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NCT06041945: SAVE
Artificial Intelligence to Implement Cost-saving Strategies for Colonoscopy Screening Based on in Vivo Prediction of Polyp Histology
NA trial testing Standard, high-definition colonoscopy with the use of CADe assistance in Colonic Neoplasms in 1,800 participants. Currently enrolling.
1 September 2027
Quick facts
| Lead sponsor | Istituto Clinico Humanitas |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 1,800 |
| Start date | 21 September 2023 |
| Primary completion | 1 September 2027 |
| Estimated completion | 1 September 2027 |
| Sites | 2 locations across Italy |
Drugs / interventions 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
Conditions studied
- Colonic Neoplasms — all drugs for Colonic Neoplasms →
Sponsor
Istituto Clinico Humanitas
Who can join
40 and older, any sex, with Colonic Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06041945
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06041945 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Istituto Clinico Humanitas
- Last refreshed: 4 October 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06041945.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing