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Prevalence of PD-L1 Expression in Patients With Advanced Urothelial Carcinoma

CompletedN/A

Sponsor: AstraZeneca

Conditions: Urothelial Carcinoma

Countries: United States

The purpose of this study is to assess the prevalence of pre-treatment tumor tissue PD-L1 expression in patients diagnosed with advanced urothelial carcinoma.

Eligibility overview

Sex: ALL

Age: 18 Years to 130 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Provision of written informed consent
* Age ≥18 years old
* Patient must have advanced UC confirmed by their HCP; histologically- confirmed diagnosis of UC an dHCP-confirmed advanced UC.
* Patient must be either currently receiving 1L systemic treatment for their advanced UC or will be starting 1L systemic treatment (i.e. "newly diagnosed" advanced UC; 1L therapy is defined as the first systemic therapy given for advanced UC).
* Patient remains eligible for the study if they received neoadjuvant or adjuvant platinum-based chemotherapy if their recurrence was more than 12 months after their last chemotherapy dose.
* Radio-sensitizing chemotherapy as part of chemoradiation is NOT counted as neoadjuvant or adjuvant chemotherapy; thus, the 12-month interval mention above does not apply, and the patient would be eligible
* Patients with available tumor tissue sample (fresh or archival - up to 3 years old) that was collected as part of SoC any time prior to 1L treatment for advanced UC with a target of 18 slides (7 minimum) available for biomarker testing (PD-L1 and tTMB). Already prepared slides must have been cut within 6 months prior to PD-L1 testing.

Exclusion Criteria:

* Patients concurrently enrolled in other clinical trials that prohibit their participation in a non-interventional study
* Patient has resectable localized UC and has refused surgery
* Patients with history of non-urothelial active malignancy that completed therapy within 2 years from study enrollment except:

  * Any resected in situ carcinoma or non-melanoma skin cancer
  * Localized (early stage) cancer treated with curative intent (without evidence of recurrence and intent for further therapy) and in which no systemic therapy was indicated

Locations (58)

Little Rock, Arkansas, United States
Glendale, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Monterey, California, United States
Santa Rosa, California, United States
Denver, Colorado, United States
Englewood, Colorado, United States
Hartford, Connecticut, United States
Stamford, Connecticut, United States
Boca Raton, Florida, United States
Hialeah, Florida, United States
Jacksonville, Florida, United States
Augusta, Georgia, United States
Roswell, Georgia, United States
Geneva, Illinois, United States
Harvey, Illinois, United States
Lake Barrington, Illinois, United States
Naperville, Illinois, United States
Greenwood, Indiana, United States
Lafayette, Indiana, United States
Muncie, Indiana, United States
Cedar Rapids, Iowa, United States
Waterloo, Iowa, United States
Kansas City, Kansas, United States
Wichita, Kansas, United States
Baton Rouge, Louisiana, United States
Shreveport, Louisiana, United States
Brewer, Maine, United States
Lewiston, Maine, United States
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