NCT06116396

Liquid Biospy for Urinary Cancers

Use of Urinary Tumor Cells and Circulating Tumor Cells (CTCs) in the Prognosis and Therapy of Patients With Bladder (BCa) and Upper Urinary Tract (UTUC) Cancer"

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: All
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

The project aims to characterize the prognostic role of CTCs in Bladder cancer patients, with the specific aims to better stratify patients with non-muscle invasive bladder cancer at the first transurethral resection of tumor and to identify urothelial biomarker expressed by CTCs.

Detailed description

Bladder cancer (BCa) is the 9th most common cancer worldwide, with an estimated prevalence of around 2.7 million cases and an incidence around 350.000 new cases/year. The proper management of BCa remains an unmet clinical need, because one of the main problems in BCa treatment is the inability to efficaciously prevent high-grade non-muscle invasive bladder cancer (NMIBC) relapse and progression, which occur in 80% and 45% of patients respectively. Indeed, as a consequence of the lack of efficient established prognostic, diagnostic and predictive biomarker of high-risk NMIBC, Bca patients undergo multiple treatments and cystoscopic assessments along their life, with consequent poor quality of life and high healthcare costs. Circulating Tumor Cells (CTCs) in blood represent an invaluable source of tumor material that can be easily collected yhrough a simple blood draw and may represent the clonal component of the primary tumor that left the primary site. For this reason, the aim of this study is to characterize the prognostic role of CTCs in Bladder cancer patients, with the specific aims to better stratify patients with non-muscle invasive bladder cancer at the first transurethral resection of tumor and to identify urothelial biomarker expressed by CTCs.

Conditions

• Urothelial Carcinoma

Interventions

Type	Name	Description
GENETIC	Genetic analysis on isolated cells	Isolation of cells from blood and urine

Timeline

• Start date: 2020-09-29
• Primary completion: 2025-09-29
• Completion: 2028-09-29
• First posted: 2023-11-03
• Last updated: 2023-11-07

Locations

1 site across 1 country: Italy