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Evaluation of a Novel Circulating Microvesicle-Based Multi-analyte Assay for the Detection of Prostate Cancer in Men With Elevated Risk for Prostate Cancer; the EMBRACE1 Study


N/A
18 Years
N/A
Not Enrolling
Male
Prostate Cancer

Thank you

Trial Information

Evaluation of a Novel Circulating Microvesicle-Based Multi-analyte Assay for the Detection of Prostate Cancer in Men With Elevated Risk for Prostate Cancer; the EMBRACE1 Study


Inclusion Criteria:



- Men scheduled for a routine prostate biopsy expected to produce a pathology
evaluation and report

- Blood draw within 7 days prior to scheduled prostate biopsy procedure

- Blood draw on the day of but prior to biopsy

Exclusion Criteria:

- Any previous diagnosis of cancer with the exception of non-melanoma skin cancer

- Any prior or ongoing treatment for prostate cancer including prostatectomy or hormone
therapy

- Prostate biopsy within one month of blood draw

- Previous enrollment in the Caris Life Sciences Biorepository

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Carisome Prostate Assay with prostate biopsy outcome

Outcome Description:

Association of Carisome Prostate Assay result with prostate biopsy outcome

Outcome Time Frame:

up to 6 months

Safety Issue:

No

Principal Investigator

Les Paul, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Caris Science, Inc.

Authority:

United States: Institutional Review Board

Study ID:

CRMDA-0001-1011

NCT ID:

NCT01499381

Start Date:

December 2011

Completion Date:

July 2012

Related Keywords:

  • Prostate Cancer
  • Prostatic Neoplasms

Name

Location

Caris Science, Inc.Phoenix, Arizona