Evaluation if and how many circulating tumor cells can be found in the blood of patients with urothelial cancer who have been treated with platinum based chemotherapy

Conditions: Circulating tumor cells in urothelial cancer patients relapsing after or refractory to platinum based first line chemotherapy
Therapeutic area: Diseases [C] - Cancer [C04]

Registration Number: EUCTR2013-000124-34-AT

Lead Sponsor: PD Dr. Maria De Santis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Written informed consent
- Male or female patient with urothelial cancer aged = 18 years
- Patient progressing during or after platinum containing combination chemotherapy or within 12 months after platinum containing chemotherapy in the perioperative setting
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 35
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 35

Exclusion Criteria

Patient of childbearing potential (female patients only)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the presence and number of biomarkers (CTC and HER-2 positivity of detected CTCs) in urothelial cancer patients who have progressed after platinum combination chemoterapy or who are platinum refractory;Secondary Objective: - Exploratory analysis of outcome parameters, to create a hypothesis about the potential value of CTC levels in the prognosis<br>- Investigating the presence and the cut-off-level of circulating tumor cells (CTCs) and HER-2 positive CTCs in patients with UC after platinum based combination chemotherapy<br>- Correlation of CTC presence and percentage with the published clinical prognostic factors (Bellmunt);Primary end point(s): The following biomarkers will be evaluated:<br>- Circulating tumor cells (CTC)<br>- HER-2 positivity of detected CTCs<br>- HER-2 positivity of tumor tissue;Timepoint(s) of evaluation of this end point: Blood sample examination for CTCs and HER-2<br>Analysis of tumor block slides

Secondary Outcome Measures