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Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer
NCT01050504 · University of Washington
In plain English
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Official title
Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy
About this study
OUTLINE:
Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.
Eligibility criteria
Inclusion Criteria:
* Patients with localized and/or metastatic bladder/urothelial or prostate cancer who have disease in the primary organ, biopsy accessible bone metastases (collaborating radiologists will determine if bone metastasis is appropriate for biopsy) or soft tissue metastases are eligible; men and women without cancer are eligible to have blood or normal tissue collected if acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder); in patients without malignancy, no additional tissue beyond that necessary for care will be procured
* Ability to adequately understand and give informed consent
* Local or metastatic disease to soft tissue or bone at sites accessible to biopsy with minimal risk of complications Or the ability to obtain tissue with minimal risk of complication from a surgical procedure being conducted as a part of another research study Or for standard of care purposes or patients who have archival tissue collected for research or standard of care who are willing to donate archival tissue for this study
* Alternatively, men and women without cancer or who are at risk of developing cancer are eligible to have blood or normal tissue collected if acquired; tissue will only be acquired as part of non-research procedures (e.g. transurethral resection of the prostate or bladder; in patients without malignancy, no additional tissue beyond that necessary for care will be procured
* Platelet count \> 50,000
* White blood cell (WBC) \> 1,500
* Hemoglobin (Hgb) \> 8.0
* International normalized ratio (INR) \< 1.5
* Partial thromboplastin time (PTT) \< 45
* No history of excessive unexplained bleeding from previous surgery
Exclusion Criteria:
* Patients unable to stop chronic anticoagulation with warfarin or Lovenox for less than 3 days
* Serious or uncontrolled infection
* Treatment with a vascular endothelial growth factor (VEGF) inhibitor (such as Avastin) within the past 28 days
Study design
Enrollment target: 1500 participants
Age groups: adult, older_adult
Timeline
Starts: 2009-08
Estimated completion: 2029-01-31
Last updated: 2026-01-15
Interventions
Other: Cytology Specimen Collection ProcedureOther: Laboratory Biomarker Analysis
Primary outcomes
- • DNA genomic sequencing (Up to 6 years)
- • Gene expression profile using microarray assays (Up to 6 years)
- • Mutation mapping using the OncoMap and other genotyping techniques (Up to 6 years)
Sponsor
University of Washington · other
With: National Cancer Institute (NCI)
Contacts & investigators
ContactRobert B. Montgomery · contact · rbmontgo@uw.edu · 206-598-0856
InvestigatorRobert B. Montgomery · principal_investigator, Fred Hutch/University of Washington Cancer Consortium
All locations (1)
Fred Hutch/University of Washington Cancer ConsortiumRecruiting
Seattle, Washington, United States