Last reviewed · How we verify
NCT05500248
Artificial Intelligence for Leaving in Situ Colorectal Polyps.
NA trial testing Leave In Situ in Colonic Neoplasms in 919 participants. Completed in 30 August 2024.
31 December 2023
Quick facts
| Lead sponsor | University of Roma La Sapienza |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | prevention |
| Enrollment | 919 |
| Start date | 1 October 2022 |
| Primary completion | 31 December 2023 |
| Estimated completion | 30 August 2024 |
| Sites | 1 location across Italy |
Drugs / interventions tested
- Leave In Situ
- Standard
Conditions studied
- Colonic Neoplasms — all drugs for Colonic Neoplasms →
Sponsor
University of Roma La Sapienza
Who can join
18 and older, any sex, with Colonic Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This two parallel-arms, randomized, multicenter trial is aimed at investigating safety and effectiveness of a Computer-Aided-Diagnosis (CADx)-assisted leave-in-situ strategy (Leave-In-Situ Arm) as opposed to a resect-all strategy (Standard Arm) as implemented by endoscopists in a real-world setting. With this study it will be possible to understand the impact of CADx in patient treatment and management both in terms of clinical outcome and costs.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Safety of artificial intelligence-assisted optical diagnosis for leaving colorectal polyps in situ during colonoscopy (PRACTICE): a non-inferiority, randomised controlled trial.
Antonelli G, Desideri F, Scarozza P, Andrisani G, et al · · 2025 · PMID 40914178 · DOI 10.1016/s2468-1253(25)00140-2
Verify or expand the search:
- PubMed search for NCT05500248
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Colonic Neoplasms
Currently open trials in the same condition.
- NCT07173985 — Strategies for Optimizing a Mailed FIT Program in Appalachia · NA · recruiting
- NCT06885697 — Anti-Mesothelin TNaive/SCM hYP218 (TNhYP218) CAR T Cells in Participants With Mesothelin-Expressing Solid Tumors Includi · Phase 1 · recruiting
- NCT06371898 — Comparison of MORbidity of Submucosal DIssection Resection of Giant cOlon Lesions Versus Surgery: a National Multicenter · active not recruiting
- NCT06119867 — CompariSon Between the EuroPeAn and Japanese pathologiCal InvEstigation for Colon Cancer (SPACE) · Phase 3 · recruiting
- NCT06124378 — Neoadjuvant Tislelizumab With Chemotherapy for the Treatment of MSS Colon Cancer · Phase 2 · active not recruiting
Other University of Roma La Sapienza trials
Trials by the same sponsor.
- NCT07485023 — Oral Versus Intravenous Iron for Anemia Diagnosed After 34 Weeks of Gestation · NA · not yet recruiting
- NCT07305519 — The Combined Effect of Magnesium, Palmitoylethanolamide, High-Molecular-weight Hyaluronic Acid, Vitamin B6, and Vitamin · NA · not yet recruiting
- NCT07520968 — ABX Versus CHX in NSPT: a RCT · NA · active not recruiting
- NCT07109596 — Integration of Clinical, Biological and Psycho-social Variables for a Gender-sensitive Frailty Prediction · recruiting
- NCT07490574 — Trial of Underwater Versus Gas-Insufflation Colorectal Endoscopic Submucosal DisseEtion · NA · completed
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 NCT05500248 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Roma La Sapienza
- Last refreshed: 18 April 2025
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/NCT05500248.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing