Are you healthy and looking to help advance medical science?

You may be eligible to participate in a metastatic malignant neoplasm in the bone clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a metastatic malignant neoplasm in the bone clinical study, and could be compensated for your time.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Metastatic Malignant Neoplasm in the Bone Clinical Trial in Seattle WA

NCT01050504 | Observational

Are you healthy and looking to help advance medical science?

You may be eligible to participate in a metastatic malignant neoplasm in the bone clinical study, and could be compensated for your time.

Are you healthy and looking to help advance medical science? You may be eligible to participate in a metastatic malignant neoplasm in the bone clinical study, and could be compensated for your time.

Recruiting

Male

18 Years +

This study is looking to recruit 1500 Participants

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.

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Details for the study

Population

Patients with prostate or bladder/urothelial cancer treated in genitourinary oncology practices at University of Washington Medical Center, Seattle Cancer care Alliance and Harborview Medical Center and healthy controls

Brief Title

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

Official Title

Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy

Brief 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.

Detailed Description

OUTLINE:

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

Treatments and/or Procedures

Cytology specimen collection procedure

Correlative studies

Laboratory biomarker analysis

Correlative studies

Study 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