Computer Assisted Selection of Serrated Adenomas and Neoplastic Polyps - a New Clinical DRAft

NCT ID: NCT03550625

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-15
• Study Completion Date: 2019-05-15

Brief Summary

The aim of the study is to develop a computer program which is able to classify different entities of colorectal polyps on the basis of optical polyp features. In the end, the computer program shall differentiate between (i) hypeplastic polyps, (ii) adenomas and (iii) serrated adenomas .

In the first phase of the study a computer program will be established which aims to distinguish between the above mentions entities on the basis of optical features derived from still images. A machine learning apporach will be used for creating the program. Afterwards, in a second phase of the study, still images of 100 polyps (not used in the first phase) will be presented to the computer program. Quality of the computer program will be tested by calculating the accuracy for differentiating the three different polyp types. The gold standard for true polyp diagnoses will be based on histopathological diagnoses of the polyps. The same pictures of 100 polyps will also be presented to human experts. Experts will also predict histopathological diagnoses on the basis of optical polyps featurs. Accuracy of computer-decisions and human expert predictions will be compared. The establishment of a well- functioning computer program is the primary aim of the study.

Conditions

Polyps; Adenoma Colon; Automatic Judgement; Colonic Neoplasms

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Routine Colonoscopy Cohort

Photographies of polyps for creation of computer program

Computer program

Intervention Type: DIAGNOSTIC_TEST

No study specific intervention. Still images of polyps are collected. Histopathological reports of the resected polyps will be evaluated in order to create a computer program.

Interventions

Computer program

No study specific intervention. Still images of polyps are collected. Histopathological reports of the resected polyps will be evaluated in order to create a computer program.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• indication for colonoscopy
• patients >= 18 years

Exclusion Criteria

• pregnant women
• indication for colonoscopy: inflammatory bowel disease
• indication for colonoscopy: polyposis syndrome
• indication for colonoscopy: emergency colonoscopy e.g. acute bleeding
• contraindication for polyp resection e.g. patients on warfarin

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Technical University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

CASSANDRA I

Identifier Type: -

Identifier Source: org_study_id