Next Generation Sequencing in Improving Patient Outcomes and Research in Patients with Metastatic Urothelial Cancer

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Status: Closed to Accrual


This trial studies how well next generation sequencing works in improving patient outcomes and research in patients with urothelial cancer that has spread to other places in the body. Next generation sequencing involves the collection of blood and tissue samples in order to look at certain changes in genes from tumor samples to see if these changes are related to urothelial cancer and to see how well patients respond to treatment. This may help researchers refer patients to a clinical study, or help the treating doctor choose the next treatment for patients with urothelial cancer.

Eligibility Criteria

Inclusion Criteria

  • Institutional Review Board (IRB)-approved written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information; NOTE: HIPAA authorization may be included in the informed consent or obtained separately
  • Histologically or cytologically confirmed UC of the bladder, urethra, ureter, or renal pelvis
  • Metastatic UC as defined by M1 (distant metastatic disease) and/or N3 (nodes outside of the true pelvis) at the time of enrollment
  • Tumor 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)
  • Available tumor tissue must be from a formalin-fixed paraffin-embedded (FFPE) block with at least 60 um of tissue with >= 20% tumor content is needed for the analyses. Ideally, the tissue submitted will contain at least 75 um of tissue with >= 40% tumor content. The tissue specimen sent may come in the form of a block or slides or curls accessed under UC-GENOME from enrolled subjects. Details regarding collection, processing and shipping can be found in the Correlative Laboratory Manual (CLM) * NOTE: Prior to trial registration, the tumor content will be confirmed by central pathology review at Paradigm (a Next Generation Sequencing Company). If the tissue submitted does not meet the tumor cellularity requirements, additional tissue will be requested. If no further tissue is submitted or available, the subject will be ineligible to participate. Paradigm will contact Hoosier Cancer Research Network (HCRN) to relay this information
  • Willing to provide access to tissue and blood for future research including genetic studies

Exclusion Criteria

  • 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

Locations & Contacts

See trial information on for a list of participating sites.

Trial Objectives and Outline


I. To estimate the proportion of subjects with metastatic urothelial cancer (UC) enrolled who receive next generation sequencing (NGS) and have a personalized report generated with potential treatment options.

II. To create a biospecimen and data repository by collecting and storing blood and archival tumor tissue (biospecimens) from subjects and linking molecular and biological information from those biospecimens to clinical data in order to promote future translational research in metastatic UC.


I. To estimate the proportion of subjects whose personalized report from Paradigm includes targeted therapy options (approved or investigational drugs).

II. To estimate the proportion of subjects who enroll in a clinical trial of targeted therapy based on NGS results.

III. To estimate the proportion of subjects who receive targeted therapy (outside of a clinical trial) based on NGS results.

IV. To describe the demographics, treatment history and outcomes for subjects enrolled in the study.

V. To document the number and type of clinical trials and basic/translational science or other research projects based on the biospecimen and data repository.


Patients undergo biospecimen collection and provide blood and archival tissue samples for next generation sequencing.

After completion of study, patients are followed up every 6 months.

Trial Phase & Type

Trial Phase

No phase specified

Trial Type


Lead Organization

Lead Organization
UNC Lineberger Comprehensive Cancer Center

Principal Investigator
Matthew Ivan Milowsky

Trial IDs

Primary ID GU15-217
Secondary IDs NCI-2018-02170 ID NCT02643043