NCT00868803

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
47mo left

Started Apr 1995

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Apr 1995Apr 2030

Study Start

First participant enrolled

April 1, 1995

Completed
14 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
21 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

June 5, 2025

Status Verified

June 1, 2025

Enrollment Period

35 years

First QC Date

March 24, 2009

Last Update Submit

June 2, 2025

Conditions

Prostate Cancer

Keywords

prostate cancer

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lahey Clinic

Burlington, Massachusetts, 01805, United States

Location

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.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Kimberly R Christ, PhD

    Lahey Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
study coordinator

Study Record Dates

First Submitted

March 24, 2009

First Posted

March 25, 2009

Study Start

April 1, 1995

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Last Updated

June 5, 2025

Record last verified: 2025-06

Locations

US(1)