Biliary tract cancer Cancer of the biliary tract
Conditions
Sponsors
Ventana Medical System, Inc. (Roche Tissue Diagnostics)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Samples inclusion criteria:It must be an FFPE biliary tract cancer tumor specimen submitted under informed consent for patient enrollment into ARTEMIDE-Biliary02 Study and processed in accordance with standard practice;It must contain sufficient tumor tissue for interpretation at the discretion of the reviewing pathologist;It must be an FFPE tumor tissue block processed in accordance with standard practice or unstained FFPE slides, if a block is unavailable.
Exclusion criteria
Exclusion criteria: Samples exclusion criteria:It is a fine needle aspirate or a cytology specimen;It consists of tissue containing bone that has been decalcified;*It is known to be fixed in 95% alcohol, alcohol-formalin-acetic acid (AFA) or PREFER™; andCut slides were prepared and stained outside the 7-month cut slide stability window. * Prior to testing of any bone specimen, evidence of decalcification must be obtained. This information may be obtained from the pathology report. If the pathology report does not specify whether the sample was decalcified or not, the sample must be held and the submitting site queried as to whether the sample has been decalcified. If the sample has been decalcified, testing cannot proceed.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint for the Dx study is the primary efficacy endpoint defined in Study ARTEMIDE-Biliary02: • Overall Survival (OS), as defined as time from randomization until the date of death due to any cause. The analysis will include all randomized participants in the PD-L1 =1% population. All deaths will be included, regardless of whether the participant withdraws from therapy or receives another anticancer therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| The final staining acceptability rate will be evaluated among all specimens that have been tested with VENTANA PD-L1 (SP263) CDx Assay for the purpose of patient screening in AstraZeneca Study D702NC00001. | — |
Countries
Australia, Belgium, Brazil, Canada, China, France, Germany, India, Italy, Japan, Netherlands, Poland, South Korea, Spain, Taiwan, Thailand, Turkey, United Kingdom, United States
Contacts
Public ContactW. Go
Ventana Medical System, Inc. (Roche Tissue Diagnostics)
Outcome results
None listed