EMBRACE1: Prostate Biorepository

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Caris Science, Inc.
ClinicalTrials.gov Identifier:
NCT01499381
First received: December 16, 2011
Last updated: March 13, 2013
Last verified: March 2013
  Purpose

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.


Condition
Prostate Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Caris Science, Inc.:

Primary Outcome Measures:
  • Carisome Prostate Assay with prostate biopsy outcome [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    Association of Carisome Prostate Assay result with prostate biopsy outcome


Biospecimen Retention:   Samples With DNA

Plasma


Enrollment: 1290
Study Start Date: December 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Routine prostate biopsy patients

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Men scheduled for routine prostate biopsy

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499381

Locations
United States, Arizona
Caris Science, Inc.
Phoenix, Arizona, United States
Sponsors and Collaborators
Caris Science, Inc.
Investigators
Principal Investigator: Les Paul, MD Caris Science, Inc.
  More Information

No publications provided

Responsible Party: Caris Science, Inc.
ClinicalTrials.gov Identifier: NCT01499381     History of Changes
Other Study ID Numbers: CRMDA-0001-1011
Study First Received: December 16, 2011
Last Updated: March 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014