Liquid Biospy for Urinary Cancers (CIRCE)
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"
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Massimo Alfano, PhD
- Phone Number: 6351 +39022643
- Email: alfano.massimo@hsr.it
Study Contact Backup
- Name: Chiara Venegoni, Dr.
- Phone Number: 5431 +39022643
- Email: venegoni.chiara@hsr.it
Study Locations
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Milan, Italy, 20132
- Recruiting
- Urology Department
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Contact:
- Andrea Salonia, MD, PhD
- Phone Number: 5661 +39022643
- Email: salonia.andrea@hsr.it
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
Diagnosis of urothelial neoplasia, naive for therapy
Exclusion Criteria:
Absence of previous neolpastic disease or genetic diseases
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
1
Urothelial neoplasia
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Isolation of cells from blood and urine
|
|
2
Age-matched individuals free of neoplasia
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Isolation of cells from blood and urine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Prognostic role of the liquid biopsy
Time Frame: 2020-2023
|
Gene signature in CTC and UTC predicting tumor relapse
|
2020-2023
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Massimo Alfano, PhD, IRCCS Ospedale San Raffaele
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIRCE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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