Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Aberrant Gene Expression Prostate Carcinoma

This study is ongoing, but not recruiting participants.
Information provided by:
Lahey Clinic Identifier:
First received: March 24, 2009
Last updated: May 22, 2013
Last verified: May 2013

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.

Prostate Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Identification of Aberant Gene Expression in Human Prostatic Carcinoma

Resource links provided by NLM:

Further study details as provided by Lahey Clinic:

Biospecimen Retention:   Samples With DNA

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)
Detailed Description:

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.


Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

patients diagnosed with prostate cancer patients undergoing surgery for suspected prostate cancer but have negative biopsy healthy volunteers - blood sample only


Inclusion Criteria:

  • Diagnosed prostate cancer undergoing prostatectomy
  • Suspicion of prostate cancer undergoing biopsy - negative biopsy
  • Health volunteer (control group) - blood sample for PSA

Exclusion Criteria:

  • Patients not fitting the inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00868803

United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
Principal Investigator: John A Libertino, M.D. Lahey Clinic
  More Information

No publications provided

Responsible Party: John A. Libertino, M.D., Lahey Clinic Identifier: NCT00868803     History of Changes
Other Study ID Numbers: LCID1995-014
Study First Received: March 24, 2009
Last Updated: May 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Lahey Clinic:
prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on February 27, 2015