COMPLETED

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

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Conditions

Urothelial CarcinomaUrothelial CancerBladder CancerHER2 MutationsHER2 OverexpressionHER2 AmplificationSeattle Genetics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2023-06-29
Study Completion:2025-06-18
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05902494

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * Locally advanced unresectable or metastatic stage disease
  3. * Formalin fixed paraffin embedded (FFPE) tumor tissue blocks (or freshly sectioned slides, see laboratory manual for details) available for HER2 testing.
  4. * 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.
  5. * 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
  6. * Radiographically documented and measurable disease progression immediately before index date
  1. * Any concurrent malignant neoplasm requiring systemic therapy during the study window
  2. * Enrollment in a therapeutic clinical trial and received non-standard of care treatment during index line of therapy

Contacts and Locations

Principal Investigator

Pfizer CT.gov Call Center
STUDY_DIRECTOR
Pfizer

Study Locations (Sites)

Mayo Clinic
Phoenix, Arizona, 85054
United States
University of California Irvine
Orange, California, 92868
United States
Stanford Cancer Institute - School of Medicine
Palo Alto, California, 94394
United States
University of California San Francisco
San Francisco, California, 94143
United States
University of California Los Angeles
Santa Monica, California, 90404
United States
University of Colorado Hospital
Aurora, Colorado, 80045
United States
ICAHN School of Medicine at Mount Sinai,
New York, New York, 10029
United States
Levine Cancer Institute
Charlotte, North Carolina, 28204
United States
Duke Cancer Institute - School of Medicine
Durham, North Carolina, 27710
United States
Avera Cancer Institute Center
Sioux Falls, South Dakota, 57104
United States
Vanderbilt - Ingram Cancer Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

  • Pfizer CT.gov Call Center, STUDY_DIRECTOR, Pfizer

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-29
Study Completion Date2025-06-18

Study Record Updates

Study Start Date2023-06-29
Study Completion Date2025-06-18

Terms related to this study

Keywords Provided by Researchers

  • Urothelial Cancer
  • Bladder Cancer
  • HER2 Mutations
  • HER2 Overexpression
  • HER2 Amplification
  • Seattle Genetics

Additional Relevant MeSH Terms

  • Urothelial Carcinoma