UC-GENOME: Urothelial Cancer-GENOmic Analysis to iMprove Patient Outcomes and rEsearch
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02643043|
Recruitment Status : Active, not recruiting
First Posted : December 30, 2015
Last Update Posted : April 11, 2023
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Urothelial Carcinoma Bladder Cancer Urethral Cancer Cancer of the Ureter||Other: Biospecimen Collection||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||UC-GENOME: Urothelial Cancer-GENOmic Analysis to iMprove Patient Outcomes and rEsearch: Hoosier Cancer Research Network GU15-217|
|Actual Study Start Date :||July 26, 2017|
|Estimated Primary Completion Date :||August 2023|
|Estimated Study Completion Date :||January 2024|
Subjects with confirmed metastatic urothelial cancer willing to participate in biospecimen collection (tissue and blood) for genetic studies.
Other: Biospecimen Collection
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.
- Proportion of subjects who receive NGS and have a personalized report generated with potential treatment options [ Time Frame: From date of consent to receipt of NGS report (estimate 14 days) ]Subject-specific report that includes a summary of genomic alterations and potential therapeutic options based on the specific alterations and evidence discovered.
- Collection of tissue and blood samples from subjects receiving treatment for urothelial cancer [ Time Frame: From date of consent and retained indefinitely (estimate 10 years) ]Tissue and blood samples will be preserved and stored in a biorepository that cancer investigators can access for future IRB approved translational studies
- Proportion of subjects whose personalized NGS report includes targeted therapy treatment options [ Time Frame: From date of consent to receipt of NGS report by treating physician (estimate 14 days) ]Subjects whose treatment options include targeted therapy, of either approved or investigational drugs
- Proportion of subjects whose personalized NGS report includes potential clinical trial options [ Time Frame: From date of consent to receipt of NGS report by treating physician (estimate 14 days) ]Subjects who enroll in a clinical trial based on NGS results.
- Proportion of subjects who receive targeted therapy [ Time Frame: From date of consent to receipt of NGS report by treating physician (estimate 14 days) ]Subjects who receive targeted therapy, outside of a clinical trial, based on NGS results
- Collect comprehensive demographic data for all subjects enrolled in this clinical trial [ Time Frame: From date of consent until end of therapy (assessed up to 2 years) ]Subject demographic characteristics compiled and recorded in a data repository, maintained in a secure platform, that will provide an archive for future research.
- Collect comprehensive treatment histories for all subjects enrolled in this clinical trial [ Time Frame: From date of consent until end of therapy (assessed up to 2 years) ]Subject treatment histories compiled and recorded in a data repository, maintained in a secure platform, that will provide an archive for future research.
- Collect comprehensive clinical outcomes for all subjects enrolled in this clinical trial [ Time Frame: From date of consent until end of therapy (assessed up to 2 years) ]Subject clinical outcomes data compiled and recorded in a data repository, maintained in a secure platform, that will provide an archive for future research.
- Research projects resulting from biospecimen and data repository [ Time Frame: From study close until all biospecimens and data have been utilized (estimate 10 years) ]Number and type of clinical trials and basic/translational science or other research projects initiated, based on the biospecimen and data repository
- Overall Survival (OS) [ Time Frame: From treatment initiation until death as a result of any cause, up to 60 months ]Compare the overall survival for patients with metastatic urothelial cancer who received a treatment based on the NGS results (on or off of a clinical trial) to those patients who did not
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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 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.
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02643043
|United States, California|
|University of Southern Cailfornia|
|Los Angeles, California, United States, 90033|
|United States, Illinois|
|University of Chicago Medical Center|
|Chicago, Illinois, United States, 60637|
|United States, Maryland|
|Johns Hopkins Sidney Kimmel Comprehensive Cancer Center|
|Baltimore, Maryland, United States, 21287|
|United States, New York|
|Ichan School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, North Carolina|
|University of North Carolina - Lineberger Comprehensive Cancer Center|
|Chapel Hill, North Carolina, United States, 27599|
|United States, Pennsylvania|
|Fox Chase Cancer Center|
|Philadelphia, Pennsylvania, United States, 19111|
|United States, Washington|
|University of Washignton/Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Study Chair:||Matthew Milowsky, M.D.||Hoosier Cancer Research Network|
|Responsible Party:||Matthew Milowsky, MD, Sponsor-Investigator, Hoosier Cancer Research Network|
|Other Study ID Numbers:||
|First Posted:||December 30, 2015 Key Record Dates|
|Last Update Posted:||April 11, 2023|
|Last Verified:||April 2023|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Next Generation Sequencing
Neoplasms by Site
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases