Prostate CancerNCT01499381
EMBRACE1: Prostate Biorepository
An observational study of Prostate Cancer, run by Caris Science, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- How many people
- 1,290 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2011to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Men scheduled for routine prostate biopsy
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Routine prostate biopsy patients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carisome Prostate Assay with prostate biopsy outcome
Association of Carisome Prostate Assay result with prostate biopsy outcome
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2011 (estimated)
- Study startDec 2011
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caris Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01499381
- Sponsor's protocol ID
- CRMDA-0001-1011
- Status last verified
- Jun 2016
- First submitted
- 16 Dec 2011
- Last updated
- 9 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01499381
- Acronym / sponsor ID
- CRMDA-0001-1011
- Conditions
- Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,290 participants (actual)
- Lead sponsor
- Caris Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 26 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Routine prostate biopsy patients | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men scheduled for routine prostate biopsy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Carisome Prostate Assay with prostate biopsy outcome
Time frame: up to 6 months
Association of Carisome Prostate Assay result with prostate biopsy outcome
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer, run by Caris Science, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Carisome Prostate Assay with prostate biopsy outcome (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2016.