Prostate CancerNCT00900185
Study of a Polymorphism in Patients With Prostate Cancer
An observational study of Prostate Cancer, run by National Cancer Institute (NCI).
Trial summary
RATIONALE: Studying samples of blood from patients with cancer and from healthy participants in the laboratory may help doctors learn more about changes that may occur in DNA. PURPOSE: This laboratory study is looking at blood samples from patients with prostate cancer and from healthy participants to identify a… Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- mutation analysis, polymerase chain reaction and polymorphism analysis
- How many people
- 750 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- 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 Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of prostate cancer OR healthy participant
- Patient enrolled on an IRB-approved clinical trial at the National Cancer Institute or Northwestern University, including, but not limited to, any of the following:
- NCI-99-C-0052
- NCI-95-C-0178
- NCI-00-C-003
- NCI-00-C-0080
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
Official title: Retrospective Analysis of Endostatin Genotype in Prostate Cancer Patients to Assess the Association of a Single Nucleotide Polymorphism (D104N) in Endostatin and Prostate Cancer
RATIONALE: Studying samples of blood from patients with cancer and from healthy participants in the laboratory may help doctors learn more about changes that may occur in DNA.
PURPOSE: This laboratory study is looking at blood samples from patients with prostate cancer and from healthy participants to identify a polymorphism that may help in the study of prostate cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the incidence of the D104N COL18A1 polymorphism in patients with prostate cancer.
Secondary
- Determine the incidence of this polymorphism in African-American patients with prostate cancer.
OUTLINE: This is a retrospective, multicenter study.
DNA is extracted from preexisting serum samples and polymerase chain reaction is performed to determine the genotype pattern.
PROJECTED ACCRUAL: A total of 500 patients and 250 healthy participants will be accrued for this study.
- Conditions
- Prostate Cancer
- Being tested
- mutation analysis, polymerase chain reaction, polymorphism analysis
- Keywords
- recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mutation analysisGenetic
polymerase chain reactionGenetic
polymorphism analysisGenetic
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of D104N COL18A1 polymorphism in patients with prostate cancer and in healthy participants
Secondary outcomes (1)
Frequency of D104N COL18A1 polymorphism in African-American patients with prostate cancer and in healthy participants
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)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- 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
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Investigators
- William D. Figg, PharmD, Study chair, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900185
- Sponsor's protocol ID
- CDR0000304552
- Other IDs
- NCI-03-C-0153, NU-98U2
- Status last verified
- Feb 2007
- First submitted
- 9 May 2009
- Last updated
- 30 Apr 2015
- Results posted
- No
Publications
Macpherson GR, Singh AS, Bennett CL, Venzon DJ, Liewehr DJ, Franks ME, Dahut WL, Kantoff PW, Price DK, Figg WD. Genotyping and functional analysis of the D104N variant of human endostatin. Cancer Biol Ther. 2004 Dec;3(12):1298-303. doi: 10.4161/cbt.3.12.1453. Epub 2004 Dec 16.
PubMed 15662127Price DK, Macpherson GR, Dahut W, et al.: A mutation in COL18A1 and the association with prostate cancer. [Abstract] American Association for Cancer Research: 94th Annual Meeting, 11-14th July 2003, Washington, D.C. 44: A-4054, 810, 2003.
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Analysis of Endostatin Genotype in Prostate Cancer Patients to Assess the Association of a Single Nucleotide Polymorphism (D104N) in Endostatin and Prostate Cancer
- ClinicalTrials.gov ID
- NCT00900185
- Acronym / sponsor ID
- CDR0000304552
- Conditions
- Prostate Cancer
- Keywords
- recurrent prostate cancer, stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- 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: Studying samples of blood from patients with cancer and from healthy participants in the laboratory may help doctors learn more about changes that may occur in DNA.
PURPOSE: This laboratory study is looking at blood samples from patients with prostate cancer and from healthy participants to identify a polymorphism that may help in the study of prostate cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the incidence of the D104N COL18A1 polymorphism in patients with prostate cancer.
Secondary
- Determine the incidence of this polymorphism in African-American patients with prostate cancer.
OUTLINE: This is a retrospective, multicenter study.
DNA is extracted from preexisting serum samples and polymerase chain reaction is performed to determine the genotype pattern.
PROJECTED ACCRUAL: A total of 500 patients and 250 healthy participants will be accrued for this study.
Study design
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, 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 |
|---|---|---|
| mutation analysis | Genetic | – |
| polymerase chain reaction | Genetic | – |
| polymorphism analysis | Genetic | – |
Primary outcome
Frequency of D104N COL18A1 polymorphism in patients with prostate cancer and in healthy participants
1 secondary outcome
Frequency of D104N COL18A1 polymorphism in African-American patients with prostate cancer and in healthy participants
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 30 Apr 2015.
- Results publication: PubMed 15662127Macpherson GR, Singh AS, Bennett CL, Venzon DJ, Liewehr DJ, Franks ME, Dahut WL, Kantoff PW, Price DK, Figg WD. Genotyping and functional analysis of the D104N variant of human endostatin. Cancer Biol Ther. 2004 Dec;3(12):1298-303. doi: 10.4161/cbt.3.12.1453. Epub 2004 Dec 16.
- Results publicationPrice DK, Macpherson GR, Dahut W, et al.: A mutation in COL18A1 and the association with prostate cancer. [Abstract] American Association for Cancer Research: 94th Annual Meeting, 11-14th July 2003, Washington, D.C. 44: A-4054, 810, 2003.
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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.
William D. Figg, PharmD study chair
National Cancer Institute (NCI)
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by National Cancer Institute (NCI).
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Frequency of D104N COL18A1 polymorphism in patients with prostate cancer and in healthy participants. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00900185, which also lists 2 linked publications.
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 30 Apr 2015.