NCT00899665

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2001

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2009

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

5.2 years

First QC Date

May 9, 2009

Last Update Submit

February 10, 2014

Conditions

AnemiaMetastatic CancerMyelodysplastic SyndromesPrecancerous ConditionProstate Cancer

Keywords

stage IV prostate cancerbone metastasesanemiamonoclonal gammopathy of undetermined significancede novo myelodysplastic syndromespreviously treated myelodysplastic syndromessecondary myelodysplastic syndromes

Outcome Measures

Primary Outcomes (1)

  • Expression and activity of proteases and related molecules

Interventions

fluorescence in situ hybridizationGENETIC
microarray analysisGENETIC
molecular diagnostic methodGENETIC
immunohistochemistry staining methodOTHER
laboratory biomarker analysisOTHER
biopsyPROCEDURE
immunoscintigraphyPROCEDURE

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48076, United States

Location

MeSH Terms

Conditions

AnemiaNeoplasm MetastasisMyelodysplastic SyndromesPrecancerous ConditionsProstatic NeoplasmsMonoclonal Gammopathy of Undetermined Significance

Interventions

In Situ Hybridization, FluorescenceMicroarray AnalysisMolecular Diagnostic TechniquesImmunohistochemistryBiopsyRadioimmunodetection

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and SymptomsBone Marrow DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesHypergammaglobulinemiaBlood Protein DisordersParaproteinemiasImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

In Situ HybridizationStaining and LabelingHistocytological Preparation TechniquesCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHistological TechniquesInvestigative TechniquesCytogenetic AnalysisGenetic TechniquesNucleic Acid HybridizationMicrochip Analytical ProceduresHistocytochemistryImmunologic TechniquesCytodiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeRadionuclide ImagingDiagnostic ImagingDiagnostic Techniques, Radioisotope

Study Officials

  • Michael L. Cher, MD

    Barbara Ann Karmanos Cancer Institute

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2009

First Posted

May 12, 2009

Study Start

July 1, 2001

Primary Completion

September 1, 2006

Study Completion

January 1, 2008

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations

US(1)