Prostate CancerNCT00022919
Analysis of Prostate Cancer Short-Term Cultures Using Molecular Cytogenetic Methods
An observational study of Prostate Cancer, run by National Human Genome Research Institute (NHGRI) at 1 site in United States.
Trial summary
This study will examine prostate tumor tissue cultures to try to identify genetic abnormalities that contribute to the cause or progression of the disease. Patients with prostate cancer enrolled in the National Cancer Institute protocol 97-C-0147 (Collection of Serum and Tissue Samples from Patients with Biopsy-Proved… Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to Aug 2004
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Only patients who have met pathologic criteria for prostate intraepithelial neoplasia or higher (determined by pathologists included in the NCI protocol) will be included for entry into this protocol.
Who cannot join
- No prisoners, decisionally impaired, healthy volunteers, or lab personnel will be included in this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Human Genome Research Institute (NHGRI)
Bethesda, Maryland, 20892
About this study
Official title: Analysis of Prostate Cancer Short-Term Cultures Utilizing Molecular Cytogenetic Methods
This study will examine prostate tumor tissue cultures to try to identify genetic abnormalities that contribute to the cause or progression of the disease.
Patients with prostate cancer enrolled in the National Cancer Institute protocol 97-C-0147 (Collection of Serum and Tissue Samples from Patients with Biopsy-Proved or Suspected Malignant Disease) may be eligible for this study.
Specimens for tissue culture for this study will be obtained from tumors surgically removed from patients participating in NCI protocol 97-C-0146.
The findings of this study may lead to better methods of predicting the course of disease in individual patients.
Read the detailed description
Prostate cancer is the most common solid tumor in American males and the most common malignancy among men in Western industrialized countries. Widespread testing for early detection of prostate cancer utilizing digital rectal examination and prostate specific antigen (PSA) has led to a significant clinical conundrum. Differentiating organ confined indolent disease from aggressive cancer has been imperfect. Nonetheless, increased detection has led to increased radical prostatectomies. A prevailing goal of the contemporary, ardent research seeks to discover a molecular biomarker for prognostication.
Given the limitations of the current knowledge of the molecular pathology of prostate cancer, there are several viewpoints regarding the process of tumorigenesis. However, a generally accepted hypothetical model describes normal prostatic epithelium progressing to a pre-malignant or low-grade prostatic intraepithelial neoplasia (PIN). Then, after further genetic alterations, a succession of histologically apparent adenocarcinoma--first confined, then metastatic, and finally refractory to hormone treatment ensues. Current molecular research has shown already complex genetics alterations at the high-grade prostatic intraepithelial neoplasia stage. Thus, invasive disease represents amplification or further aberration of precursor events. The seminal event or events have not been recognized and the undiscovered tumor suppressor gene or proto-oncogene may be a principal tumor marker.
The purpose of this study is to identify specific, shared, consistent, chromosomal rearrangements found in metaphase preparations for short-term cultures of pathologically identified and scored primary prostate tumors. These, tumor specimens will be obtained from patients enrolled in protocol (97-C-0147) by the NCI. Fresh tumor, taken from bi-valved specimens with one half undergoing tissue pathology, will be immediately placed in growth media and transferred as a coded specimen as a sample from patients selected and enrolled in protocol (97-C-0147). Informed consent will be obtained by participating investigators in the NCI protocol. The outcome measurement will be the characterization, or failure of characterization, of specific, shared consistent, chromosomal rearrangements. Current molecular cytogenetics technologies, primarily utilizing chromosomal microdissection, will be employed toward this goal. Ultimately, this research may help to focus further molecular studies towards the ultimate goal of finding a unique, cancer specific alteration.
- Conditions
- Prostate Cancer
- Keywords
- Microdissection, Chromosome, Karyotype, Tumor, Malignancy, Prostate Adenocarcinoma, Prostate Intraepithelial Neoplasia, Prostate Cancer, Prostate
- Medical subject headings
- Prostatic Neoplasms, Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2001 (estimated)
- Study startAug 2001
- Study completionAug 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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
- 150 participants
Sponsor and investigators
- Lead sponsor
- National Human Genome Research Institute (NHGRI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00022919
- Sponsor's protocol ID
- 010212
- Other IDs
- 01-HG-0212
- Status last verified
- Aug 2004
- First submitted
- 16 Aug 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Reiter RE, Gu Z, Watabe T, Thomas G, Szigeti K, Davis E, Wahl M, Nisitani S, Yamashiro J, Le Beau MM, Loda M, Witte ON. Prostate stem cell antigen: a cell surface marker overexpressed in prostate cancer. Proc Natl Acad Sci U S A. 1998 Feb 17;95(4):1735-40. doi: 10.1073/pnas.95.4.1735.
PubMed 9465086Nupponen NN, Isola J, Visakorpi T. Mapping the amplification of EIF3S3 in breast and prostate cancer. Genes Chromosomes Cancer. 2000 Jun;28(2):203-10.
