NCT05902494Completed
HER2 and LA/mUC: A Multi-country Chart Review Cohort Study
A Retrospective Chart Review of Real-world Treatment Outcomes in Patients With Locally Advanced Unresectable or Metastatic Urothelial Cancer Based on HER2 Expression
Source: ClinicalTrials.gov · Last updated 20 Jul 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 389 (actual)
- First submitted
- 5 Jun 2023
- Start date
- 29 Jun 2023
- Primary completion date
- 18 Jun 2025
- Lead sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Diseases
- Bladder cancer
- NCT number
- NCT05902494
What you commit to
- Study type: Observational
- Participants enrolled: 389
- From 29 Jun 2023 to the primary completion date, 18 Jun 2025
- 23 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (23)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Akh Wien Coordinator of this site? Confirm its status | Vienna | Austria | Unknown status |
| Alexianer Krefeld GmbH Coordinator of this site? Confirm its status | Krefeld | Germany | Unknown status |
| University Hospital Lübeck Coordinator of this site? Confirm its status | Lübeck | Germany | Unknown status |
| Stuttgart Hospital Coordinator of this site? Confirm its status | Stuttgart | Germany | Unknown status |
| CHU Bordeaux Hopital Saint Andre Coordinator of this site? Confirm its status | Bordeaux | France | Unknown status |
| Centre Hospitalier Départemental Les Oudairies Coordinator of this site? Confirm its status | La Roche-sur-Yon | France | Unknown status |
| Centre Leon Berard Coordinator of this site? Confirm its status | Lyon | France | Unknown status |
| Centre Antoine Lacassagne Coordinator of this site? Confirm its status | Nice | France | Unknown status |
| Institut Mutualiste Montsouris Coordinator of this site? Confirm its status | Paris | France | Unknown status |
| CHU LYON Coordinator of this site? Confirm its status | Pierre-Bénite | France | Unknown status |
| CHU de Rouen Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
| Foch Hospital Coordinator of this site? Confirm its status | Suresnes | France | Unknown status |
| University of Colorado Hospital Coordinator of this site? Confirm its status | Aurora | United States | Unknown status |
| Levine Cancer Institute Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Duke Cancer Institute - School of Medicine Coordinator of this site? Confirm its status | Durham | United States | Unknown status |
| Vanderbilt-Ingram Cancer Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of California Irvine Coordinator of this site? Confirm its status | Orange | United States | Unknown status |
| Stanford Cancer Institute - School of Medicine Coordinator of this site? Confirm its status | Palo Alto | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| University of California, Los Angeles Coordinator of this site? Confirm its status | Santa Monica | United States | Unknown status |
| Avera Cancer Institute Center Coordinator of this site? Confirm its status | Sioux Falls | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.