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

This study evaluates whether a special type of blood analysis, called liquid biopsy (LBx), correlates with mammography results and/or diagnosis of breast cancer.

Study Overview

• Status: Recruiting
• Conditions: Breast Carcinoma
• Intervention / Treatment: Other: Non-Interventional Study

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the sensitivity of LBx for the presence of breast cancer in patient cohorts II. Determine the specificity of LBx for the presence of breast cancer in all patient cohorts.

OUTLINE: This is an observational study.

Patients undergo blood sample collection and have their medical records reviewed on study.

• Study Type: Observational
• Enrollment (Estimated): 490

Contacts and Locations

• Study Contact: Name: Kimberly Arieli, RN; Phone Number: 323-865-0451; Email: Kimberly.Arieli@med.usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • Recruiting
      • USC / Norris Comprehensive Cancer Center
      • Contact: Kimberly Arieli, RN; Phone Number: 323-865-0451; Email: Kimberly.Arieli@med.usc.edu
      • Principal Investigator: Anastasia Martynova, MD
    • Los Angeles, California, United States, 90020
      • Recruiting
      • Keck Medicine of USC Koreatown
      • Principal Investigator: Anastasia Martynova, MD
      • Contact: Kimberly Arieli; Phone Number: 323-865-0451; Email: Kimberly.Arieli@med.usc.edu
    • Los Angeles, California, United States, 90033
      • Recruiting
      • Los Angeles General Medical Center
      • Contact: Kimberly Arieli, RN; Phone Number: 323-865-0451; Email: Kimberly.Arieli@med.usc.edu
      • Principal Investigator: Anastasia Martynova, MD
    • Newport Beach, California, United States, 92663
      • Recruiting
      • USC Norris Oncology/Hematology-Newport Beach
      • Contact: Kristy Massopust; Phone Number: 949-474-5733; Email: Massopust_K@med.usc.edu
      • Principal Investigator: Anastasia Martynova, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Women referred for mammography, women newly diagnosed with breast cancer and completed no treatment, or women with history of localized breast cancer.

Description

Inclusion Criteria:

• * 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 Criteria:

• * 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Observational; Patients undergo blood sample collection and have their medical records reviewed on study.	Other: Non-Interventional Study; Non-interventional study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess the sensitivity and specificity of LBx as a screening method for breast cancer	LBx results using peripheral blood samples will be compared to a pathological diagnosis of breast cancer within 1 year of the liquid biopsy test.	Up to 1 year

Collaborators and Investigators

• Sponsor: University of Southern California
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Anastasia Martynova, MD, University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2024
• Primary Completion (Estimated): June 7, 2029
• Study Completion (Estimated): June 7, 2030

Study Registration Dates

• First Submitted: March 21, 2024
• First Submitted That Met QC Criteria: March 21, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 12, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Liquid biopsy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 1B-23-6 (Other Identifier: USC / Norris Comprehensive Cancer Center); P30CA014089 (U.S. NIH Grant/Contract); NCI-2024-01332 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No