NCT01262248

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
434

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

June 16, 2011

Status Verified

June 1, 2011

Enrollment Period

9 months

First QC Date

December 15, 2010

Last Update Submit

June 15, 2011

Conditions

Keywords

small colorectal polypsnarrow band imagingvascularizationcomputer-based classification

Outcome Measures

Primary Outcomes (1)

  • diagnostic value (sensitivity, specificity, negative predictive value, positive predictive value, accuracy)

    10 months

Secondary Outcomes (1)

  • interobserver variability

    10 months

Study Arms (1)

patients with colorectal polyps

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine III, University Hospital Aachen (RWTH)

Aachen, 52074, Germany

Location

Related Publications (2)

  • 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.

    PMID: 19910250BACKGROUND
  • 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.

    PMID: 19899031BACKGROUND

MeSH Terms

Conditions

Neovascularization, Pathologic

Condition Hierarchy (Ancestors)

MetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jens Tischendorf, M.D.

    Medical Department III, University Hospital Aachen (RWTH), Pauwelsstr. 30, 52074 Aachen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDIV

Study Record Dates

First Submitted

December 15, 2010

First Posted

December 17, 2010

Study Start

May 1, 2010

Primary Completion

February 1, 2011

Study Completion

March 1, 2011

Last Updated

June 16, 2011

Record last verified: 2011-06

Locations