Aberrant Gene Expression Prostate Carcinoma

Sponsor
Lahey Clinic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00868803
Collaborator
(none)
5,000
1
360
13.9

Study Details

Study Description

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 Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    5000 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Identification of Aberant Gene Expression in Human Prostatic Carcinoma
    Study Start Date :
    Apr 1, 1995
    Anticipated Primary Completion Date :
    Apr 1, 2025
    Anticipated Study Completion Date :
    Apr 1, 2025

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      N/A and Older
      Sexes Eligible for Study:
      Male
      Accepts Healthy Volunteers:
      Yes
      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

      Locations

      Site City State Country Postal Code
      1 Lahey Clinic Burlington Massachusetts United States 01805

      Sponsors and Collaborators

      • Lahey Clinic

      Investigators

      • Principal Investigator: Kimberly R Christ, PhD, Lahey Clinic

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Linda Topjian, study coordinator, Lahey Clinic
      ClinicalTrials.gov Identifier:
      NCT00868803
      Other Study ID Numbers:
      • LCID1995-014
      First Posted:
      Mar 25, 2009
      Last Update Posted:
      Dec 2, 2021
      Last Verified:
      Dec 1, 2021
      Keywords provided by Linda Topjian, study coordinator, Lahey Clinic
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Dec 2, 2021