- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01262248
Computer-based Classification of Colorectal Polyps Using Narrow-band Imaging
June 15, 2011 updated by: Tischendorf, Jens, M.D.
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
434
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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Aachen, Germany, 52074
- Department of Medicine III, University Hospital Aachen (RWTH)
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients who underwent colonoscopy and colorectal polyps with a size of 10mm or smaller were detected
Description
Inclusion Criteria:
- All patients who did not meet the exclusion criteria were included in the study
Exclusion Criteria:
- 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
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
Cohorts and Interventions
Group / Cohort |
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patients with colorectal polyps
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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diagnostic value (sensitivity, specificity, negative predictive value, positive predictive value, accuracy)
Time Frame: 10 months
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10 months
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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interobserver variability
Time Frame: 10 months
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10 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jens Tischendorf, M.D., Medical Department III, University Hospital Aachen (RWTH), Pauwelsstr. 30, 52074 Aachen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Tischendorf 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.
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
May 1, 2010
Primary Completion (Actual)
February 1, 2011
Study Completion (Actual)
March 1, 2011
Study Registration Dates
First Submitted
December 15, 2010
First Submitted That Met QC Criteria
December 15, 2010
First Posted (Estimate)
December 17, 2010
Study Record Updates
Last Update Posted (Estimate)
June 16, 2011
Last Update Submitted That Met QC Criteria
June 15, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ti-NBI
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.
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