AnemiaNCT00899665
Proteases in Patients With Prostate Cancer That Has Spread to the Bone
An observational study of Anemia and Metastatic Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, men only
- Conditions the study is for
- Anemia, Metastatic Cancer, Myelodysplastic Syndromes
- What is being tested?
- fluorescence in situ hybridization, microarray analysis and molecular diagnostic method
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to Jan 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48076
About this study
Official title: Proteases in Prostate Cancer Bone Metastasis
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.
Read the 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.
- Conditions
- Anemia, Metastatic Cancer, Myelodysplastic Syndromes, Precancerous Condition, Prostate Cancer
- Being tested
- fluorescence in situ hybridization, microarray analysis, molecular diagnostic method, immunohistochemistry staining method, laboratory biomarker analysis
- Keywords
- stage IV prostate cancer, bone metastases, anemia, monoclonal gammopathy of undetermined significance, de novo myelodysplastic syndromes, previously treated myelodysplastic syndromes, secondary myelodysplastic syndromes
- Medical subject headings
- Anemia, Neoplasm Metastasis, Myelodysplastic Syndromes, Precancerous Conditions, Prostatic Neoplasms, Monoclonal Gammopathy of Undetermined Significance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluorescence in situ hybridizationGenetic
microarray analysisGenetic
molecular diagnostic methodGenetic
laboratory biomarker analysisOther
biopsyProcedure or surgery
immunoscintigraphyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression and activity of proteases and related molecules
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startJul 2001
- Primary completionSep 2006
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barbara Ann Karmanos Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Michael L. Cher, MD, Study chair, Barbara Ann Karmanos Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899665
- Sponsor's protocol ID
- CDR0000483773
- Other IDs
- P30CA022453, WSU-D-2111, WSU-12-35-99(M02)
- Status last verified
- Feb 2014
- First submitted
- 9 May 2009
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proteases in Prostate Cancer Bone Metastasis
- ClinicalTrials.gov ID
- NCT00899665
- Acronym / sponsor ID
- CDR0000483773
- Conditions
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Barbara Ann Karmanos Cancer InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2001
- Primary completion
- Sep 2006 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 40 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fluorescence in situ hybridization | Genetic | – |
| microarray analysis | Genetic | – |
| molecular diagnostic method | Genetic | – |
| immunohistochemistry staining method | Other | – |
| laboratory biomarker analysis | Other | – |
| biopsy | Procedure or surgery | – |
| immunoscintigraphy | Procedure or surgery | – |
Primary outcome
Expression and activity of proteases and related molecules
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael L. Cher, MD study chair
Barbara Ann Karmanos Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Metastatic Cancer, run by Barbara Ann Karmanos Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression and activity of proteases and related molecules. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.