Actively Recruiting

Age: 18Years +
FEMALE
NCT06336928

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

Led by University of Southern California · Updated on 2026-03-12

490

Participants Needed

4

Research Sites

313 weeks

Total Duration

On this page

Sponsors

U

University of Southern California

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women aged 18 years or older
  • Screening Mammography Cohort: Patients referred for screening mammography with mammogram within 6 months before or after blood draw; no personal history of breast cancer but history of breast biopsy or prior abnormal mammography allowed
  • Abnormal Screening Cohort: Patients with abnormal mammography (BIRADS 3, 4, 5) or abnormal MRI needing further testing; no history of breast cancer; blood draw between abnormal imaging and start of definitive treatment; no prior surgery or excisional biopsy for abnormal findings
  • New Breast Cancer Cohort: Patients with new biopsy-proven breast cancer diagnosis within 60 days of blood draw; no prior cancer-directed therapy started
  • Remission Breast Cancer Cohort: Patients with treated localized breast cancer (stage 1-3) in remission; completed surgery, chemotherapy, and/or radiation before enrollment; blood draw at least 90 days after treatment; patients on adjuvant hormonal therapy eligible if CDK4/6 inhibitor therapy completed
Not Eligible

You will not qualify if you...

  • Unable to give informed consent
  • Received blood transfusion within 14 days before study blood draw
  • Had heart attack, stroke, or pulmonary embolism within 3 months before study blood draw
  • Had excisional breast biopsy within 30 days before study blood draw; needle biopsy is allowed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 4 locations

1

Keck Medicine of USC Koreatown

Los Angeles, California, United States, 90020

Actively Recruiting

2

Los Angeles General Medical Center

Los Angeles, California, United States, 90033

Actively Recruiting

3

USC / Norris Comprehensive Cancer Center

Los Angeles, California, United States, 90033

Actively Recruiting

4

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, United States, 92663

Actively Recruiting

Loading map...

Research Team

K

Kimberly Arieli, RN

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here