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

Colonic Neoplasms Clinical Trial

— CASSANDRA I  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03550625
• Other study ID #: CASSANDRA I
• Status: Not yet recruiting
• Start date: July 15, 2018
• Est. completion date: May 15, 2019

Study information

• Verified date: May 2018
• Source: Technische Universität München
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: May 15, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Automatic Judgement
• Colonic Neoplasms
• Polyps

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität München

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)