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| Sponsor: | Lahey Clinic |
|---|---|
| Information provided by: | Lahey Clinic |
| ClinicalTrials.gov Identifier: | NCT00868803 |
Purpose
The goal of the study is to gain a better understanding of the molecular changes responsible for causing prostate cancer and that examination of tissue and blood samples will help in the development of improved screening and therapeutic approaches.
| Condition |
|---|
|
Prostate Cancer |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Identification of Aberant Gene Expression in Human Prostatic Carcinoma |
Surplus tissue following pathologic review requirements will be snap frozen and processed for extraction of RNA. mRNA will be reversed transcribed to make cDNA with the prime 5'TCCTTAGAAC, followed by 40 cycles of palindromic PCR using the sam eprimer. Amplified cDNA (35 S-labled) will be analysed on a 4% polyacrylamide gel. Comparative analysis of cDNA amplified products will serve to identify aberrantly expressed candidate genes. Such products will be isolated, sequenced and evaluated as to their role in establishing the neoplastic pheotype and the potential utility as a marker of prostatic neoplastic progression.
| Estimated Enrollment: | 5000 |
| Study Start Date: | April 1995 |
| Estimated Study Completion Date: | April 2025 |
| Estimated Primary Completion Date: | April 2020 (Final data collection date for primary outcome measure) |
The goal of this study is to identify novel genetic elements that are aberantly expressed throughout prostatic neoplastic progression. The approaches proposed exploit the known familial arm of prostatic cancer, using established molecular genetic approaches, and extend these studies to sporadic prostatic cancer using a novel technique of differential display. Application of the latter technique to colon cancer in the American population establishes this tumor type as a high priority for scientific investigation and this study is part of an initiative to address this problem. Presently the studies in the field of prostate are under-represented. The collection of tissue samples from patients diagnosed with prostate cancer. Patients will also provide a blood sample at the time of their surgery and potentially post-op from 6 mos to 5 years. Samples will also be obtained from patients who's biopsy turns out to be non-prostate cancer. These samples will be obtained shortly following the biopsy out to 6 months after the biopsy.
Eligibility| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
patients diagnosed with prostate cancer patients undergoing surgery for suspected prostate cancer but have negative biopsy healthy volunteers - blood sample only
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: John A Libertino, M.D. | 781-744 ext 2511 | John.A.Libertino@Lahey.org |
| Contact: Linda Topjian, CCRP | 781-744- ext 8711 | Linda.M.Topjian@Lahey.org |
| United States, Massachusetts | |
| Lahey Clinic | Recruiting |
| Burlington, Massachusetts, United States, 01805 | |
| Contact: John A Libertino, M.D. 781-744-2511 ext 2511 John.A.Libertino@Lahey.org | |
| Contact: Linda M Topjian 781-744-8711 ext 8711 Linda.M.Topjian@Lahey.org | |
| Sub-Investigator: David Canes, MD | |
| Sub-Investigator: Alireza Moinzadeh, MD | |
| Principal Investigator: | John A Libertino, M.D. | Lahey Clinic |
More Information
| Responsible Party: | John A. Libertino, M.D., Lahey Clinic |
| ClinicalTrials.gov Identifier: | NCT00868803 History of Changes |
| Other Study ID Numbers: | LCID1995-014 |
| Study First Received: | March 24, 2009 |
| Last Updated: | June 21, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
prostate cancer |
|
Carcinoma Prostatic Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases |