Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology

Colonic Neoplasms Clinical Trial

— SAVE  

Official title:

Saving by Artificial Intelligence for Virtual Endoscopy Biopsy Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06041945
• Other study ID #: 3483 - SAVE
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2023
• Est. completion date: September 1, 2027

Study information

• Verified date: September 2023
• Source: Istituto Clinico Humanitas
• Contact: Cesare Hassan
• Phone: 02-82247385
• Email: cesare.hassan[@]hunimed.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This three parallel-arms, randomized, multicenter trial is aimed at investigating the value of AI-assisted optical biopsy for differentiating between neoplastic and non-neoplastic polyps which will lead to the implementation of cost-saving strategies in screening programs. A cost-effectiveness analyses with the use of modern trial emulation analyses of large observational and clinical trial datasets and real-cost data will be conducted. To improve personalized treatment with a novel colonoscopy CADx risk-prediction tool, the investigators will even develop a novel deep learning algorithm for the optical biopsy of the alternative pathway of colorectal cancer carcinogenesis, namely the serrated pathway and develop cost-effectiveness models of AI-assisted optical biopsy in colorectal cancer screening that provides reliable information to identify cancer risk regardless of physicians' skill.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1800
• Est. completion date: September 1, 2027
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• All >40 years-old patients undergoing colonoscopy for selected indications

Exclusion Criteria:

• patients with personal history of CRC, or IBD

• patients affected with Lynch syndrome or Familiar Adenomatous Polyposis.

• patients with inadequate bowel preparation (defined as Boston Bowel Preparation Scale <2 in any colonic segment).

• patients with previous colonic resection.

• patients on antithrombotic therapy, precluding polyp resection.

• patients who were not able or refused to give informed written consent.

Related Conditions & MeSH terms

• Colonic Neoplasms

Intervention

Device:
• Standard, high-definition colonoscopy with the use of CADe assistance
All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
• Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ
All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology.
• Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ
Polyps will be left in situ if diminutive (=5 mm) in size, located in the rectum or sigma and optically diagnosed by the endoscopist using the system to be hyperplastic with high confidence, otherwise resected and sent to pathology.

Locations

Country	Name	City	State
Italy	Istituto Clinico Humanitas	Rozzano	Milano
Italy	Istituto Clinico Humanitas	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Non-inferiority in Adenoma Detection Rate	Non-inferiority in the Adenoma Detection Rate, defined as the proportion of participants with at least one adenoma (per-patient analysis) in the three arms, when adopting a cost-saving leave-in-situ strategy for non-neoplastic rectosigmoid diminutive polyps.	4 years
Secondary	Negative Predictive Value for colorectal neoplasia	Negative Predictive Value for colorectal neoplasia when adopting a leave-in-situ strategy for rectosigmoid diminutive polyps based on the use of Artificial Intelligence.	4 years
Secondary	Concordance between post-polypectomy surveillance and when adopting a leave-in-situ strategy	Concordance between post-polypectomy surveillance based on strategies based on optical diagnosis with Artificial Intelligence and those based on histology, and when adopting a leave-in-situ strategy for colorectal diminutive polyps based on the use of Artificial Intelligence	4 years
Secondary	Change in the cost of polypectomy and histology in screening programs	Change in the cost of polypectomy and histology in screening programs, when implementing strategies based on Artificial Intelligence-based optical biopsy, without changes in benefit related with detection of colorectal neoplasia	4 years