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CIRCE: Liquid Biospy for Urinary Cancers

Sponsor
IRCCS San Raffaele (Other)
Overall Status
Recruiting
CT.gov ID
NCT06116396
Collaborator
(none)
450
Enrollment
1
Location
96
Anticipated Duration (Months)
4.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Genetic: Genetic analysis on isolated cells

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 Design

Study Type:
Observational
Anticipated Enrollment :
450 participants
Observational Model:
Case-Control
Time Perspective:
Other
Official 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"
Actual Study Start Date :
Sep 29, 2020
Anticipated Primary Completion Date :
Sep 29, 2025
Anticipated Study Completion Date :
Sep 29, 2028

Arms and Interventions

Arm Intervention/Treatment
1

Urothelial neoplasia

Genetic: Genetic analysis on isolated cells
Isolation of cells from blood and urine
2

Age-matched individuals free of neoplasia

Genetic: Genetic analysis on isolated cells
Isolation of cells from blood and urine

Outcome Measures

Primary Outcome Measures

  1. Prognostic role of the liquid biopsy [2020-2023]

    Gene signature in CTC and UTC predicting tumor relapse

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Diagnosis of urothelial neoplasia, naive for therapy

Exclusion Criteria:

Absence of previous neolpastic disease or genetic diseases

Contacts and Locations

Locations

Site City State Country Postal Code
1 Urology Department Milan Italy 20132

Sponsors and Collaborators

  • IRCCS San Raffaele

Investigators

  • Principal Investigator: Massimo Alfano, PhD, IRCCS Ospedale San Raffaele

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Massimo Alfano, PhD, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT06116396
Other Study ID Numbers:
  • CIRCE
First Posted:
Nov 3, 2023
Last Update Posted:
Nov 7, 2023
Last Verified:
Nov 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Carcinoma, Transitional Cell

Study Results

No Results Posted as of Nov 7, 2023