Clinical Trial Details
— Status: Not yet recruiting
Administrative data
NCT number |
NCT05813041 |
Other study ID # |
BioCaptis-1 |
Secondary ID |
|
Status |
Not yet recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
July 31, 2023 |
Est. completion date |
September 30, 2023 |
Study information
Verified date |
July 2023 |
Source |
BioCaptiva Ltd. |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Liquid biopsy is a new field in medicine where doctors can look at small molecules in our
blood, called DNA, that carry the genetic material that makes us who we are. In some
illnesses this DNA starts behaving abnormally, meaning that these illnesses can be identified
by looking closely at changes in a person's DNA.
The BioCaptis is a new medical device which can capture molecules of DNA, called cell-free
DNA, from a person's blood when used in a clinical procedure called apheresis. The purpose of
the BioCaptis-1 clinical trial is to confirm that the BioCaptis is suitable for use in
healthy volunteers. The main questions the study aims to answer are:
- Is the BioCaptis safe to use in healthy volunteers?
- Can the BioCaptis capture cell-free DNA from human plasma when used in an apheresis
procedure?
Following completion of the informed consent process, participants in the study will complete
six appointments over the course of the trial. Three of these will be telephone appointments,
and three will be in-person visits at the clinical site. The three in-person visits will
include:
- Screening Visit where screening tests will be performed to deem the participant suitable
for enrollment;
- Procedural Visit during which the participant will undergo the apheresis procedure with
the BioCaptis device;
- Post-procedure Follow Up Visit to check the particpant's health following the apheresis
procedure.
Description:
Personalised medicine is a medical model which has developed rapidly in recent years, and it
involves tailoring treatment plans to individual patients based on the type of disease they
have and how they are expected to respond to certain treatment types. To develop personalised
treatment plans for cancer patients, doctors look at a piece of tumour tissue taken from the
patient which is called a biopsy. Doctors will examine this biopsy to identify genetic
abnormalities which help to explain the behaviour of that tumour or indicate how that tumour
could respond to certain anti-cancer treatments. This is called "molecular profiling."
Although tissue biopsy is widely used for molecular profiling, it has some drawbacks.
Firstly, tissue biopsy is a highly invasive procedure which can cause stress to patients.
Secondly, some biopsies are performed using a small needle, and due to the small size of this
needle the tumour tissue can be missed meaning that there is no tumour tissue present in the
sample to carry out necessary tests. Thirdly, tissue biopsy can't be used for real-time
monitoring of cancers because multiple biopsies would be required from a patient over the
course of their treatment which would cause additional stress and discomfort to them. So, an
alternative biopsy method is needed to address these limitations.
A new field in medicine called "liquid biopsy" is becoming very popular. This is where a
doctor can use a blood sample to diagnose an illness instead of having to take a tissue
biopsy. Liquid biopsy works by looking at very small molecules in our blood, called DNA, that
carry the genetic material that makes us who we are. In some illnesses this DNA starts
behaving abnormally, meaning that these illnesses can be identified by looking closely at a
person's DNA. One illness that liquid biopsy has the potential to identify is cancer because
DNA from all the body's cells, including cancer cells, can be found in the blood stream.
Doctors can then use this information to choose a treatment plan for the patient. Although it
shows promise for use in molecular profiling, development of liquid biopsy has been held back
because the amount of DNA that can be collected using a regular blood draw (the kind used in
a doctor's surgery) is very low and does not give reliable results when used in laboratory
tests. To address this limitation, BIOCAPTIVA has developed a medical device called the
BioCaptis which is a small tube that has a special filter in it. The filter can capture up to
100 times more cfDNA than a regular blood sample when it is used during an apheresis
procedure.
An apheresis procedure is a routine and safe process used to treat patients with a range of
conditions. It is also used to collect blood cells from healthy donors that can then be used
to treat sick patients. It works by connecting a patient or healthy donor to a machine. Blood
flows from the person into the machine where it is then separated out into its main parts.
The part of the blood that is causing the patient's condition, or contains the cells that can
be used to treat patients, is removed and everything else is returned back to the person.
Apheresis is a well-tolerated procedure, but as with all procedures there is some risk. The
most commonly observed side effects are listed below:
- Bruising can occur at the needle puncture site.
- Sometimes the blood vessel that the needle has been placed in goes into spasm, so the
blood flow slows down.
- A blood thinner is added into the machine to stop the person's blood from clotting while
it is outside of their system. Some of it flows back into their system with the blood
being returned which can cause tingling around the mouth or fingertips, or cause
shivering.
The BioCaptis-1 study has been designed to confirm that the BioCaptis device is both safe to
use and able to capture DNA from the blood of human subjects when used with an apheresis
procedure. In this clinical trial, we will use an apheresis machine in combination with the
BioCaptis device. The participant's plasma will pass through the BioCaptis and the filter
inside the device will capture the DNA in the participant's plasma. Their plasma will then be
combined with the rest of their blood and be returned to them.
As this is a completely new device, no similar research on this topic has been done before.