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Proteases in Patients With Prostate Cancer That Has Spread to the Bone

Primary Purpose

Anemia, Metastatic Cancer, Myelodysplastic Syndromes

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
fluorescence in situ hybridization
microarray analysis
molecular diagnostic method
immunohistochemistry staining method
laboratory biomarker analysis
biopsy
immunoscintigraphy
Sponsored by
Barbara Ann Karmanos Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Anemia focused on measuring stage IV prostate cancer, bone metastases, anemia, monoclonal gammopathy of undetermined significance, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Meets 1 of the following criteria:

    • Diagnosis of metastatic prostate cancer

      • Patients with documented bone metastases on radiologic imaging studies must undergo bone marrow biopsy

    • Male patients ≥ 50 years of age without cancer who are scheduled to undergo bone biopsy for other clinically indicated reasons, including any of the following:

      • Myelodysplasia
      • Anemia
      • Monoclonal gammopathy of undetermined significance
    • Male or female patients ≥ 40 years of age without metastatic bone cancer who are scheduled to undergo an orthopedic procedure involving removal of bone specimen

PATIENT CHARACTERISTICS:

  • See Disease Characteristics

PRIOR CONCURRENT THERAPY:

  • Not specified

Sites / Locations

  • Barbara Ann Karmanos Cancer Institute

Outcomes

Primary Outcome Measures

Expression and activity of proteases and related molecules

Secondary Outcome Measures

Full Information

First Posted
May 9, 2009
Last Updated
February 10, 2014
Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00899665
Brief Title
Proteases in Patients With Prostate Cancer That Has Spread to the Bone
Official Title
Proteases in Prostate Cancer Bone Metastasis
Study Type
Observational

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
September 2006 (Actual)
Study Completion Date
January 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barbara Ann Karmanos Cancer Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Collecting and storing samples of bone marrow and tissue from patients to test in the laboratory may help the study of cancer. PURPOSE: This laboratory study is comparing proteases (enzymes that break down protein) in patients with prostate cancer that has spread to the bone with patients who do not have cancer that has spread to the bone.
Detailed Description
OBJECTIVES: Examine the roles of proteases and protease-associated molecules in bone metastases in patients with metastatic prostate cancer. OUTLINE: Patients undergo bone marrow aspiration and core bone biopsies. Tissues are analyzed by immunohistochemistry methods, in situ hybridization assays, gelatin zymography and/or Western blot analysis, and gene profiling analysis in order to visualize and quantitate protease or protease-related levels. PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Metastatic Cancer, Myelodysplastic Syndromes, Precancerous Condition, Prostate Cancer
Keywords
stage IV prostate cancer, bone metastases, anemia, monoclonal gammopathy of undetermined significance, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes

7. Study Design

Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Genetic
Intervention Name(s)
fluorescence in situ hybridization
Intervention Type
Genetic
Intervention Name(s)
microarray analysis
Intervention Type
Genetic
Intervention Name(s)
molecular diagnostic method
Intervention Type
Other
Intervention Name(s)
immunohistochemistry staining method
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Type
Procedure
Intervention Name(s)
biopsy
Intervention Type
Procedure
Intervention Name(s)
immunoscintigraphy
Primary Outcome Measure Information:
Title
Expression and activity of proteases and related molecules

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Meets 1 of the following criteria: Diagnosis of metastatic prostate cancer Patients with documented bone metastases on radiologic imaging studies must undergo bone marrow biopsy Male patients ≥ 50 years of age without cancer who are scheduled to undergo bone biopsy for other clinically indicated reasons, including any of the following: Myelodysplasia Anemia Monoclonal gammopathy of undetermined significance Male or female patients ≥ 40 years of age without metastatic bone cancer who are scheduled to undergo an orthopedic procedure involving removal of bone specimen PATIENT CHARACTERISTICS: See Disease Characteristics PRIOR CONCURRENT THERAPY: Not specified
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael L. Cher, MD
Organizational Affiliation
Barbara Ann Karmanos Cancer Institute
Official's Role
Study Chair
Facility Information:
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States

12. IPD Sharing Statement

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Proteases in Patients With Prostate Cancer That Has Spread to the Bone

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