Liquid Biospy for Urinary Cancers

Urothelial Carcinoma Clinical Trial

— CIRCE  

Official title:

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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06116396
• Other study ID #: CIRCE
• Status: Recruiting
• Start date: September 29, 2020
• Est. completion date: September 29, 2028

Study information

• Verified date: November 2023
• Source: IRCCS San Raffaele
• Contact: Massimo Alfano, PhD
• Phone: +39022643
• Email: alfano.massimo[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: September 29, 2028
• Est. primary completion date: September 29, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

Diagnosis of urothelial neoplasia, naive for therapy

Exclusion Criteria:

Absence of previous neolpastic disease or genetic diseases

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Genetic:
• Genetic analysis on isolated cells
Isolation of cells from blood and urine

Locations

Country	Name	City	State
Italy	Urology Department	Milan

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prognostic role of the liquid biopsy	Gene signature in CTC and UTC predicting tumor relapse	2020-2023