Blood test for early breast cancer detection in women 30-75
Official title: Investigation of a Novel Blood Test to Identify Breast Cancer (IDBC)
Run by Syantra Inc. · NCT04495244 · Data updated 2026-11-12
A blood test called Syantra DX Breast Cancer is being tested to see if it can help detect breast cancer early in women who are screened or have abnormal mammograms.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 30 Years to 75 Years |
| Sex | Women only |
| Enrollment | 10000 (estimated) |
| Sponsor | Syantra Inc. Industry-sponsored |
| Locations | 4 sites (Calgary, Alberta and 3 other locations) |
| Status | Recruiting |
| Started | January 24, 2019 |
| Main results expected | December 31, 2032 |
| Study ends | December 31, 2032 |
| Registry record updated | August 19, 2026 |
| Trial ID | NCT04495244 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 30-75 who are undergoing screening or evaluation for possible breast cancer, with various mammography results.
✕Probably not a fit
Women with a diagnosed cancer at enrollment or those not expected to benefit from a blood-based detection approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study validates the performance of the Syantra DX Breast Cancer test using prospective blood samples from women undergoing breast cancer screening or evaluation. The test analyzes gene expression from whole blood to classify a sample as positive or negative for breast cancer using a multi-biomarker panel and proprietary algorithms. Recruitment targets women around the time of screening mammography, including those with abnormal results and those with normal findings, to determine test performance across varied diagnostic categories. The study will compare the test results with imaging, pathology, and clinical data to optimize methodology and biomarkers. The project builds on prior retrospective data and aims to establish prospective utility in a screening/call-back setting.
Why it matters
Potential benefit: If successful, the test could provide a noninvasive blood-based option to help detect breast cancer earlier.
How similar studies have gone: Past retrospective data suggest the approach may identify cancer signals, but prospective validation remains essential for confirmation.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Alberta Cancer Research Biobank
Calgary, Alberta, Canada Recruiting -
North Manchester General Hospital
Manchester, United Kingdom Recruiting -
Wythenshawe Hospital, Southmoor Road
Manchester, United Kingdom Recruiting -
Severance Hospital
Soeul, South Korea Completed
Study contacts
- Principal investigator: Nigel Bundred, MD — Manchester University NHS Foundation Trust
- Study coordinator: Natasha Jones
- Email: Natasha.Jones@mft.nhs.uk
- Phone: 0161 291 4045
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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.