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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06116396
Acronym
CIRCE
Enrollment
450
Registered
2023-11-03
Start date
2020-09-29
Completion date
2028-09-29
Last updated
2023-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urothelial Carcinoma

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.

Interventions

GENETICGenetic analysis on isolated cells

Isolation of cells from blood and urine

Sponsors

IRCCS San Raffaele
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Diagnosis of urothelial neoplasia, naive for therapy

Exclusion criteria

Absence of previous neolpastic disease or genetic diseases

Design outcomes

Primary

MeasureTime frameDescription
Prognostic role of the liquid biopsy2020-2023Gene signature in CTC and UTC predicting tumor relapse

Countries

Italy

Contacts

Primary ContactMassimo Alfano, PhD
alfano.massimo@hsr.it+39022643
Backup ContactChiara Venegoni, Dr.
venegoni.chiara@hsr.it+39022643

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026