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Trial Title:
Liquid Biospy for Urinary Cancers
NCT ID:
NCT06116396
Condition:
Urothelial Carcinoma
Conditions: Official terms:
Carcinoma, Transitional Cell
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Genetic
Intervention name:
Genetic analysis on isolated cells
Description:
Isolation of cells from blood and urine
Arm group label:
1
Arm group label:
2
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.
Criteria for eligibility:
Study pop:
Adults men and women.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
Diagnosis of urothelial neoplasia, naive for therapy
Exclusion Criteria:
Absence of previous neolpastic disease or genetic diseases
Gender:
All
Minimum age:
40 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Urology Department
Address:
City:
Milan
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Andrea Salonia, MD, PhD
Phone:
+39022643
Phone ext:
5661
Email:
salonia.andrea@hsr.it
Start date:
September 29, 2020
Completion date:
September 29, 2028
Lead sponsor:
Agency:
IRCCS San Raffaele
Agency class:
Other
Source:
IRCCS San Raffaele
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06116396
