Early-detection blood test for breast cancer
Official title: Clinical Validation of Early Detection Blood Test for Universal Large-scale Breast Cancer Screening to Improve Early Diagnosis for Women of All Social and Ethnic Backgrounds
Run by Syantra Inc. · NCT07219277 · Data updated 2026-11-12
This project will try the Syantra blood test to see if it can detect early breast cancer in women aged 30–75 who are having routine screening or planned diagnostic imaging.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 30 Years to 75 Years |
| Sex | Women only |
| Enrollment | 2000 (estimated) |
| Sponsor | Syantra Inc. Industry-sponsored |
| Locations | 4 sites (Phoenix, Arizona and 3 other locations) |
| Status | Recruiting |
| Started | January 7, 2026 |
| Main results expected | June 14, 2027 |
| Study ends | June 14, 2027 |
| Registry record updated | March 11, 2026 |
| Trial ID | NCT07219277 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 30–75 undergoing routine breast screening or planned diagnostic imaging/biopsy, especially those with elevated risk factors (germline mutations, very dense breasts, family history, or high modelled risk), who can give informed consent and provide a blood sample are ideal candidates.
✕Probably not a fit
Women with current breast symptoms or a known or suspected cancer diagnosis, those with prior high-risk imaging findings, or people outside the 30–75 age range are unlikely to benefit from this observational validation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a non-randomized, blinded, non-interventional, longitudinal multi-center validation of the Syantra blood test enrolling up to 2,000 women aged 30–75. Participants provide a baseline questionnaire and a blood sample prior to any planned biopsy or surgery, and their medical records, imaging, and pathology results are reviewed. Outcomes include clinical performance metrics of the test and analysis of how ethnicity, geography, breast density, and elevated-risk features affect performance. Records will be updated after diagnostic workup (within 60 days) and again at 12 months to capture interval cancers and clinical status.
Why it matters
Potential benefit: If successful, the test could increase early detection of breast cancer, leading to earlier treatment and potentially reduced illness and deaths.
How similar studies have gone: Other blood-based and liquid-biopsy approaches have produced promising signals in smaller or early-phase work, but large-scale clinical validation for routine breast screening remains limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
1. Elevated risk population sub-group: Women at elevated risk undergoing routine screening for breast cancer.
A. Asymptomatic Screening Inclusion Criteria
* 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
o Factors may include germline genetic mutations known to increase risk of breast cancer, very dense (D) breast tissue, family history, and/or clinical risk assessment and scoring at elevated risk (20% or greater lifetime risk, or 3% or greater 10-year risk assessed at age 40, using the Tyrer-Cuzick model (v.7 or v.8) or 1.67% or greater 5-year breast cancer risk using the BCSC model
* Willing and able to give Written Informed Consent and provide a whole blood sample
Exclusion Criteria
* 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
B. Recall Inclusion Criteria
* 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
o Factors may include germline genetic mutations known to increase risk of breast cancer, very dense (D) breast tissue, family history, and/or clinical risk assessment and scoring at elevated risk (20% or greater lifetime risk, or 3% or greater 10-year risk assessed at age 40, using the Tyrer-Cuzick model (v.7 or v.8) or BOADICEA v6.0 or 1.67% or greater 5-year breast cancer risk using the BCSC model.
* Willing and able to give Written Informed Consent and provide a whole blood sample
Exclusion Criteria
* 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.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
Inclusion Criteria
* 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 Criteria
* 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
Where it's running
-
Vincere Cancer Center
Phoenix, Arizona, United States Recruiting -
Weill Cornell Medicine of Cornell University
New York, New York, United States Not yet recruiting -
Alberta Cancer Research Biobank
Calgary, Alberta, Canada Active not recruiting -
Manchester University NHS Foundation Trust
Manchester, United Kingdom Not yet recruiting
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.