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Aberrant Gene Expression Prostate Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00868803
Recruitment Status : Active, not recruiting
First Posted : March 25, 2009
Last Update Posted : December 2, 2021
Information provided by (Responsible Party):
Linda Topjian, Lahey Clinic

Brief Summary:
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 or disease
Prostate Cancer

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.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Identification of Aberant Gene Expression in Human Prostatic Carcinoma
Study Start Date : April 1995
Estimated Primary Completion Date : April 2025
Estimated Study Completion Date : April 2025

Resource links provided by the National Library of Medicine

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00868803

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United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
Sponsors and Collaborators
Lahey Clinic
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Principal Investigator: Kimberly R Christ, PhD Lahey Clinic
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Responsible Party: Linda Topjian, study coordinator, Lahey Clinic Identifier: NCT00868803    
Other Study ID Numbers: LCID1995-014
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: December 2, 2021
Last Verified: December 2021
Keywords provided by Linda Topjian, Lahey Clinic:
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases