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

NCT03550625 | Unknown

• 1 other identifier: CASSANDRA I
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Routine Colonoscopy Cohort

Photographies of polyps for creation of computer program

Diagnostic Test: Computer program

Interventions

Computer program 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.

Routine Colonoscopy Cohort

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for routine colonoscopy

You may qualify if:

• indication for colonoscopy
• patients \>= 18 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Technical University of Munich: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

Colonic polyps

MeSH Terms

Conditions

Polyps; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2018
• First Posted: June 8, 2018
• Study Start: July 15, 2018
• Primary Completion: December 15, 2018
• Study Completion: May 15, 2019
• Last Updated: June 8, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share