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NCT07543757 · ClinicalTrials.gov registry record
Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix
A clinical trial, sponsored by Sequenom.
- Recruiting
- Registry status
- 500
- Enrollment target
NCT07543757 is a clinical trial that is actively recruiting participants, run by Sequenom. The registered enrollment target is 500 participants.
The verdict
NCT07543757 is actively recruiting participants, sponsored by Sequenom.
- RECRUITING
- Registry status
- 500 participants
- Enrollment target
Study Summary
The study is a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent and prior to the scheduled prostate biopsy (≤30 days), up to 20 mL of whole blood will be collected from each subject. The samples will be blinded and sent to Labcorp for evaluation using the Proclarix® assay. Prostate biopsy will be performed according to standard clinical practice of the urologist (systematic, targeted, or combined biopsy with a transrectal or transperineal approach with or without prior magnetic resonance imaging (MRI)). A minimum of 10 cores are required. Histopathological examination of the biopsy specimen will be performed according to the established local practice. A csPCa is defined as ISUP Grade Group ≥2 detected on biopsy. The assay results will be compared to the biopsy results.
Interventions
- DIAGNOSTIC_TEST Proclarix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2026-04-03 |
| Est. Completion | 2027-03-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07543757
The ClinicalTrials.gov registry entry for NCT07543757 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 500 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sequenom, which has 26 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Proclarix is the first listed.
NCT07543757 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07543757 about?
NCT07543757 is a clinical study titled "Prostate Cancer Risk Identification in a Multi-Ethnic Cohort: a Prospective US-based Multi-center Validation Study of Proclarix". The study is a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent and prior to the scheduled prostate biopsy (≤30 days), up to 20 mL of whole blood will be collected from each subject. The samples will be blinded and se...
What is the current status of trial NCT07543757?
This trial is currently recruiting. The enrollment target is 500 participants. The study started on 2026-04-03. Estimated completion is 2027-03-31.
What interventions are being tested in trial NCT07543757?
The interventions under investigation include: Proclarix (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT07543757?
This trial is sponsored by Sequenom, which has 26 total clinical trials registered on ClinicalTrials.gov.
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