UC-GENOME: Urothelial Cancer-GENOmic Analysis to iMprove Patient Outcomes and rEsearch
1 other identifier
interventional
219
1 country
8
Brief Summary
This comprehensive genomic analysis and biospecimen repository study incorporates Next Generation Sequencing (NGS) of archival tumor tissue from 200 subjects with metastatic urothelial cancer in support of several parallel goals. The immediate goal involves generation of a comprehensive report identifying subject specific genetic mutations and/or alterations based on NGS. Additionally, DNA and RNA extracted from tumor specimens and any remaining blocks/slides from the NGS will be stored for future research. Long-term, the goal of this endeavor is to support collaborative translational research projects in metastatic urothelial cancer by allowing investigators to interrogate abstracted coded clinical data linked to data from any biospecimen studies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2017
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 18, 2015
CompletedFirst Posted
Study publicly available on registry
December 30, 2015
CompletedStudy Start
First participant enrolled
July 26, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2023
CompletedSeptember 29, 2023
September 1, 2023
1.8 years
December 18, 2015
September 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of subjects who receive NGS and have a personalized report generated with potential treatment options
Subject-specific report that includes a summary of genomic alterations and potential therapeutic options based on the specific alterations and evidence discovered.
From date of consent to receipt of NGS report (estimate 14 days)
Collection of tissue and blood samples from subjects receiving treatment for urothelial cancer
Tissue and blood samples will be preserved and stored in a biorepository that cancer investigators can access for future IRB approved translational studies
From date of consent and retained indefinitely (estimate 10 years)
Secondary Outcomes (8)
Proportion of subjects whose personalized NGS report includes targeted therapy treatment options
From date of consent to receipt of NGS report by treating physician (estimate 14 days)
Proportion of subjects whose personalized NGS report includes potential clinical trial options
From date of consent to receipt of NGS report by treating physician (estimate 14 days)
Proportion of subjects who receive targeted therapy
From date of consent to receipt of NGS report by treating physician (estimate 14 days)
Collect comprehensive demographic data for all subjects enrolled in this clinical trial
From date of consent until end of therapy (assessed up to 2 years)
Collect comprehensive treatment histories for all subjects enrolled in this clinical trial
From date of consent until end of therapy (assessed up to 2 years)
- +3 more secondary outcomes
Study Arms (1)
UC Subjects
OTHERSubjects with confirmed metastatic urothelial cancer willing to participate in biospecimen collection (tissue and blood) for genetic studies.
Interventions
Subjects consent to provide access to archival tumor tissue and whole blood samples for genetic analysis. Subjects also consent to the indefinite use of their specimens and linked clinical information for ongoing or future research related to metastatic urothelial cancer.
Eligibility Criteria
You may qualify if:
- 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 consent.
- Histologically 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 registration.
- 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)
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Matthew Milowsky, MDlead
- Bladder Cancer Advocacy Networkcollaborator
- Hoosier Cancer Research Networkcollaborator
Study Sites (8)
University of Southern Cailfornia
Los Angeles, California, 90033, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, 21287, United States
Ichan School of Medicine at Mount Sinai
New York, New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
University of North Carolina - Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
University of Washignton/Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Matthew Milowsky, M.D.
Hoosier Cancer Research Network
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
December 18, 2015
First Posted
December 30, 2015
Study Start
July 26, 2017
Primary Completion
May 21, 2019
Study Completion
September 13, 2023
Last Updated
September 29, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share