Breast Cancer, Liquid Biopsy, Early DetectionNCT07219277
Clinical Validation of Early Detection Blood Test for Universal Large-scale Breast Cancer Screening
An observational study of Breast Cancer, Liquid Biopsy, Early Detection, run by Syantra Inc. at 4 sites in 3 countries.
Trial 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 illness and death. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Liquid Biopsy, Early Detection
- How many people
- 2,000 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 7 Jan 2026to 14 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Screening and Recall population. Women in the Screening Cohort would be consented just prior to a screening imaging session (within 3 months). Recruitment may also occur after a normal screening imaging session (within 3 months). Women in the Recall population include women called back for follow-up after abnormal imaging or clinical exam. Women at elevated risk of breast cancer development are included. The primary target population for recruitment is women at elevated risk (C or D breast density, family history, and/or genetic elevated risk) called back (recalled) for follow-up imaging or biopsy after an abnormal image with the following distribution: 60% White (non-hispanic), 14% Black, 18% Hispanic, 6% Asian and 2% other.
Who may be able to join
- 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
Who cannot join
- 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
Show all 32Show fewer
- Concomitant or other concurrent anti-cancer therapy
- Blood transfusions within the past 3 months
- Born biologically male
- 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
- 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.
- 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.
- 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
Trial locations and contacts
4 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
4 sites in 3 countries
United States2 sites, 2 recruiting
- Not yet recruiting
Weill Cornell Medicine of Cornell University
New York, New York, 10065
Clinical Trials Administrator, Breast Oncology, 1-646-962-7669, mab4028@med.cornell.edu
- Recruiting
Vincere Cancer Center
Phoenix, Arizona, 85260
Site Study Coordinator, 480-306-5390, kimc@vincerecancer.com
Canada1 site
- Active, not recruiting
Alberta Cancer Research Biobank
Calgary, Alberta, T2N 5G2
United Kingdom1 site, 1 recruiting
- Not yet recruiting
Manchester University NHS Foundation Trust
Manchester
Senior Clinical Trials Coordinator, 0161 291 4411, natasha.jones@mft.nhs.uk
About this study
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
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 illness and death. Identifying the disease in the early stage is important to achieving positive outcomes in response to diagnosis and treatment.
The Syantra blood test has been developed over the past 10 years. This test involves examining blood samples to identify and analyze specific information. This information is run through a software program that then potentially identifies the presence of breast cancer in the blood sample. This test has the potential to increase early stage detection of breast cancer.
Read more
The main goal of this study is to figure out how well the Syantra blood test identifies the presence of breast cancer in women 30-75 years of age. The study will also look at whether things like ethnicity, geography and certain individual characteristics (including breast density and elevated risk of breast cancer development) have an effect on how well the test works.
This study will recruit women who are attending a visit at the site who are aged 30-75 who are undergoing testing for the presence of breast cancer as part of their regular screening or planned follow up imaging and/or biopsy.
Participants who provide consent and meet eligibility criteria will complete a baseline questionnaire and have their blood drawn before any scheduled procedures. Relevant information will be collected from their medical record at the time of joining the study and will be reviewed and updated within 60 days and then again at 12 months following the baseline blood draw. Participants will not have to do anything after the initial visit where they may sign consent, complete the intake questionnaire and have their blood drawn.
Read the 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, and participant characteristics (including breast density and elevated risk of breast cancer development) on test performance.
Investigate tumor characteristics and test development. Study Design: Non-randomized, blinded, non-interventional, longitudinal, multi-center Investigational Device: Syantra blood test Population: Women age 30-75 years testing for the presence of breast cancer as part of regular breast screening or planned follow-up diagnostic imaging and/or biopsy Accrual Goal: 2,000 women Primary Endpoint: Clinical performance of the Syantra blood test in the primary population Procedure: Participants providing consent and meeting eligibility criteria will complete a baseline questionnaire (demographics and medical history) and have their blood drawn prior to surgical procedure or biopsy (if applicable). Participant medical records will be reviewed to collect relevant history, including imaging studies, surgery, and pathology results, along with medical treatments and patient status.
Follow-up: Medical records for participants will be reviewed and updated after completion of diagnostic procedures (within 60 days) and at 12 months post baseline blood draw to complete recording of procedures and status, including interval cancers or other newly diagnosed diseases. Participants with incomplete records or follow-up will be reviewed annually for imaging, pertinent medical issues, and/or outcomes for up to 5 years.
Biospecimen Retention: De-identified blood samples stored for up to 20 years.
