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Observational Study of Liquid Biopsy for Breast Cancer Diagnosis

This study is looking at a new way to screen for breast cancer using a blood test called a liquid biopsy (LBx). Researchers want to see if this blood test can accurately detect breast cancer by comparing its results to mammograms. The study aims to find out how good the liquid biopsy is at identifying breast cancer when it's present (sensitivity) and how good it is at showing no cancer when it's not there (specificity). You can join if you are a woman aged 18 or older who is having a screening mammogram within six months of a blood draw, and you don't have a personal history of breast cancer or previous abnormal mammogram findings. The study is currently unclear about its recruitment status and plans to enroll 490 participants.

Study design
This is an observational study, meaning participants will be monitored without receiving a specific treatment. It aims to enroll 490 women.
What's involved
Participants will provide a blood sample and have their medical records reviewed. The study will last up to one year.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to one year to assess the sensitivity and specificity of the liquid biopsy.

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NCT06336928

A Validation Study to Determine Concordance of Liquid Biopsy and Breast Cancer Diagnosis

Recruiting
Not specifiedAges 18+Observational
University of Southern California
~490 participants
Updated 2026-03-12 on ClinicalTrials.gov
What's tested:Non-Interventional Study

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess the sensitivity and specificity of LBx as a screening method for breast cancer
Measured over Up to 1 year

Conditions

Breast Carcinoma

Explore related trials

Breast Carcinoma

Where it's being run

4 sites across 1 states
California4

Study leadership

  • Anastasia Martynova, MD · PRINCIPAL_INVESTIGATOR · University of Southern California

Who to contact

Kimberly Arieli, RN
[email protected]
323-865-0451
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

\* Women
Age ≥ 18 years.
Screening Mammography Cohort: Patients who were referred for screening mammography and had mammography performed within 6 months prior to blood draw or will be undergoing mammography within 6 months after blood draw. Patient must not have personal history of breast cancer, history of breast biopsy or prior abnormal mammography findings are allowed. OR
Abnormal Screening Cohort: Patient who has had mammography that revealed abnormal results (BIRADS 3, 4, 5) or abnormal MRI results requiring further testing (additional imaging modality or biopsy). Patients must not have a history of breast cancer, history of breast biopsy, or prior abnormal mammography findings are allowed. The blood draw must occur in the time between the abnormal mammography and start of definitive treatment (surgery or neoadjuvant chemotherapy). Patients who have already undergone surgery/excisional biopsy due to abnormal mammography findings are not eligible. OR
New Beast Cancer Cohort: Patients with new biopsy proven diagnosis of breast cancer (invasive breast cancer or DCIS) within 60 days of blood draw who has not started any cancer directed therapy, including surgery, radiation, hormonal therapy or chemotherapy. Any breast cancer type patients at any stage are eligible. OR
Remission Breast Cancer Cohort: Patients with personal history of localized breast cancer (stage 1, 2, 3) that has been previously treated with cancer directed therapy, such as surgery, chemotherapy, radiation and/or hormonal therapy who has been in completed remission. Patients must complete their surgery, adjuvant chemotherapy and/or radiation therapy prior to enrollment. The blood draw must occur at least 90 days after completion of the specified treatment modalities. Patients on adjuvant hormonal therapy are eligible to enroll (those who are treated with adjuvant hormonal therapy in combination with CDK4/6 inhibitor must complete CDK4/6 inhibitor therapy prior to enrollment).

Exclusion

\* Patients unable to give informed consent
Patients who have received blood transfusion with 14 days prior to study blood draw
Patients who had a heart attack, stroke, or pulmonary embolism within 3 months to study blood draw
Excisional breast biopsy in the prior 30 days. Needle biopsy of the breast is permitted

What this trial measures

  • Assess the sensitivity and specificity of LBx as a screening method for breast cancerUp to 1 year

    LBx results using peripheral blood samples will be compared to a pathological diagnosis of breast cancer within 1 year of the liquid biopsy test.