 2009 Nov 6.
PubMed 19899031
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-based Classification of Small Colorectal Polyps
- ClinicalTrials.gov ID
- NCT01262248
- Acronym / sponsor ID
- Ti-NBI
- Conditions
- Colorectal Polyps
- Keywords
- small colorectal polyps, narrow band imaging, vascularization, computer-based classification
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- Tischendorf, Jens, M.D.
- Study start
- May 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 17 Dec 2010 (estimated)
- 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.
Recent studies have shown that narrow-band imaging (NBI) is a powerful diagnostic tool for the differentiation between neoplastic and non-neoplastic colorectal polyps. The aim of the present study is to develop and evaluate a computer-based method for automated classification of small colorectal polyps on the basis of vascularization features.In a prospective study 207 polyps with a size of 10mm or smaller should be detected by a zoom NBI colonoscopy. These polyps were imaged and subsequently removed for histological analysis. the polyp images were analyzed by a computer algorithm. The proposed computer-based method consists of several steps: preprocessing, vessel segmentation, feature extraction and classification. The results of the automatic classification (sensitivity, specificity, negative predictive value, positive predictive value and accuracy)were compared to those of human observers, who were blinded to the histological gold standard.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with colorectal polyps | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who underwent colonoscopy and colorectal polyps with a size of 10mm or smaller were detected
Key inclusion criteria (1 listed)
- All patients who did not meet the exclusion criteria were included in the study
Key exclusion criteria (1 listed)
- Patients with chronic inflammatory bowel disease, adenomatosis coli, coagulopathy, insufficient bowel preparation, or previous colonoscopy within the last 3 years; age under 18 years; no written informed consent for participation in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
diagnostic value (sensitivity, specificity, negative predictive value, positive predictive value, accuracy)
Time frame: 10 months
1 secondary outcome
interobserver variability
Time frame: 10 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2011.
- Background: PubMed 19910250Ignjatovic A, East JE, Suzuki N, Vance M, Guenther T, Saunders BP. Optical diagnosis of small colorectal polyps at routine colonoscopy (Detect InSpect ChAracterise Resect and Discard; DISCARD trial): a prospective cohort study. Lancet Oncol. 2009 Dec;10(12):1171-8. doi: 10.1016/S1470-2045(09)70329-8. Epub 2009 Nov 10.
- Background: PubMed 19899031Tischendorf JJ, Schirin-Sokhan R, Streetz K, Gassler N, Hecker HE, Meyer M, Tacke F, Wasmuth HE, Trautwein C, Winograd R. Value of magnifying endoscopy in classifying colorectal polyps based on vascular pattern. Endoscopy. 2010 Jan;42(1):22-7. doi: 10.1055/s-0029-1215268. Epub 2009 Nov 6.
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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.
Jens Tischendorf, M.D. principal investigator
Medical Department III, University Hospital Aachen (RWTH), Pauwelsstr. 30, 52074 Aachen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Polyps, run by Tischendorf, Jens, M.D. at 1 site in Germany.
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: finished, as of the sponsor's last update on 16 Jun 2011. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic value (sensitivity, specificity, negative predictive value, positive predictive value, accuracy) (time frame: 10 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01262248, which also lists 2 linked publications.
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 16 Jun 2011; AzTrials last refreshed its copy on 30 Oct 2026.