Angle initiates 200 patient European ovarian cancer study
Medical technology company Angle’s European ovarian cancer study has been formally initiated with a first patient recruited.
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Angle completed the process required to initiate this study, which included optimising the system protocols for the application, development and approval of the study plan and data collection.
ANG-001, the 200-patient ovarian cancer study, analyses blood using the Parsortix system and ribonucleic acid from cell harvests are evaluated to detect the presence or absence of ovarian circulating tumour cells. The aim is to discriminate successfully between women with benign and malignant masses as confirmed by the histopathological examination of the tissue post-surgery.
The four centres participating in the study are primarily in Austria and Germany and they are currently recruiting patients.
They centres are Medical University of Vienna, Charité Universitätsmedizin Berlin which is one of the largest university hospitals in Europe, the Vivantes network for health with the clinic for gynecology and obstetrical medicine in Klinikum Auguste Viktoria; and the Vivantes network for health with the department of gynecology at Hospital Neukölln.
Chief executive Andrew Newland said: "It has been a huge effort to put this clinical study in place and we are now excited to see the study in progress. The four participating centres are enthusiastic and committed and we look forward to the next stage of development of this important clinical application."
The first half of patients enrolled into the ANG-001 study will be used as a training set to determine which of the ribonucleic acid markers are optimal for the detection of ovarian cancer circulating tumour cells harvested by the Parsortix system. The remainder will be used as a verification set.
The AIM listed company said a successful completion of the ANG-001 study would enable the company to offer the Parsortix system to accredited European hospitals where a laboratory developed test would be able to be designed.
Angle aims to complete the study by the end of the year and conduct a similar a study in the US later.
It estimated that the global market for the presurgical assessment of ovarian cancer risk could be over of £300m per year.
Shares in Angle fell 0.08% to 66.05p at 1336 BST.