Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00022919
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2001-08-16
Brief Title:
Analysis of Prostate Cancer Short-Term Cultures Using Molecular Cytogenetic Methods
Sponsor:
National Human Genome Research Institute NHGRI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Analysis of Prostate Cancer Short-Term Cultures Utilizing Molecular Cytogenetic Methods
Status:
COMPLETED
Status Verified Date:
2004-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 01-HG-0212 | None | None | None |