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

NCT ID: NCT00899665

Last Updated: 2014-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2001-07-31

Study Completion Date

2008-01-31

Brief Summary

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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

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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.

Conditions

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Anemia Metastatic Cancer Myelodysplastic Syndromes Precancerous Condition Prostate Cancer

Interventions

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fluorescence in situ hybridization

Intervention Type GENETIC

microarray analysis

Intervention Type GENETIC

molecular diagnostic method

Intervention Type GENETIC

immunohistochemistry staining method

Intervention Type OTHER

laboratory biomarker analysis

Intervention Type OTHER

biopsy

Intervention Type PROCEDURE

immunoscintigraphy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Barbara Ann Karmanos Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael L. Cher, MD

Role: STUDY_CHAIR

Barbara Ann Karmanos Cancer Institute

Locations

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Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA022453

Identifier Type: NIH

Identifier Source: secondary_id

View Link

WSU-D-2111

Identifier Type: -

Identifier Source: secondary_id

WSU-12-35-99(M02)

Identifier Type: -

Identifier Source: secondary_id

CDR0000483773

Identifier Type: -

Identifier Source: org_study_id

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