Angle PLC has recruited the first patient for its European ovarian cancer trial (ANG-001), which aims to enroll 200 women diagnosed with a pelvic mass via imaging studies who are scheduled to undergo surgery to remove their tumors.
Patients’ blood will be examined with the Parsortix system, which enables the cells of interest to be acquired using a simple blood test, and RNA from the cell harvests of patients will be assessed to identify the presence or absence of ovarian circulating tumor cells (CTCs).
Patient enrollment is expected to be complete by the end of the year.
The four cancer clinical centers that are actively recruiting patients include the Medical University of Vienna, which will lead the trial, analyzing samples from the patients and optimizing RNA markers; Charité – Universitätsmedizin Berlin; the Vivantes Network for Health GmbH with the Department of Gynecology, Hospital Neukölln; and the Vivantes Network for Health GmbH with the Clinic for Gynecology and Obstetrical Medicine in the Klinikum Auguste Viktoria.
The first half of patients enrolled in the trial will be used to establish which of the RNA markers previously investigated are best to identify ovarian cancer CTCs harvested by the Parsortix system. The remaining patients will validate if those RNA markers are successful to distinguish between women with benign and cancerous pelvic masses.
Angle’s Parsortix system uses a patented micro-fluidic technology in the form of a disposable cassette to capture and harvest circulating tumor cells from blood. The cassette captures CTCs based on their less deformable nature and larger size compared to other blood components. The cassette is then placed in a clamp and the Parsortix system automatically processes patient samples.
If the study is successful, Angle could offer its Parsortix system to qualified European hospitals where a laboratory-developed test (LDT) based on the RNA indicators identified would be able to evaluate the cancerous status of patients before surgery for abnormal pelvic mass.
Andrew Newland, Angle founder and chief executive, said in a press release that the company has made a huge effort to get the study up and going.
“The four participating centers are enthusiastic and committed, and we look forward to the next stage of development of this important clinical application,” he said.
Angle is also planning a similar study in the United States.
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