No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Study type
Observational
Participants needed
490 (estimated)
Sponsor
University of Southern California · Other
Who this trial is looking for
This trial is looking for women to help understand if a special blood test can accurately indicate breast cancer diagnosis. Participants will provide a blood sample and may need to have had certain types of mammograms or biopsies.
Are You a Good Fit for This Trial?
You may be able to join if
I am a woman.
I am at least 18 years old.
I will have a mammogram within 6 months of my blood draw.
I have abnormal mammogram results or an abnormal MRI that needs further testing.
I have a new biopsy-proven diagnosis of breast cancer within the last 60 days.
I have a history of localized breast cancer that is in complete remission.
You may not be able to join if
I cannot give informed consent.
I have received a blood transfusion in the last 14 days.
I have had a heart attack, stroke, or pulmonary embolism in the last 3 months.
I had an excisional breast biopsy in the last 30 days.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
This study evaluates whether a special type of blood analysis, called liquid biopsy (LBx), correlates with mammography results and/or diagnosis of breast cancer.
Trial Locations
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City
State
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Status
Eligibility Criteria
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 pers…
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
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