Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer

STATUS

Recruiting
End date

Sep 1, 2024
participants needed

1500
sponsor

University of Washington

Send

Updated on 11 July 2022

See if I qualify

platelet count

cancer

metastasis

bone metastases

transurethral resection

Accepts healthy volunteers

Summary

This study collects and studies tissue and blood samples from patients with prostate or bladder/urothelial cancer that has recurred (come back) at or near the same place as the original (primary) tumor or has spread to other parts of the body. Studying samples of blood and tissue samples from patients with prostate or bladder/urothelial cancer in the laboratory may help doctors learn more about new biomarkers, potential drug targets, and resistance developing in response to treatment. It may also help doctors find better ways to treat the cancer.

Description

OUTLINE

Patients undergo collection of blood and tissue samples for analysis via mutation mapping, DNA sequencing, gene expression microarray, and gene profiling.

Details

Condition	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
Treatment	laboratory biomarker analysis, cytology specimen collection procedure
Clinical Study Identifier	NCT01050504
Sponsor	University of Washington
Last Modified on	11 July 2022

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Eligibility		Yes	No	Not Sure
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

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Collecting and Studying Blood and Tissue Samples From Patients With Locally Recurrent or Metastatic Prostate or Bladder/Urothelial Cancer