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

March 21, 2024 updated by: University of Southern California
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

Not yet recruiting

Conditions

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Anastasia Martynova, MD
      • Los Angeles, California, United States, 90020
        • Keck Medicine of USC Koreatown
        • Contact:
        • Principal Investigator:
          • Anastasia Martynova, MD
      • Los Angeles, California, United States, 90033
        • Los Angeles General Medical Center
        • Contact:
        • Principal Investigator:
          • Anastasia Martynova, MD
      • Newport Beach, California, United States, 92663
        • USC Norris Oncology/Hematology-Newport Beach
        • Contact:
        • Principal Investigator:
          • Anastasia Martynova, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: Up 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.
Up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Anastasia Martynova, MD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

April 1, 2029

Study Completion (Estimated)

April 1, 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 29, 2024

Last Update Submitted That Met QC Criteria

March 21, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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