RecruitingOBSERVATIONAL

A Study to Identify Breast Cancer (IDBC)

This research project is looking at a new blood test, called Syantra DX Breast Cancer, designed to help find breast cancer. Finding cancer early often leads to better treatment results, and this test aims to make that process simpler and less invasive than current methods. The study will collect blood samples from women who are having a mammogram, including those with normal results and those where something unusual was found. By comparing the blood test results with standard diagnostic methods, researchers want to check how accurate and reliable this new test is. The goal is to see if this blood test could be a useful tool alongside mammograms to detect breast cancer earlier in the future.

At a glance

Status

Recruiting

Sponsor

Syantra Inc.

Enrolment target

10,000

Start

24 Jan 2019

Estimated completion

31 Dec 2032

Breast Cancer Female

What is this study about?

This study is about a new blood test called Syantra DX Breast Cancer, which aims to help detect breast cancer. Doctors and researchers know that finding breast cancer as early as possible is really important for getting the best outcomes from treatment. Currently, finding breast cancer often involves mammograms, and sometimes follow-up tests like biopsies if something suspicious is found.

This new blood test works by looking at special patterns in your blood that might indicate breast cancer. These patterns are like tiny clues in your genes. The test uses a special computer program to analyse these clues and decide if breast cancer might be present. Up until now, the test has shown promising results when used on blood samples collected in the past. This new study is an important next step to see how well it works with fresh blood samples from women today.

The main goal of this study is to carefully check if the Syantra DX Breast Cancer test is accurate and reliable when used in real-life situations. To do this, researchers will compare the results from the blood test with the results from standard diagnostic methods, like mammograms and biopsies. They hope that if this test proves to be accurate, it could eventually help women who are having breast cancer screening or who need further checks after an abnormal mammogram, potentially making diagnosis quicker and less stressful.

Key takeaways

This study is testing a new blood test for early breast cancer detection.
It aims to make diagnosis simpler and potentially quicker for women.
Participants provide a single blood sample, usually around the time of a mammogram.
The study is for research; individual blood test results are not provided to participants.
Your involvement could help improve breast cancer detection methods for the future.

Who may be eligible?

To join this study, you need to be a woman between the ages of 30 and 75.

We are looking for women in two main groups. The first group includes women who have had an abnormal mammogram that suggests either benign (harmless) breast changes or that breast cancer might be present. The second group includes women who have had a normal physical breast examination and either a normal mammogram or one that shows only benign changes, with no past history of breast cancer.

You cannot join if you have been diagnosed with any type of cancer before, or if you've had breast surgery or a breast biopsy in the last 12 months. Also, men cannot take part in this study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged between 30 and 75 years?
Have you had a normal breast exam (no cancer suspected)?
Have you had an abnormal mammogram that suggests something suspicious or benign changes?
OR, have you had a recent normal mammogram and physical breast exam, with no history of breast cancer?
Have you NOT had any type of cancer diagnosis before?
Have you NOT had breast surgery or a breast biopsy in the last 12 months?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will be asked to provide a blood sample. This blood sample will be taken around the same time as your screening mammogram or any follow-up appointments for an abnormal mammogram. For those with an abnormal mammogram, the blood sample will be taken before any biopsy procedures are done.

The blood sample will be analysed in a lab using the Syantra DX Breast Cancer test. The researchers will not know your personal details or your mammogram results when they test your blood, to keep the process fair and unbiased. Your participation involves one visit to give a blood sample, and there are no ongoing appointments or medication involved in this specific study. The total duration of your involvement is simply the time it takes to provide your blood sample.

Potential risks and benefits

Taking part in this study carries very few risks, mainly those associated with a standard blood draw, such as a small bruise or slight soreness where the needle went in. You will not receive your individual blood test results from this study, as it is purely for research to validate the test itself. The potential benefit is that your participation helps researchers develop a new tool that could eventually improve breast cancer detection for many women in the future, potentially leading to earlier diagnoses. You are free to withdraw from the study at any time without giving a reason, and it will not affect your medical care.

Locations (4)

Alberta Cancer Research Biobank
Verified postcode
Calgary, Canada· Recruiting
Severance Hospital
Verified postcode
Soeul, South Korea· Completed
North Manchester General Hospital
Verified postcode
Manchester, United Kingdom· Recruiting
Wythenshawe Hospital, Southmoor Road
Verified postcode
Manchester, United Kingdom· Recruiting

Common questions

What is the Syantra DX Breast Cancer test?

It's a new blood test being developed to help find breast cancer early by looking at special patterns in your blood.

Will I get my test results?

No, this is a research study to check the test's accuracy. You will not receive individual results from the blood test you provide.

Do I need to do anything special to prepare?

No, you don't need any special preparation for the blood test. It's a routine blood draw.

How long will I be involved in the study?

Your involvement is limited to a single visit to provide a blood sample.

Is this test a replacement for mammograms?

No, not at this stage. This study is exploring if it can be a useful tool alongside mammograms to help with early detection.

How to find out more

Natasha Jones

natasha.jones@mft.nhs.uk 0161 291 4045 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.