Urothelial Cancer - Genomic Analysis to Improve Patient Outcomes and Research (UC-GENOME): A Bladder Cancer Advocacy Network (BCAN)-Led Collaborative Research Pilot Study

UC-GENOME is a real-world cohort of patients with metastatic urothelial carcinoma (UC). The study consisted of two co-equal aims: 1) to provide targeted DNA sequencing for clinical decision making at no cost to patients; and 2) to create a resource for collaborative translational science including a clinically annotated biobank. The submitted data represents the foundational analysis of 218 patients accrued at 7 academic medical centers. The analysis includes 176 patients with both targeted DNA sequencing and RNA sequencing. The genomic data was combined with clinical variables to model response to chemotherapy and immune checkpoint inhibitors (ICI). Due to additional sharing restrictions, data from one site can be found in phs003094.]]>
Inclusion Criteria: Subjects must meet all of the following applicable inclusion criteria to participate in this study: IRB-approved written informed consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately Age ≥ 18 years at the time of consentHistologically or cytologically confirmed urothelial cancer of the bladder, urethra, ureter, or renal pelvis Metastatic urothelial cancer as defined by M1 (distant metastatic disease) and/or N3 (nodes outside of the true pelvis) at the time of registrationTumor tissue available and suitable for molecular analyses from at least one of the following sources: Tissue previously stored at enrolling institution Tissue previously stored at an outside institution (other than enrolling institution) The tissue specimen may come in the form of a block or slides accessed under UC-GENOME from enrolled subjects. Needle biopsy is also acceptable. Details regarding collection requirements, processing and shipping can be found in the Correlative Laboratory Manual (CLM) Willing to provide access to tissue and blood for future research, including genetic studies Exclusion Criteria: Subjects meeting any of the criteria below may not participate in the study: Unwilling or unable to provide informed consent Affected by dementia, altered mental status, or any psychiatric or co-morbid condition that would prohibit the understanding or rendering of informed consent, as determined by treating physician]]>