Colonic NeoplasmsSAVENCT06041945
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
A study testing Standard, high-definition colonoscopy with the use of CADe assistance, Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ and Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ in people with Colonic Neoplasms, run by Istituto Clinico Humanitas at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Neoplasms
- What is being tested?
- Standard, high-definition colonoscopy with the use of CADe assistance, Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ and Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 2 sitesItaly
- Study dates
- 21 Sep 2023to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All >40 years-old patients undergoing colonoscopy for selected indications
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milano, 20089
- Recruiting
Istituto Clinico Humanitas
Rozzano, Milano, 20089
Cesare Hassan, Prof/MD, 0039-02-82247385, cesare.hassan@hunimed.eu
Cesare Hassan
About this study
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
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.
- Conditions
- Colonic Neoplasms
- Being tested
- Standard, high-definition colonoscopy with the use of CADe assistance, Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ, Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard, high-definition colonoscopy with the use of CADe assistanceDevice
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-situDevice
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-situDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Arm CADe | Active comparator | Standard, high-definition colonoscopy with the use of CADe assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology. Receives: Device: Standard, high-definition colonoscopy with the use of CADe assistance |
| Standard Arm CADe/CADx | Active comparator | Standard, high-definition colonoscopy with the use of CADe/CADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology. Receives: Device: Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ |
| Leave-In-Situ Arm | Experimental | Standard, high-definition colonoscopy with the use of CADe/CADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION, NEC).
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. Receives: Device: Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (3)
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.
Measured: 4 years
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
Measured: 4 years
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
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start21 Sep 2023
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colonic NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041945
- Sponsor's protocol ID
- 3483 - SAVE
- Acronym
- SAVE
- Status last verified
- Sep 2023
- First submitted
- 4 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06041945
- Acronym / sponsor ID
- SAVE / 3483 - SAVE
- Conditions
- Colonic Neoplasms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 21 Sep 2023 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 18 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Arm CADe | Active comparator | Device: Standard, high-definition colonoscopy with the use of CADe assistanceStandard, high-definition colonoscopy with the use of CADe assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology. |
| Standard Arm CADe/CADx | Active comparator | Device: Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situStandard, high-definition colonoscopy with the use of CADe/CADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION ,NEC). All detected polyps regardless of size and optical diagnosis will be resected and sent to pathology. |
| Leave-In-Situ Arm | Experimental | Device: Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situStandard, high-definition colonoscopy with the use of CADe/CADx assistance (GI-GENIUS, Medtronic; CAD-EYE, Fujifilm; WISE VISION, NEC). 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All >40 years-old patients undergoing colonoscopy for selected indications
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard, high-definition colonoscopy with the use of CADe assistanceAll detected polyps regardless of size and optical diagnosis will be resected and sent to pathology. | Device | Standard Arm CADe |
| Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situAll detected polyps regardless of size and optical diagnosis will be resected and sent to pathology. | Device | Standard Arm CADe/CADx |
| Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situPolyps 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. | Device | Leave-In-Situ Arm |
Primary outcome
Non-inferiority in Adenoma Detection Rate
Time frame: 4 years
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.
3 secondary outcomes
Negative Predictive Value for colorectal neoplasia
Time frame: 4 years
Concordance between post-polypectomy surveillance and when adopting a leave-in-situ strategy
Time frame: 4 years
Change in the cost of polypectomy and histology in screening programs
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard, high-definition colonoscopy with the use of CADe assistance, Standard, high-definition colonoscopy with the use of CADe/CADx assistance, no leave-in-situ and Standard, high-definition colonoscopy with the use of CADe/CADx assistance, leave-in-situ in people with Colonic Neoplasms, run by Istituto Clinico Humanitas at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cesare Hassan (02-82247385, cesare.hassan@hunimed.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Non-inferiority in Adenoma Detection Rate (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2023.