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Early Detection Blood Test for Breast Cancer Screening

This study is looking at a new blood test called Syantra, which aims to find breast cancer early. Breast cancer is a common cancer in women, and finding it early can lead to better outcomes. The Syantra test works by analyzing specific information in your blood sample using a software program to potentially detect breast cancer. This study wants to see how well the Syantra test works in women aged 30 to 75 who are already getting routine breast cancer screenings. The goal is to see how accurately the test identifies breast cancer (sensitivity) and how accurately it shows no cancer when none is present (specificity) over three years. We are looking for 2000 women to join this study.

Study design
This is an observational study, meaning you won't receive a new treatment. It's blinded, so some people involved won't know certain details, and it involves 2,000 women.
What's involved
If you join, you will complete a questionnaire and have a blood sample drawn. Your medical records, including imaging, surgery, and pathology results, will also be reviewed.
Compensation
Not stated in the trial record.
Follow-up
The study will track the test's accuracy over three years to see how well it performs.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07219277

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

Recruiting
Not specifiedAges 30–75Observational
Syantra Inc.
~2,000 participants
Updated 2026-03-11 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity
Measured over 3 years
+1 more outcome measured

Conditions

Breast Cancer, Liquid Biopsy, Early Detection

Explore related trials

Breast Carcinoma

Where it's being run

4 sites across 4 states
Arizona1
New York1
Alberta1
United Kingdom1

Who to contact

Site Study Coordinator
[email protected]
480-306-5390
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age ≥ 30 and ≤ 75
Planned MRI (for women who qualify) and/or planned screening mammogram (and/or breast ultrasound)
Presentation of factor(s) indicating elevated risk for breast cancer development
Willing and able to give Written Informed Consent and provide a whole blood sample
Age ≥ 30 and ≤ 75
Previous MRI (for women who qualify) and/or screening mammogram (and/or breast ultrasound) indicating follow-up imaging or biopsy recommended
Presentation of factor(s) indicating elevated risk for breast cancer development
Willing and able to give Written Informed Consent and provide a whole blood sample
Age ≥ 30 and ≤ 75
Planned diagnostic breast imaging (mammogram, breast MRI and/or breast ultrasound) and/or breast biopsy, as recall or follow-up from prior examination or to evaluate breast symptom.
Willing and able to give Written Informed Consent and provide a whole blood sample.
Age ≥ 30 and ≤ 75
Screening mammogram and/or breast ultrasound, breast MRI within 3 months
Willing and able to give Written Informed Consent and provide a whole blood sample

Exclusion

Physical breast symptoms or concerns
Current or suspected cancer diagnosis
Prior BI-RADS 3 or higher imaging results in last 12 months
Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy) within the last 12 months
Previous history of any cancer, except for non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma)
Previous history of invasive or non-invasive breast cancer
Concomitant or other concurrent anti-cancer therapy
Blood transfusions within the past 3 months
Born biologically male
Physical breast symptoms or concerns
Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy) within the last 12 months
Current diagnosis or history of any cancer, including DCIS, with the exception of non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma)
Blood transfusions within the past 3 months
Born biologically male 2. Recall (Secondary care) Symptomatic population: Women recommended for follow-up due to physical symptoms. This includes recommendation for diagnostic imaging and/or biopsy due to physical symptoms.
Current known cancer diagnosis
Breast surgery within the previous 12 months (for any reason) or recent breast biopsy (including needle core biopsy) within the last 12 months
History of any cancer, with the exception of non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma)
Blood transfusions within the past 3 months
Born biologically male 3. Asymptomatic average, low or unknown risk population: Women undergoing routine screening for breast cancer. Women in the Screening population would have no physical symptoms and be consented near the time of a screening imaging session (within 3 months). Recruitment may also occur after a screening imaging session with a recommendation for follow-up imaging, or after diagnostic imaging with a recommendation for a biopsy as part of the recall population.
Physical breast symptoms or concerns
Breast surgery within the previous 12 months (for any reason) or breast biopsy (including needle core biopsy) within the last 12 months
History of any cancer, including DCIS, with the exception of non-melanoma skin cancer (basal cell carcinoma and squamous cell carcinoma)
Blood transfusions within the past 3 months
Born biologically male

What this trial measures

  • Sensitivity3 years

    Sensitivity (Se) if the test = TP/TP+FN), ratio of true positives to true positives and false negatives

  • Specificity3 years

    Specificity (Sp) of the test = TN/ (TN+FP), ratio of true negatives to the true negatives and false positives