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UC-GENOME: Urothelial Cancer-GENOmic Analysis to iMprove Patient Outcomes and rEsearch

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ClinicalTrials.gov Identifier: NCT02643043
Recruitment Status : Recruiting
First Posted : December 30, 2015
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
Bladder Cancer Advocacy Network (BCAN®)
Hoosier Cancer Research Network
Information provided by (Responsible Party):
Matthew Milowsky, MD, Hoosier Cancer Research Network

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.

Condition or disease Intervention/treatment
Urothelial Carcinoma Bladder Cancer Urethral Cancer Cancer of the Ureter Other: Biospecimen Collection

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
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 : March 2019
Estimated Study Completion Date : December 2019


Group/Cohort Intervention/treatment
UC Subjects
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.




Primary Outcome Measures :
  1. 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.

  2. 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


Secondary Outcome Measures :
  1. 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

  2. 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.

  3. 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

  4. 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.

  5. 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.

  6. 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.

  7. 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


Biospecimen Retention:   Samples With DNA
Collect and store whole 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 urothelial cancer. Any DNA analysis of blood is for research purposes only.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with histologically or cytologically confirmed metastatic urothelial cancer of the bladder, urethra, ureter, or renal pelvis at the time of enrollment, who have agreed to provide access to tumor tissue and blood collection for genetic studies.
Criteria

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 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.

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.

Information from the National Library of Medicine

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


Contacts
Contact: Matthew Milowsky, M.D. 866.869.1856 matt_milowsky@med.unc.edu
Contact: Michael Nunley 317.634.5842 ext 17 mnunley@hoosiercancer.org

Locations
United States, California
University of Southern Cailfornia Recruiting
Los Angeles, California, United States, 90033
Contact: Charis Barg       cbarg@usc.edu   
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Peter O'Donnell, MD         
United States, Maryland
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center Recruiting
Baltimore, Maryland, United States, 21287
Contact: Rehab Abdallah    410-955-4042    rabdall1@jhmi.edu   
Principal Investigator: Noah Hahn, MD         
United States, New York
Ichan School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Alexa Leib    212-824-7319    alexa.leib@mssm.edu   
Principal Investigator: Matthew Galsky, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Min -Yuen Teo    914-367-7393    teom@mskcc.org   
Principal Investigator: Gopakumar Iyer, MD         
United States, North Carolina
University of North Carolina - Lineberger Comprehensive Cancer Center Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Matthew Milowsky, M.D.         
United States, Pennsylvania
Fox Chase Cancer Center Recruiting
Philadelphia, Pennsylvania, United States, 19111
Contact: Elizabeth Pilmack, MD         
United States, Washington
University of Washignton/Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Anne Lee    206-606-1796    alee2@seattlecca.org   
Principal Investigator: Evan Yu, MD         
Sponsors and Collaborators
Matthew Milowsky, MD
Bladder Cancer Advocacy Network (BCAN®)
Hoosier Cancer Research Network
Investigators
Study Chair: Matthew Milowsky, M.D. Hoosier Cancer Research Network

Additional Information:
Responsible Party: Matthew Milowsky, MD, Sponsor-Investigator, Hoosier Cancer Research Network
ClinicalTrials.gov Identifier: NCT02643043     History of Changes
Other Study ID Numbers: HCRN GU15-217
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Matthew Milowsky, MD, Hoosier Cancer Research Network:
Next Generation Sequencing
Genomic Analysis

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urethral Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urethral Diseases
Ureteral Diseases