Development Of A Blood Test To Improve The Performance Of Breast Cancer Screening

Memorial Sloan Kettering Cancer Center628 enrolled

Overview

The purpose of this study is to collect blood and tissue to help develop tests that might be able to detect cancer earlier. The investigator will be collecting these samples and reviewing test results from participants who have had an area of concern found on breast imaging, as well as from participants who are scheduled to have a routine breast cancer screening mammogram.

Study Type

OBSERVATIONAL

Enrollment

628

Conditions

Breast Cancer Breast Benign

Interventions

Breast MRIDEVICE

Participants with dense breast tissue will get a mammogram and MRI

Breast MammogramDEVICE

State-of-the-art full-field digital mammography (FFDM) and or digital breast tomosynthesis (DBT) comprising both raw and post-processed images as well as ultrasound and MRI images from the initial screening study will be collected and sent to the MSKCC Breast Radiology Department.

Blood drawOTHER

Participants will donate approximately 60ml of peripheral blood. Mononuclear cells from peripheral blood will be used to extract germline DNA. Germline genomic testing will be employed as a matched control for tumor sequencing and for germline breast cancer susceptibility testing.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Females with one or more BI-RADS 4 radiographic lesions who are undergoing ultrasound, stereotactic or MRI-guided breast biopsy at MSKCC or at an MSK Alliance Member Site. If multiple imaging modalities were employed (mammogram, ultrasound, MRI) and no integrated score is provided, then the highest BI-RADS score will be used. * Age ≥ 18 years at the time of breast biopsy * Willing to provide blood samples for research purposes before biopsy. * Able to provide written informed consent Exclusion Criteria: * Women with a BI-RADS 4 lesion who had the lesion previously biopsied * Females with a current active malignancy other than non-melanoma skin cancers. Females are considered not to have a "current active" malignancy if they have completed therapy and have no evidence of systemic disease for at least three years from the initial diagnosis * Currently pregnant women * History of bilateral mastectomy. * Participant has or is currently participating in another GRAIL-sponsored protocol

Locations (7)

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, United States

Baptist Alliance MCI

Miami, Florida, United States

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, United States

Outcomes

Primary Outcomes

number of participants with malignant biopsy

result of the biopsy of the BIRADS 4 breast

Time frame: 2 years

Data from ClinicalTrials.gov

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