Periodic Reporting for period 2 - OperA (OPTIMISING COLORECTAL CANCER PREVENTION TROUGH PERSONALISED TREATMENT WITH ARTIFICIAL INTELLIGENCE)
Berichtszeitraum: 2024-03-01 bis 2025-08-31
The OperA project is a multidisciplinary project with eight different work packages (WPs) to optimize colorectal cancer prevention through personalized treatment with artificial intelligence. The following specific goal for each work package will help achieve this overarching goal.
WP1. Establish the value of artificial intelligence (AI)-assisted colonoscopy in colorectal cancer prevention by conducting a pan-European, population-based, randomised trial.
WP2. Develop a colonoscopy AI risk-prediction tool for personalized treatment of colorectal polyps and cancer.
WP3. Develop cost-effectiveness models of AI-assisted colonoscopy in colorectal cancer screening.
WP4. Investigate ethical and legal barriers in AI development and implementation.
WP5. Generate the first trustworthy and rapidly updated (“living”) clinical guidelines for AI in screening colonoscopy.
WP6, 7, and 8. Facilitate patient-oriented dissemination, communication, and management of the project.
WP1. Establish the value of artificial intelligence (AI)-assisted colonoscopy in colorectal cancer prevention by conducting a pan-European, population-based, randomised trial.
WP2. Develop a colonoscopy AI risk-prediction tool for personalized treatment of colorectal polyps and cancer.
WP3. Develop cost-effectiveness models of AI-assisted colonoscopy in colorectal cancer screening.
WP4. Investigate ethical and legal barriers in AI development and implementation.
WP5. Generate the first trustworthy and rapidly updated (“living”) clinical guidelines for AI in screening colonoscopy.
WP6, 7, and 8. Facilitate patient-oriented dissemination, communication, and management of the project.
Here, we provide short summary of the progress of each of the scientific WPs (WP1-5).
WP 1: We are conducting a pan-European, randomized trial to achieve this goal. Establishment of the trial infrastructure (ethics approval, clinical trial registration with the summary of the protocol) has been successfully achieved. Following this, we have included 39,138 patients as of August 2025.
WP2: We are developing an AI-based pathology prediction tool for colorectal lesions. The first one and half years have been spent primarily for preparation of the study infrastructure including ethics approval of hospitals in six countries (Norway, Germany, Poland, Italy, Spain, and Japan), development of the cloud-based data storage system in the UK, and development of the preliminary, semi-supervised learning algorithm. In line with the ethics approval, we have already started collection of more than 60,000 endoscopic images. In line with development of the AI algorithm we have been communication with a consultation company which supports smooth applicaiton for EU-MDR approval.
WP3: We have developed and published a brand-new microsimulation model with the use of trustworthy clinical data derived from large-scale prospective studies. The resulting effectiveness data has been used as an evidence base to develop trustworthy guidelines in a close collaboration with WP5.
WP4: We have organized the ethics monitoring committee to audit if development of the AI tool in WP2 is done in an ethically acceptable way. We have also organized the position statement committee to address ethics and regulations in AI in colonoscopy which was just accepted in Annals of Internal Medicine. We have also published several other articles in major journals with a strong focus on ethics and legal issues in AI.
WP 5: We are closely working with MAGIC Foundation to publish trustworthy and rapid recommendations on AI in colonoscopy screening. We have organized a guidelines committee and published the living guideline in BMJ. The guideline-work includes selection of panel members, identification of the PICO question, development of the systematic review, and drafting the recommendations based on the voting by the panel members.
WP 1: We are conducting a pan-European, randomized trial to achieve this goal. Establishment of the trial infrastructure (ethics approval, clinical trial registration with the summary of the protocol) has been successfully achieved. Following this, we have included 39,138 patients as of August 2025.
WP2: We are developing an AI-based pathology prediction tool for colorectal lesions. The first one and half years have been spent primarily for preparation of the study infrastructure including ethics approval of hospitals in six countries (Norway, Germany, Poland, Italy, Spain, and Japan), development of the cloud-based data storage system in the UK, and development of the preliminary, semi-supervised learning algorithm. In line with the ethics approval, we have already started collection of more than 60,000 endoscopic images. In line with development of the AI algorithm we have been communication with a consultation company which supports smooth applicaiton for EU-MDR approval.
WP3: We have developed and published a brand-new microsimulation model with the use of trustworthy clinical data derived from large-scale prospective studies. The resulting effectiveness data has been used as an evidence base to develop trustworthy guidelines in a close collaboration with WP5.
WP4: We have organized the ethics monitoring committee to audit if development of the AI tool in WP2 is done in an ethically acceptable way. We have also organized the position statement committee to address ethics and regulations in AI in colonoscopy which was just accepted in Annals of Internal Medicine. We have also published several other articles in major journals with a strong focus on ethics and legal issues in AI.
WP 5: We are closely working with MAGIC Foundation to publish trustworthy and rapid recommendations on AI in colonoscopy screening. We have organized a guidelines committee and published the living guideline in BMJ. The guideline-work includes selection of panel members, identification of the PICO question, development of the systematic review, and drafting the recommendations based on the voting by the panel members.
We have not conducted formal analysis of WP1, which will be done in RP3. As mentioned in the technical report, we plan to include additional 110,304 patients in the last two years of our project, which will give us the answer to the most important question, namely "Does the use of AI in colonoscpy reduce colorectal cancer and death?". On the other hand, results from WP4 and WP5 should have decent impact on the science and society since we published the first position statement on ethical and legal concerns on AI in gastroenterology in Annals of Internal Medicine in WP4 and the first guidelines on AI in colonoscopy in BMJ. Both journals have decent influence on daily practice, future research, and policy making, with a potential of changing the standard of care.