- Keywords
- Breast cancer detection, Breast Cancer Screening, Blood Test, Early Detection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Elevated risk population - Asymptomatic | Women at elevated risk undergoing screening for breast cancer who are currently undergoing asymptomatic screening. Presentation of factor(s) indicating elevated risk for breast cancer development including: 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 | |
| Elevated risk population -Recall | Women at elevated risk undergoing screening for breast cancer who are currently undergoing recall screening. Women who have undergone previous MRI and/or screening mammogram or ultrasound indicating follow-up imaging or biopsy recommended and who may have presentation of factor(s) indicating elevated risk for breast cancer development. 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. | |
| 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. | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity (Se) if the test = TP/TP+FN), ratio of true positives to true positives and false negatives
Measured: 3 years
Specificity
Specificity (Sp) of the test = TN/ (TN+FP), ratio of true negatives to the true negatives and false positives
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2025
- Study start7 Jan 2026
- Primary completion14 Jun 2027 (estimated)
- Study completion14 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer, Liquid Biopsy, Early DetectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Syantra Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Calgary
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219277
- Sponsor's protocol ID
- SY-2024-01
- Other IDs
- HT94252410228
- Status last verified
- Mar 2026
- First submitted
- 15 Oct 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is not an interventional study.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07219277
- Acronym / sponsor ID
- SY-2024-01
- Keywords
- Breast cancer detection, Breast Cancer Screening, Blood Test, Early Detection
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Syantra Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Calgary
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 14 Jun 2027 (estimated)
- Study completion
- 14 Jun 2027 (estimated)
- First posted
- 21 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 illness and death. Identifying the disease in the early stage is important to achieving positive outcomes in response to diagnosis and treatment.
The Syantra blood test has been developed over the past 10 years. This test involves examining blood samples to identify and analyze specific information. This information is run through a software program that then potentially identifies the presence of breast cancer in the blood sample. This test has the potential to increase early stage detection of breast cancer.
The main goal of this study is to figure out how well the Syantra blood test identifies the presence of breast cancer in women 30-75 years of age. The study will also look at whether things like ethnicity, geography and certain individual characteristics (including breast density and elevated risk of breast cancer development) have an effect on how well the test works.
This study will recruit women who are attending a visit at the site who are aged 30-75 who are undergoing testing for the presence of breast cancer as part of their regular screening or planned follow up imaging and/or biopsy.
Participants who provide consent and meet eligibility criteria will complete a baseline questionnaire and have their blood drawn before any scheduled procedures. Relevant information will be collected from their medical record at the time of joining the study and will be reviewed and updated within 60 days and then again at 12 months following the baseline blood draw. Participants will not have to do anything after the initial visit where they may sign consent, complete the intake questionnaire and have their blood drawn.
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, and participant characteristics (including breast density and elevated risk of breast cancer development) on test performance.
Investigate tumor characteristics and test development. Study Design: Non-randomized, blinded, non-interventional, longitudinal, multi-center Investigational Device: Syantra blood test Population: Women age 30-75 years testing for the presence of breast cancer as part of regular breast screening or planned follow-up diagnostic imaging and/or biopsy Accrual Goal: 2,000 women Primary Endpoint: Clinical performance of the Syantra blood test in the primary population Procedure: Participants providing consent and meeting eligibility criteria will complete a baseline questionnaire (demographics and medical history) and have their blood drawn prior to surgical procedure or biopsy (if applicable). Participant medical records will be reviewed to collect relevant history, including imaging studies, surgery, and pathology results, along with medical treatments and patient status.
Follow-up: Medical records for participants will be reviewed and updated after completion of diagnostic procedures (within 60 days) and at 12 months post baseline blood draw to complete recording of procedures and status, including interval cancers or other newly diagnosed diseases. Participants with incomplete records or follow-up will be reviewed annually for imaging, pertinent medical issues, and/or outcomes for up to 5 years.
Biospecimen Retention: De-identified blood samples stored for up to 20 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Elevated risk population - Asymptomatic | – | –Women at elevated risk undergoing screening for breast cancer who are currently undergoing asymptomatic screening. Presentation of factor(s) indicating elevated risk for breast cancer development including: 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 |
| Elevated risk population -Recall | – | –Women at elevated risk undergoing screening for breast cancer who are currently undergoing recall screening. Women who have undergone previous MRI and/or screening mammogram or ultrasound indicating follow-up imaging or biopsy recommended and who may have presentation of factor(s) indicating elevated risk for breast cancer development. 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. |
| 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. |
| 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Screening and Recall population. Women in the Screening Cohort would be consented just prior to a screening imaging session (within 3 months). Recruitment may also occur after a normal screening imaging session (within 3 months). Women in the Recall population include women called back for follow-up after abnormal imaging or clinical exam. Women at elevated risk of breast cancer development are included. The primary target population for recruitment is women at elevated risk (C or D breast density, family history, and/or genetic elevated risk) called back (recalled) for follow-up imaging or biopsy after an abnormal image with the following distribution: 60% White (non-hispanic), 14% Black, 18% Hispanic, 6% Asian and 2% other.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (32 listed)
- 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.
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity
Time frame: 3 years
Sensitivity (Se) if the test = TP/TP+FN), ratio of true positives to true positives and false negatives
Specificity
Time frame: 3 years
Specificity (Sp) of the test = TN/ (TN+FP), ratio of true negatives to the true negatives and false positives
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: Undecided. This is not an interventional study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Weill Cornell Medicine of Cornell University
New York, United States
Manchester University NHS Foundation Trust
Manchester, United Kingdom
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, Liquid Biopsy, Early Detection, run by Syantra Inc. at 4 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.