EMBRACE1: Prostate Biorepository

June 7, 2016 updated by: Caris Science, Inc.

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

The objective of this multi-center prospective observational clinical study is to evaluate the clinical performance of the Carisome Prostate assay as an aid in the diagnosis of prostate cancer in men that have been scheduled for a prostate biopsy. Primarily, results of the Carisome Prostate assay will be compared with pathology results of prostate biopsy procedures. Secondarily, the performance of the Carisome Prostate test will be compared to the current standard of care for the detection of prostate cancer.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1290

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States
        • Caris Science, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Probability Sample

Study Population

Men scheduled for routine prostate biopsy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Routine prostate biopsy patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Carisome Prostate Assay with prostate biopsy outcome
Time Frame: up to 6 months
Association of Carisome Prostate Assay result with prostate biopsy outcome
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Caris Science, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

December 16, 2011

First Submitted That Met QC Criteria

December 23, 2011

First Posted (Estimate)

December 26, 2011

Study Record Updates

Last Update Posted (Estimate)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 7, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRMDA-0001-1011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostate Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe