Liquid Biospy for Urinary Cancers

NCT ID: NCT06116396

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-29

Study Completion Date

2028-09-29

Brief Summary

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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

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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.

Conditions

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Urothelial Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

OTHER

Study Groups

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1

Urothelial neoplasia

Genetic analysis on isolated cells

Intervention Type GENETIC

Isolation of cells from blood and urine

2

Age-matched individuals free of neoplasia

Genetic analysis on isolated cells

Intervention Type GENETIC

Isolation of cells from blood and urine

Interventions

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Genetic analysis on isolated cells

Isolation of cells from blood and urine

Intervention Type GENETIC

Eligibility Criteria

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Inclusion Criteria

Diagnosis of urothelial neoplasia, naive for therapy

Exclusion Criteria

Absence of previous neolpastic disease or genetic diseases
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IRCCS San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Massimo Alfano

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Massimo Alfano, PhD

Role: PRINCIPAL_INVESTIGATOR

IRCCS Ospedale San Raffaele

Locations

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Urology Department

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Massimo Alfano, PhD

Role: CONTACT

+39022643 ext. 6351

Chiara Venegoni, Dr.

Role: CONTACT

+39022643 ext. 5431

Facility Contacts

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Andrea Salonia, MD, PhD

Role: primary

+39022643 ext. 5661

Other Identifiers

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CIRCE

Identifier Type: -

Identifier Source: org_study_id

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