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

Sponsor: Syantra Inc.

NCT ID: NCT07219277

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Not specified by the sponsor
How long the study runs
Study runs about 17 months (dates as stated)
About the drug or intervention
Not specified by the sponsor
Patient visit burden
Not specified by the sponsor

In plain English

This study is testing a blood test that may help find breast cancer early. The researchers want to see if the blood test can correctly spot breast cancer in women having routine breast screening or follow-up checks. It is run by Syantra Inc.

Who can take part

  • Women aged 30 to 75 who are having breast screening (mammogram, ultrasound, or magnetic resonance imaging (MRI)) or follow-up imaging or a biopsy
  • For the higher-risk groups: having factors that raise breast cancer risk, such as a gene change (mutation) that increases risk, very dense breast tissue, a family history, or a high score on a risk assessment tool
  • Being willing and able to give written consent and provide a blood sample
  • For women without symptoms: no physical breast symptoms or concerns

Who may not be able to

  • Having current breast symptoms or concerns (for the screening groups), or a current or suspected cancer diagnosis
  • Breast surgery or a breast biopsy in the last 12 months
  • Any past cancer (except non-melanoma skin cancer), including breast cancer or DCIS for some groups
  • Cancer treatment at the same time (for the higher-risk screening group)
  • A blood transfusion in the past 3 months
  • Being born biologically male

What taking part involves

  • • Providing a whole blood sample
  • • Your screening or follow-up imaging results (mammogram, ultrasound, MRI, or biopsy) will be compared with the blood test results

Time commitment: Not stated — ask the trial team about the number of visits, how long the study lasts, and exactly what taking part involves, apart from giving a blood sample.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Observing health over time
Ages
30 Years to 75 Years
Who
Female
Number of participants
2,000
Started
2026-01-07
Last checked
2026-03

Plain English Summary

What is this study?

  • • Testing a new treatment for breast cancer, liquid biopsy, early detection
  • • Clinical study - 2,000 participants
  • • 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

Who can take part?

  • • Ages 30 Years to 75 Years
  • • Diagnosed with breast cancer, liquid biopsy, early detection
  • • Female only

Where?

  • • Manchester - Manchester University NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Breast Cancer, Liquid Biopsy, Early Detection

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 30 Years - 75 Years
  • Who can join: Female only

What the study is looking for

  • ✓Elevated risk population sub-group: Women at elevated risk undergoing routine screening for breast cancer.
  • ✓A. not causing symptoms 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
See the full 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 Is This Study? (1 UK site)

Manchester University NHS Foundation Trust

Manchester, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Senior Clinical Trials Coordinator0161 291 4411natasha.jones@mft.nhs.uk
Data sourced from ClinicalTrials.gov · Last verified: 2026-03