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

NCT06336928 | Recruiting DMC

• 3 other identifiers: 1B-23-6NCI-2024-01332P30CA014089
• Study Type: observational
• Target: 490
• Locations: 1 country
• Sites: 4

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

Keywords

Liquid biopsy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Observational

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

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \* 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).

You may not qualify if:

• \* 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

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Keck Medicine of USC Koreatown

Los Angeles, California, 90020, United States

RECRUITING

Los Angeles General Medical Center

Los Angeles, California, 90033, United States

RECRUITING

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

RECRUITING

USC Norris Oncology/Hematology-Newport Beach

Newport Beach, California, 92663, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Anastasia Martynova, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kimberly Arieli, RN

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 29, 2024
• Study Start: June 7, 2024
• Primary Completion (Estimated): June 7, 2029
• Study Completion (Estimated): June 7, 2030
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

US (4)