Status:
NOT_YET_RECRUITING
Clinical Validation of Early Detection Blood Test for Universal Large-scale Breast Cancer Screening
Lead Sponsor:
Syantra Inc.
Collaborating Sponsors:
University of Calgary
Conditions:
Breast Cancer, Liquid Biopsy, Early Detection
Eligibility:
FEMALE
30-75 years
Brief Summary
Breast cancer is the most common cancer that spreads beyond the initial layer of tissue it developed in, and grows into surrounding healthy tissue in women worldwide. It is associated with significant...
Detailed Description
Primary Objective: Determine clinical performance metrics of the Syantra blood test in a population of women 30-75 years of age. Secondary Objectives: Investigate the role of ethnicity, geography, an...
Eligibility Criteria
Inclusion
- 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
- 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
- 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
Exclusion
Key Trial Info
Start Date :
October 27 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 14 2027
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT07219277
Start Date
October 27 2025
End Date
June 14 2027
Last Update
October 21 2025
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Vincere Cancer Center
Phoenix, Arizona, United States, 85260
2
Weill Cornell Medicine of Cornell University
New York, New York, United States, 10065
3
Alberta Cancer Research Biobank
Calgary, Alberta, Canada, T2N 5G2
4
Manchester University NHS Foundation Trust
Manchester, United Kingdom