Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting study, sponsored by Sequenom.
NCT07543757 is a clinical trial that is actively recruiting participants, run by Sequenom. The registered enrollment target is 500 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Evaluate Proclarix®'s clinical performance, specifically NPV to predict the absence of csPCa on prostate biopsy.
Interventions
- DIAGNOSTIC_TEST Proclarix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 500 participants |
| Start Date | 2026-04-03 |
| Est. Completion | 2027-03-31 |
What NCT07543757 shows while recruiting
NCT07543757 is an observational study that tracks outcomes without assigning an intervention. The registered 500 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Proclarix is the first listed.
NCT07543757 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00001230 · 500 participants
Host Response to Infection and Treatment in Filarial Diseases
- NCT00001529 · 500 participants
Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
- NCT00697411 · 500 participants
Study of Selected X-Linked Disorders: Aicardi Syndrome
- NCT00903110 · 500 participants
Global Patient Registry to Monitor Long-term Safety and Effectiveness of Increlex® in Children and Adolescents With Severe Primary Insulin-like Growth Factor-1 Deficiency (SPIGFD).
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI