NCT00584792

Brief Summary

This is a single center pilot study to asses the feasibility of conducting a larger population-based study. It is an investigator-initiated study funded yb the UC Davis Cancer Center's Development Award Program. The hypothesis is that the percent african ancestry in an individual may determine their prognosis if diagnosed with prostate cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2006

Status
completed

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 Start

First participant enrolled

August 1, 2006

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 2, 2008

Completed
Last Updated

January 2, 2008

Status Verified

December 1, 2007

Enrollment Period

1.3 years

First QC Date

December 22, 2007

Last Update Submit

December 22, 2007

Conditions

Prostate Cancer

Keywords

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

  • Is there a difference in ancestry percentage between the controls (no cancer) and the cases (prostate cancer)

    12 months

Study Arms (2)

1

Controls (No prostate cancer)

2

Cases (Prostate Cancer Diagnosed)

Eligibility Criteria

Age35 Years - 75 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

African American males between the ages of 35 and 75.

You may qualify if:

  • Self-identification as a male with African ancestry Between ages of 35-75

You may not qualify if:

  • No African ancestry Not between ages of 35-75

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITH DNA

Serum collected for Ancestry Imformative Markers (AIMS) testing along with PSA and CRP.

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lesley Butler, PhD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2007

First Posted

January 2, 2008

Study Start

August 1, 2006

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

January 2, 2008

Record last verified: 2007-12