BioCaptis-1
Research type
Research Study
Full title
A single-site, first-in-human trial to assess the safety and performance of a novel device, the BioCaptis, for capturing cell-free DNA (cfDNA) in healthy human subjects when used in an apheresis circuit.
IRAS ID
324476
Contact name
James Griffin
Contact email
Sponsor organisation
BICAPTIVA Limited
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 3 months, 29 days
Research summary
Liquid biopsy is becoming very popular, and it works by looking at very small molecules in our blood, called DNA, that carry genetic material that makes us who we are. In some illnesses this DNA behaves abnormally, and these illnesses can be identified by looking closely at a person’s DNA.
Liquid biopsy has the potential to identify cancer because DNA from cancer cells can be found in the bloodstream. This means that doctors could use a blood sample to test for cancer, rather than having to take a piece of abnormal tissue (a biopsy) which can sometimes only be done by operation.
Unfortunately, very low amounts of DNA can be obtained from a regular blood sample, and this has limited developments in liquid biopsy. BIOCAPTIVA has developed a medical device called the BioCaptis, which is a small tube that contains a special filter which can capture DNA. Pre-clinical research has shown that using the BioCaptis during a clinical procedure called apheresis can deliver much higher quantities of DNA than can be obtained from a regular blood sample. The BioCaptis is a novel device and has not yet been tested on humans and in a clinical setting. The purpose of this study is therefore to confirm that the device is safe for use, and that it’s able to capture DNA which can be used for laboratory testing.
Healthy volunteers will be used in this study to assess safety parameters. Following screening procedures, eligible subjects will each undergo an apheresis procedure with the BioCaptis. The effect of the apheresis procedure on each subject will be reviewed to confirm that the device is safe; and we will look at the quantity and quality of the DNA captured by the BioCaptis to confirm that the DNA can be used in laboratory testing.
REC name
South East Scotland REC 02
REC reference
23/SS/0018
Date of REC Opinion
3 Apr 2023
REC opinion
Further Information Favourable Opinion