To hear about similar clinical trials, please enter your email below
Trial Title:
HER2 and LA/mUC: A Multi-country Chart Review Cohort Study
NCT ID:
NCT05902494
Condition:
Urothelial Carcinoma
Conditions: Official terms:
Carcinoma, Transitional Cell
Conditions: Keywords:
Urothelial Cancer
Bladder Cancer
HER2 Mutations
HER2 Overexpression
HER2 Amplification
Seattle Genetics
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Retrospective
Summary:
This study is being done to learn about urothelial cancers that make HER2 and how that
affects treatment choices for participants with urothelial cancer. During this study, the
medical and health records of participants will be reviewed to learn more about their
health.
Participants will have urothelial cancer that has grown in the body near where it started
(locally advanced) and cannot be removed (unresectable) or has spread through the body
(metastatic).
Criteria for eligibility:
Study pop:
Adults from US and European participating hospitals and physicians' practices with
histologically confirmed LA/mUC who initiated therapy after prior progression on
platinum-based therapy with or without maintenance avelumab.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Histologically confirmed UC originating from the renal pelvis, ureters, bladder, or
urethra. Mixed-cell type tumors are eligible as long as urothelial cell carcinoma is
the predominant cell type.
- Locally advanced unresectable or metastatic stage disease
- Formalin fixed paraffin embedded (FFPE) tumor tissue blocks (or freshly sectioned
slides, see laboratory manual for details) available for HER2 testing.
- At least 1 prior line of systemic therapy for locally advanced unresectable or
metastatic urothelial carcinoma (LA/mUC), including 1 line of platinum-containing
chemotherapy.
- Initiation of anticancer therapy for UC after prior progression on platinum-based
therapy with or without maintenance avelumab between 01 January 2019 and 12 months
before the end of data collection
- Radiographically documented and measurable disease progression immediately before
index date
Exclusion Criteria:
- Any concurrent malignant neoplasm requiring systemic therapy during the study window
- Enrollment in a therapeutic clinical trial and received non-standard of care
treatment during index line of therapy
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Locations:
Facility:
Name:
University of California Irvine
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Nataliya Mar
Email:
Principal Investigator
Facility:
Name:
University of California San Francisco
Address:
City:
San Francisco
Zip:
94158
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Vadim Koshkin
Email:
Principal Investigator
Facility:
Name:
University of Colorado
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Laura Graham
Email:
Principal Investigator
Facility:
Name:
Avera
Address:
City:
Sioux Falls
Zip:
57105
Country:
United States
Status:
Recruiting
Investigator:
Last name:
Casey Williams
Email:
Principal Investigator
Facility:
Name:
Hospital Center University De Rouen
Address:
City:
Rouen
Zip:
76000
Country:
France
Status:
Recruiting
Investigator:
Last name:
Christian Pfister
Email:
Principal Investigator
Start date:
June 29, 2023
Completion date:
September 30, 2025
Lead sponsor:
Agency:
Seagen Inc.
Agency class:
Industry
Source:
Seagen Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05902494
