A blood test for breast cancer? the future of screening may be in your vein

NCT ID NCT04495244

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 19, 2026 · Last updated Aug 20, 2026 · Updated 1 time

Summary

This study is testing a new blood test, called Syantra DX Breast Cancer, to see if it can accurately identify the presence of breast cancer. The test looks for specific genetic markers in the blood that may indicate cancer. Researchers will compare the test results with standard imaging and biopsy results from 10,000 women to determine its accuracy. If proven reliable, this could offer a less invasive and more accessible screening option for breast cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Syantra DX Breast Cancer blood test
What this could lead to
If successful, this blood test could become a routine, less invasive screening tool to catch breast cancer earlier, potentially improving survival rates.
What could go wrong
The test is still being validated in a large, real-world setting. It may not be accurate enough to replace mammograms, and false positives or negatives remain possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 10,000 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2019

Expected to finish

Dec 2032

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Populations will be selected from women visiting the actively recruiting sites for breast cancer screening.

Ages

30 to 75 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria * Aged 30-75 years * Normal breast examination - No cancer detected/suspected by physical exam, diagnostic radiology or screening mammography * Women with suspected Invasive Breast Cancer * Individuals with an abnormal or suspicious mammogram * Abnormal screening mammogram with suspected benign breast disease or proliferative changes Exclusion criteria * Cancer diagnosis * Male * Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy) * Previous history of any cancer * Concomitant or other concurrent anti-cancer therapy * Inoperable or inflammatory breast cancer

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    3 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Alberta Cancer Research Biobank

    RECRUITING

    Calgary, Alberta, Canada

  • North Manchester General Hospital

    RECRUITING

    Manchester, M23 9LT, United Kingdom

  • Severance Hospital

    COMPLETED

    Soeul, South Korea

  • Wythenshawe Hospital, Southmoor Road

    RECRUITING

    Manchester, M23 9LT, United Kingdom

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