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Recruiting NCT01050504

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

— Observational Localized Renal Pelvis and Ureter Urothelial Carcinoma Malignant Solid Neoplasm Metastatic Malignant Neoplasm in the Bone Metastatic Malignant Neoplasm in the Soft Tissues

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cytology Specimen Collection Procedure, Laboratory Biomarker Analysis.
Who it may be relevant to
Registry conditions: Localized Renal Pelvis and Ureter Urothelial Carcinoma, Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Neoplasm in the Soft Tissues. Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Molecular Correlates of Sensitivity and Resistance to Therapy in Genitourinary Malignancy

Overview

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.

Interventions

  • Other Cytology Specimen Collection Procedure
    Correlative studies
  • Other Laboratory Biomarker Analysis
    Correlative studies

Primary outcome measures

  • 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]
Secondary outcome measures (2)
  • 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • Fred Hutch/University of Washington Cancer Consortium — Seattle

Identifiers

NCT: NCT01050504 · 6932 · NCI-2014-01087 · 6932p · 6932 · RG1712006 · P50CA097186

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