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Recruiting

NCT Number: NCT06116396

Liquid Biospy for Urinary Cancers

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.

Recruiting

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Urology Department

Milan, 20132, Italy

Location status: Recruiting

Location contact

Andrea Salonia, MD, PhD

CONTACT

[email protected]

+39022643 ext. 5661

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of urothelial neoplasia, naive for therapy

Exclusion criteria

Absence of previous neolpastic disease or genetic diseases

Treatment and study plan

Genetic analysis on isolated cells

Genetic

Isolation of cells from blood and urine

Primary outcomes

  1. Prognostic role of the liquid biopsy

    Time frame: 2020-2023

    Gene signature in CTC and UTC predicting tumor relapse

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Venegoni, Dr.

CONTACT

[email protected]

+39022643 ext. 5431

Massimo Alfano, PhD

CONTACT

[email protected]

+39022643 ext. 6351

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

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"

Acronym: CIRCE

Important dates

Study start
2020
Primary completion
2025
Study completion
2028
First posted
Nov 3, 2023
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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