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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03550625
Acronym
CASSANDRA I
Enrollment
300
Registered
2018-06-08
Start date
2018-07-15
Completion date
2019-05-15
Last updated
2018-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyps, Adenoma Colon, Automatic Judgement, Colonic Neoplasms

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.

Interventions

DIAGNOSTIC_TESTComputer 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.

Sponsors

Technical University of Munich
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of the computer- made optical diagnosis of each colorectal polypparticipants data will be followed for the duration of creating the computer program (an expected average of 2 month)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;

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026