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Clinical Validation of Early Detection Blood Test for Universal Large-scale Breast Cancer Screening

This study is looking into a new blood test called Syantra, which aims to find breast cancer at an early stage. Catching breast cancer early is very important for better treatment results. Researchers want to see how well this blood test works in women aged 30 to 75 who are already having regular breast cancer checks or follow-up scans. The study will also explore if things like background, location, or individual health factors (like breast density or a higher risk of breast cancer) affect how accurate the test is. Participants will have a blood sample taken and complete a short questionnaire. They won't need to do anything else after this initial visit.

At a glance

Status
Recruiting
Sponsor
Syantra Inc.
Enrolment target
2,000
Start
07 Jan 2026
Estimated completion
14 Jun 2027

What is this study about?

Breast cancer is a common illness that affects many women across the world. Finding breast cancer early is really important because it often leads to better outcomes from treatment. This study is exploring a new type of blood test, called Syantra, which has been developed over the last ten years.

The Syantra test works by looking at special information in a blood sample. This information is then put through a computer program that helps to identify if breast cancer might be present. The main aim of this study is to see how accurate this new blood test is at finding breast cancer in women aged between 30 and 75. It also wants to understand if personal factors like someone's background, where they live, or specific health details (such as dense breast tissue or a higher chance of developing breast cancer) influence how well the test performs.

This study is important because if the Syantra test proves to be effective, it could help doctors find breast cancer earlier in more women. This could potentially lead to quicker treatment and better health for many people.

Key takeaways

  • The study is testing a new blood test (Syantra) for early breast cancer detection.
  • It aims to find breast cancer earlier, which can lead to better treatment outcomes.
  • Participants are women aged 30-75 who are already undergoing breast cancer screening.
  • Involves one visit for a blood sample and questionnaire; no further action required from participants.
  • This is a research study; the test results will not be used for your direct care.
  • Could help improve future breast cancer screening methods generally.

Who may be eligible?

You might be able to take part in this study if you are a woman aged between 30 and 75 years old.

You would need to be already scheduled for routine breast cancer screening, such as a mammogram or MRI, or follow-up scans because of previous test results. You should also have an increased risk of breast cancer, which could be due to factors like certain genetic changes, very dense breast tissue, a family history of breast cancer, or if your doctor has assessed you as having a higher lifetime risk.

You would not be able to join if you currently have breast symptoms, have been diagnosed with cancer recently, have had certain breast imaging results in the last year, have had breast surgery or a breast biopsy in the past year, or have a history of other cancers (except for non-melanoma skin cancer) or previous breast cancer. You also can't have had a blood transfusion in the last three months or be receiving anti-cancer treatment.

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.

  1. Are you a woman aged between 30 and 75 years old?
  2. Are you already scheduled for routine breast screening or follow-up scans?
  3. Do you have a higher risk of breast cancer (e.g., family history, dense breasts, certain genes)?
  4. Do you NOT have any current breast symptoms or a recent cancer diagnosis?
  5. Have you NOT had breast surgery or a biopsy in the last 12 months?
  6. Have you NOT received a blood transfusion in the last 3 months?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first need to read and sign a consent form, which explains everything about the study. You'll then fill out a questionnaire about your health history and a blood sample will be taken. This blood sample will be taken before any scheduled breast procedures, if you have one. You won't need to take any medication specifically for this study.

After your initial visit, you won’t have to do anything else. The study team will then look at your medical records to gather information about your health, including results from any imaging scans, surgeries, or other tests you've had. They will review and update this information within 60 days of your blood sample and again 12 months later.

For some participants, if their records are not fully complete, the team might continue to review their medical information annually for up to 5 years. Your blood sample, after personal details are removed so it can't be traced back to you, might be stored for up to 20 years for future research.

Potential risks and benefits

Taking part in this study won't directly improve your health, as the test is currently for research and won't change your usual care. However, it could help doctors learn more about finding breast cancer earlier in the future, which could benefit many women. The main risk involves having a blood test, which might cause slight discomfort, bruising, or a small risk of infection. You are free to change your mind and withdraw from the study at any time without giving a reason, and this won't affect your medical care.

Locations (4)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Vincere Cancer Center
    Verified postcode
    Phoenix, United States· Recruiting
  • Weill Cornell Medicine of Cornell University
    Verified postcode
    New York, United States· Not yet recruiting
  • Alberta Cancer Research Biobank
    Verified postcode
    Calgary, Canada· Active not recruiting
  • Manchester University NHS Foundation Trust
    Verified postcode
    Manchester, United Kingdom· Not yet recruiting

Common questions

What is the new blood test called?

The new blood test being studied is called Syantra.

What is the main goal of this study?

The main goal is to find out how well the Syantra blood test can detect breast cancer early.

Will I get my test results from the Syantra blood test?

No, this is a research study, and the test results will not be given to you or used for your treatment.

What do I need to do if I join the study?

You will sign a consent form, fill out a health questionnaire, and have a blood sample taken. That's all you'll need to do.

Who can take part in this study?

Women aged 30-75 who are already having regular breast cancer checks or follow-up scans and have a higher risk of breast cancer.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Clinical Validation of Early Detection Blood Test for Univer…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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