Computer-based Classification of Colorectal Polyps Using... | NCT01262248

Studies
Computer-based Classification of Colorectal Polyps Using Narrow-band Imaging

NCT01262248

Sponsor

Tischendorf, Jens, M.D.

Status

Completed

Last Update Posted

Jun 16, 2011Estimated

Enrollment

434Actual

Phase

Not provided

Conditions

Colorectal Polyps

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Dec 15, 2010

First Submission Date that Met QC Criteria

Dec 15, 2010

First Posted Date

Dec 17, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 15, 2011

Last Update Posted Date

Jun 16, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

434Actual

Label	Type	Description	Intervention Names
patients with colorectal polyps

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
diagnostic value (sensitivity, specificity, negative predictive value, positive predictive value, accuracy)		10 months

Secondary Outcomes

Measure	Description	Time Frame
interobserver variability		10 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients who underwent colonoscopy and colorectal polyps with a size of 10mm or smaller were detected

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jens Tischendorf, M.D.	Medical Department III, University Hospital Aachen (RWTH), Pauwelsstr. 30, 52074 Aachen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Medicine III, University Hospital Aachen (RWTH)		Aachen		52074	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19910250	Background	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.
19899031

ID	Term
D008679	Metaplasia
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms