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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06116396
Other study ID # CIRCE
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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