HER2 and LA/mUC: A Multi-country Chart Review Cohort Study

a study on Transitional Cell Carcinoma HER2

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine UCSF
Dates
study started
completion around
Principal Investigator
by Nataliya Mar (uci)Vadim Koshkin (ucsf)
Headshot of Vadim Koshkin
Vadim Koshkin

Description

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).

Official Title

A Retrospective Chart Review of Real-world Treatment Outcomes in Patients With Locally Advanced Unresectable or Metastatic Urothelial Cancer Based on HER2 Expression

Keywords

Urothelial Carcinoma, Urothelial Cancer, Bladder Cancer, HER2 Mutations, HER2 Overexpression, HER2 Amplification, Seattle Genetics, Transitional Cell Carcinoma

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • University of California Irvine accepting new patients
    Orange California 92868 United States
  • University of California San Francisco accepting new patients
    San Francisco California 94158 United States

Lead Scientists at University of California Health

  • Nataliya Mar (uci)
    Associate Clinical Professor, Medicine, School of Medicine. Authored (or co-authored) 31 research publications
  • Vadim Koshkin (ucsf)
    I am a genitourinary medical oncologist and in this capacity I specialize in caring for patients with bladder, prostate, kidney and testicular cancers.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Seagen Inc.
ID
NCT05902494
Study Type
Observational
Participants
Expecting 350 study participants
Last Updated