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Home > "A" Clinical Trials Conditions > Analysis of Prostate Cancer Short-Term Cultures Using Molecular Cytogenetic Methods  Analysis of Prostate Cancer Short-Term Cultures Using Molecular Cytogenetic Methods
Analysis of Prostate Cancer Short-Term Cultures Using Molecular Cytogenetic Methods
For Condition: Prostate Cancer
Status: Recruiting
Sponsor(s): National Human Genome Research Institute (NHGRI) ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Male
Protocol Entry Criteria: INCLUSION CRITERIA: 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. EXCLUSION CRITERIA: No prisoners, decisionally impaired, healthy volunteers, or lab personnel will be included in this study.
Total Enrollment: 150
Location and Contact Information:
National Human Genome Research Institute (NHGRI) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 010212; 01-HG-0212
Study Start Date: August 6, 2001
Record last reviewed: July 17, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00022919
Other Prostate Cancer Studies:
1. Clinical Trial for Prostate Cancer
2. "REDUCE" - A Clinical Research Study To Reduce The Incidence Of Prostate Cancer In Men Who Are At Increased Risk
3. Open-label Trial on the Effect of I.V. Zometa 4 mg on Bone Density in Hormone Sensitive Prostate Cancer Patients with Bone Metastasis
4. Facilitating Shared Decisionmaking About Prostate Cancer Screening
5. Study Of MEDI-522 In Combination With Docetaxel ± Low-Dose Estramustine And Zoledronic Acid In The Treatment Of Patients With Androgen-Independent Prostate Cancer That Has Metastasized To Bone
Related Studies:
Other Prostate Cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Analysis of Prostate Cancer Short-Term Cultures Using Molecular Cytogenetic Methods
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