N/a bladder cancer
Conditions
Interventions
 
oncoReveal® Essential+ Panel 
Sponsors
Cellcarta
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Tumor biomarkers will be measured from excess tissue collected from the TURBT or bladder screening biopsy samples sent for central review, when available. No dedicated biomarker tissue samples will be collected from participants. FFPE tumor tissue sample collected prior to signing of informed consent is required for biomarker eligibility. A representative FFPE sample in a tissue block or at least 5 unstained slides (non-paraffin dipped, 5µm), must be submitted. Tumor tissue should be of good quality and contain viable tumor cells that preserves cellular context and tissue architecture.
Exclusion criteria
Exclusion criteria: Fine-needle aspiration (FNA), brushing, cell pellets, decalcified samples and lavage are not acceptable.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ability to yield robust and reliable results when used as intended in the intended setting, and by intended users | — |
Secondary
| Measure | Time frame |
|---|---|
| Number/proportion of clinical samples that were deemed not of suitable quality for analysis (e.g., when compared to predefined criteria, or when compared to quality check). Number/proportion of “no results”from analysis of clinical samples. Number/proportion of re-runs of clinical samples required and the cause of the re-runs (e.g., failed controls, no results). Number/proportion of new and additional clinical samples required (i.e., the first sample could not be used due to observed insufficient quality or failed to generate results or other reason). Number/proportion of failed positive/negative controls. Number/proportion of control re-runs. Number/proportion of results that were delivered within the stipulated time frame. | — |
Countries
Argentina, Belgium, Brazil, France, Germany, Greece, Israel, Italy, Japan, Netherlands, South Korea, Spain, United Kingdom, United States
Contacts
Public ContactPS Swatkowski
Cellcarta
Outcome results
None listed