PubMed 10825005Nupponen NN, Visakorpi T. Molecular cytogenetics of prostate cancer. Microsc Res Tech. 2000 Dec 1;51(5):456-63. doi: 10.1002/1097-0029(20001201)51:53.0.CO;2-H.
PubMed 11074616
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Prostate Cancer Short-Term Cultures Utilizing Molecular Cytogenetic Methods
- ClinicalTrials.gov ID
- NCT00022919
- Acronym / sponsor ID
- 010212
- Conditions
- Prostate Cancer
- Keywords
- Microdissection, Chromosome, Karyotype, Tumor, Malignancy, Prostate Adenocarcinoma, Prostate Intraepithelial Neoplasia, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- National Human Genome Research Institute (NHGRI)US National Institutes of Health
- Study start
- Aug 2001
- Study completion
- Aug 2004
- First posted
- 17 Aug 2001 (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.
This study will examine prostate tumor tissue cultures to try to identify genetic abnormalities that contribute to the cause or progression of the disease.
Patients with prostate cancer enrolled in the National Cancer Institute protocol 97-C-0147 (Collection of Serum and Tissue Samples from Patients with Biopsy-Proved or Suspected Malignant Disease) may be eligible for this study.
Specimens for tissue culture for this study will be obtained from tumors surgically removed from patients participating in NCI protocol 97-C-0146.
The findings of this study may lead to better methods of predicting the course of disease in individual patients.
Detailed description
Prostate cancer is the most common solid tumor in American males and the most common malignancy among men in Western industrialized countries. Widespread testing for early detection of prostate cancer utilizing digital rectal examination and prostate specific antigen (PSA) has led to a significant clinical conundrum. Differentiating organ confined indolent disease from aggressive cancer has been imperfect. Nonetheless, increased detection has led to increased radical prostatectomies. A prevailing goal of the contemporary, ardent research seeks to discover a molecular biomarker for prognostication.
Given the limitations of the current knowledge of the molecular pathology of prostate cancer, there are several viewpoints regarding the process of tumorigenesis. However, a generally accepted hypothetical model describes normal prostatic epithelium progressing to a pre-malignant or low-grade prostatic intraepithelial neoplasia (PIN). Then, after further genetic alterations, a succession of histologically apparent adenocarcinoma--first confined, then metastatic, and finally refractory to hormone treatment ensues. Current molecular research has shown already complex genetics alterations at the high-grade prostatic intraepithelial neoplasia stage. Thus, invasive disease represents amplification or further aberration of precursor events. The seminal event or events have not been recognized and the undiscovered tumor suppressor gene or proto-oncogene may be a principal tumor marker.
The purpose of this study is to identify specific, shared, consistent, chromosomal rearrangements found in metaphase preparations for short-term cultures of pathologically identified and scored primary prostate tumors. These, tumor specimens will be obtained from patients enrolled in protocol (97-C-0147) by the NCI. Fresh tumor, taken from bi-valved specimens with one half undergoing tissue pathology, will be immediately placed in growth media and transferred as a coded specimen as a sample from patients selected and enrolled in protocol (97-C-0147). Informed consent will be obtained by participating investigators in the NCI protocol. The outcome measurement will be the characterization, or failure of characterization, of specific, shared consistent, chromosomal rearrangements. Current molecular cytogenetics technologies, primarily utilizing chromosomal microdissection, will be employed toward this goal. Ultimately, this research may help to focus further molecular studies towards the ultimate goal of finding a unique, cancer specific alteration.
Study design
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Only patients who have met pathologic criteria for prostate intraepithelial neoplasia or higher (determined by pathologists included in the NCI protocol) will be included for entry into this protocol.
Key exclusion criteria (1 listed)
- No prisoners, decisionally impaired, healthy volunteers, or lab personnel will be included in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Mar 2008.
- Background: PubMed 9465086Reiter RE, Gu Z, Watabe T, Thomas G, Szigeti K, Davis E, Wahl M, Nisitani S, Yamashiro J, Le Beau MM, Loda M, Witte ON. Prostate stem cell antigen: a cell surface marker overexpressed in prostate cancer. Proc Natl Acad Sci U S A. 1998 Feb 17;95(4):1735-40. doi: 10.1073/pnas.95.4.1735.
- Background: PubMed 10825005Nupponen NN, Isola J, Visakorpi T. Mapping the amplification of EIF3S3 in breast and prostate cancer. Genes Chromosomes Cancer. 2000 Jun;28(2):203-10.
- Background: PubMed 11074616Nupponen NN, Visakorpi T. Molecular cytogenetics of prostate cancer. Microsc Res Tech. 2000 Dec 1;51(5):456-63. doi: 10.1002/1097-0029(20001201)51:53.0.CO;2-H.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Prostate Cancer, run by National Human Genome Research Institute (NHGRI) 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 4 Mar 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00022919, which also lists 3 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 4 Mar 2008.