EMBRACE1: Prostate Biorepository

NCT ID: NCT01499381

Last Updated: 2016-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1290 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Routine prostate biopsy patients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Caris Science, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Caris Science, Inc.

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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CRMDA-0001-1011

Identifier Type: -

Identifier Source: org_study_id

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