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

Memorial Sloan Kettering Cancer Center (MSK)

Status

Completed

Conditions

Breast Benign

Breast Cancer

Treatments

Behavioral: online participant reported questionnaire

Device: Breast MRI

Other: Blood draw

Device: Breast Mammogram

Procedure: Breast Biopsy

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT03372902

17-598

Details and patient eligibility

About

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.

Enrollment

628 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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