Liquid Biospy for Urinary Cancers

Recruiting

• Conditions: Urothelial Carcinoma
• Interventions: Genetic: Genetic analysis on isolated cells

• Registration Number: NCT06116396
• Lead Sponsor: IRCCS San Raffaele

Brief 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.

Study Timeline

• Study Start: 2020-09-29
• Study First Submitted: 2023-10-30
• Study First Submitted QC: 2023-10-30
• Status Verified: 2023-11
• Study First Posted: 2023-11-03
• Last Update Submitted: 2023-11-06
• Last Update Posted: 2023-11-07
• Primary Completion: 2025-09-29
• Study Completion: 2028-09-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

Diagnosis of urothelial neoplasia, naive for therapy

Exclusion Criteria

Absence of previous neolpastic disease or genetic diseases

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Genetic analysis on isolated cells	Urothelial neoplasia
2	Genetic analysis on isolated cells	Age-matched individuals free of neoplasia

Primary Outcome Measures

Name	Time	Method
Prognostic role of the liquid biopsy	2020-2023	Gene signature in CTC and UTC predicting tumor relapse

Trial Locations

Locations (1)

Urology Department; 🇮🇹 Milan, Italy