NCT06116396

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
29mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Sep 2020Sep 2028

Study Start

First participant enrolled

September 29, 2020

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

October 30, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2025

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2028

Expected
Last Updated

November 7, 2023

Status Verified

November 1, 2023

Enrollment Period

5 years

First QC Date

October 30, 2023

Last Update Submit

November 6, 2023

Conditions

Urothelial Carcinoma

Outcome Measures

Primary Outcomes (1)

  • Prognostic role of the liquid biopsy

    Gene signature in CTC and UTC predicting tumor relapse

    2020-2023

Study Arms (2)

1

Urothelial neoplasia

Genetic: Genetic analysis on isolated cells

2

Age-matched individuals free of neoplasia

Genetic: Genetic analysis on isolated cells

Interventions

Genetic analysis on isolated cellsGENETIC

Isolation of cells from blood and urine

12

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults men and women.

You may qualify if:

  • Diagnosis of urothelial neoplasia, naive for therapy

You may not qualify if:

  • Absence of previous neolpastic disease or genetic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology Department

Milan, 20132, Italy

RECRUITING

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

CarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Study Officials

  • Massimo Alfano, PhD

    IRCCS Ospedale San Raffaele

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Massimo Alfano, PhD

CONTACT

+39022643alfano.massimo@hsr.it

Chiara Venegoni, Dr.

CONTACT

+39022643venegoni.chiara@hsr.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

October 30, 2023

First Posted

November 3, 2023

Study Start

September 29, 2020

Primary Completion

September 29, 2025

Study Completion (Estimated)

September 29, 2028

Last Updated

November 7, 2023

Record last verified: 2023-11

Locations

IT(1)