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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

Circulating Tumor cells in urothelial cancer patients relapsing after or refractory to platinum based first line chemotherapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-000124-34-AT
Enrollment
Unknown
Registered
2013-03-01
Start date
2013-03-27
Completion date
Unknown
Last updated
2015-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Circulating tumor cells in urothelial cancer patients relapsing after or refractory to platinum based first line chemotherapy

Interventions

Product Name: Platinum based chemotherapy Pharmaceutical Form: Infusion

Sponsors

PD Dr. Maria De Santis
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Patient of childbearing potential (female patients only)

Design outcomes

Primary

MeasureTime frame
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 - 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 - Correlation of CTC presence and percentage with the published clinical prognostic factors (Bellmunt);Primary end point(s): The following biomarkers will be evaluated: - Circulating tumor cells (CTC) - HER-2 positivity of detected CTCs - HER-2 positivity of tumor tissue;Timepoint(s) of evaluation of this end point: Blood sample examination for CTCs and HER-2 Analysis of tumor block slides—

Secondary

MeasureTime frame
Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable—

Countries

Austria

Contacts

Public ContactCoordinating Investigator

PD Dr. Maria De Santis

maria.desantis@wienkav.at004301601912324

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Mar 1, 2026