Recruiting

Liquid Biopsy

Sponsor:

University of Southern California

Code:

NCT06336928

Conditions

Breast Carcinoma

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Interventional Study

Study Details

Brief summary:

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

Breast Carcinoma

Study ID

NCT06336928

Start date

Jun 7, 2024

Status verified date

Mar, 2026

Completion date

Jun 7, 2030

Anticipated

Primary completion date

Jun 7, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

490 participants

Anticipated

Interventions and Outcome Measures

Arms

Observational

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

Interventions

Non-Interventional Study

Non-interventional study

Primary outcome measure

  • Assess the sensitivity and specificity of LBx as a screening method for breast cancer [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Kimberly Arieli, RN

323-865-0451Kimberly.Arieli@med.usc.edu

Locations

Keck Medicine of USC Koreatown

Recruiting

Los Angeles, California, United States, 90020

Contacts

Kimberly Arieli

323-865-0451Kimberly.Arieli@med.usc.edu

Principal Investigator:

Anastasia Martynova, MD

Los Angeles General Medical Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Kimberly Arieli, RN

323-865-0451Kimberly.Arieli@med.usc.edu

Principal Investigator:

Anastasia Martynova, MD

USC / Norris Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90033

Contacts

Kimberly Arieli, RN

323-865-0451Kimberly.Arieli@med.usc.edu

Principal Investigator:

Anastasia Martynova, MD

USC Norris Oncology/Hematology-Newport Beach

Recruiting

Newport Beach, California, United States, 92663

Contacts

Kristy Massopust

949-474-5733Massopust_K@med.usc.edu

Principal Investigator:

Anastasia Martynova, MD

More Information

Sponsor

University of Southern California

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

  • Liquid biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Southern California on 2026-03-12.