Computer Assisted Selection of Serrated Adenomas and Neoplastic Polyps - a New Clinical DRAft (CASSANDRA I)

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

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.

Study Overview

• Status: Unknown
• Conditions: Polyps; Colonic Neoplasms; Adenoma Colon; Automatic Judgement
• Intervention / Treatment: Diagnostic test: Computer program

• Study Type: Observational
• Enrollment (Anticipated): 300

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for routine colonoscopy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Routine Colonoscopy Cohort; Photographies of polyps for creation of computer program	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the computer- made optical diagnosis of each colorectal polyp	The predicted polyp histology (made optically by the computer program) will be assessed; the predicted diagnosis will be compared with the histopathological diagnosis (gold standard) after resection of the polyp;	participants data will be followed for the duration of creating the computer program (an expected average of 2 month)

Collaborators and Investigators

• Sponsor: Technical University of Munich

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 15, 2018
• Primary Completion (ANTICIPATED): December 15, 2018
• Study Completion (ANTICIPATED): May 15, 2019

Study Registration Dates

• First Submitted: May 28, 2018
• First Submitted That Met QC Criteria: May 28, 2018
• First Posted (ACTUAL): June 8, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 8, 2018
• Last Update Submitted That Met QC Criteria: May 28, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Intestinal Neoplasms; Colorectal Neoplasms; Adenoma; Polyps; Colonic Neoplasms
• Other Study ID Numbers: CASSANDRA I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO