Computer-based Classification of Colorectal Polyps Using Narrow-band Imaging
| Tracking Information | |||||
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| First Received Date ICMJE | December 15, 2010 | ||||
| Last Updated Date | June 15, 2011 | ||||
| Start Date ICMJE | May 2010 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
diagnostic value (sensitivity, specificity, negative predictive value, positive predictive value, accuracy) [ Time Frame: 10 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01262248 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
interobserver variability [ Time Frame: 10 months ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Computer-based Classification of Colorectal Polyps Using Narrow-band Imaging | ||||
| Official Title ICMJE | Computer-based Classification of Small Colorectal Polyps | ||||
| Brief 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 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | patients who underwent colonoscopy and colorectal polyps with a size of 10mm or smaller were detected |
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| Condition ICMJE | Colorectal Polyps | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | patients with colorectal polyps | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 434 | ||||
| Completion Date | March 2011 | ||||
| Primary Completion Date | February 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01262248 | ||||
| Other Study ID Numbers ICMJE | Ti-NBI | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Tischendorf, Jens, M.D., Department of Medicine III, University of Aachen (RWTH) | ||||
| Study Sponsor ICMJE | Tischendorf, Jens, M.D. | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Tischendorf, Jens, M.D. | ||||
| Verification Date | June 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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