Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer
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ClinicalTrials.gov Identifier: NCT01050504 |
Recruitment Status :
Recruiting
First Posted : January 15, 2010
Last Update Posted : January 25, 2024
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Condition or disease | Intervention/treatment |
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Localized Renal Pelvis and Ureter Urothelial Carcinoma Malignant Solid Neoplasm Metastatic Malignant Neoplasm in the Bone Metastatic Malignant Neoplasm in the Soft Tissues Metastatic Renal Pelvis and Ureter Urothelial Carcinoma Recurrent Bladder Carcinoma Recurrent Prostate Carcinoma Recurrent Renal Pelvis and Ureter Urothelial Carcinoma Stage IV Bladder Cancer AJCC v7 Stage IV Bladder Urothelial Carcinoma AJCC v7 Stage IV Prostate Cancer AJCC v7 | Other: Cytology Specimen Collection Procedure Other: Laboratory Biomarker Analysis |
Study Type : | Observational |
Estimated Enrollment : | 1500 participants |
Observational Model: | Case-Control |
Time Perspective: | Prospective |
Official Title: | Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy |
Study Start Date : | August 2009 |
Estimated Primary Completion Date : | January 31, 2029 |
Estimated Study Completion Date : | January 31, 2029 |
Group/Cohort | Intervention/treatment |
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Ancillary-correlative (blood and tissue collection)
Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.
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Other: Cytology Specimen Collection Procedure
Correlative studies
Other Name: Cytologic Sampling Other: Laboratory Biomarker Analysis Correlative studies |
- DNA genomic sequencing [ Time Frame: Up to 6 years ]
- Gene expression profile using microarray assays [ Time Frame: Up to 6 years ]
- Mutation mapping using the OncoMap and other genotyping techniques [ Time Frame: Up to 6 years ]
- Expression of androgen metabolic enzymes by quantitative real time-polymerase chain reaction [ Time Frame: Up to 6 years ]
- Proteomic profile [ Time Frame: Up to 6 years ]
Biospecimen Retention: Samples With DNA
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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
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): NCT01050504
Contact: Robert B. Montgomery | 206-598-0856 | rbmontgo@uw.edu |
United States, Washington | |
Fred Hutch/University of Washington Cancer Consortium | Recruiting |
Seattle, Washington, United States, 98109 | |
Contact: Robert B. Montgomery 206-598-0856 rbmontgo@uw.edu | |
Principal Investigator: Robert B. Montgomery |
Principal Investigator: | Robert B. Montgomery | Fred Hutch/University of Washington Cancer Consortium |
Responsible Party: | University of Washington |
ClinicalTrials.gov Identifier: | NCT01050504 |
Other Study ID Numbers: |
6932 NCI-2014-01087 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 6932p 6932 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) RG1712006 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium ) P50CA097186 ( U.S. NIH Grant/Contract ) |
First Posted: | January 15, 2010 Key Record Dates |
Last Update Posted: | January 25, 2024 |
Last Verified: | January 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Carcinoma Neoplasms Urinary Bladder Neoplasms Carcinoma, Transitional Cell Neoplasms, Second Primary Kidney Neoplasms Ureteral Neoplasms Recurrence Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Disease Attributes Pathologic Processes |
Urogenital Neoplasms Neoplasms by Site Urogenital Diseases Male Urogenital Diseases Urologic Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Urinary Bladder Diseases Urologic Diseases Kidney Diseases Ureteral Diseases |