Clinical trials

This specimen collection is designed to obtain whole blood and tumor tissue from subjects diagnosed with cancer for the purpose of the development of a noninvasive liquid biopsy assay using next generation sequencing (NGS).

The study is a prospective, multi-center, single cohort study involving up to 10 urological clinics in the US. After provision of informed consent, 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. If a prostate biopsy is performed, it 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 is required if a systematic biopsy is performed. 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 specimen collection is designed for the purpose of the development of a noninvasive prenatal test for T21.

Women pregnant between 11-14 weeks gestation will be enrolled with blood samples collected to evaluate for preeclampsia.