Breast Cancer, Breast Benign
Conditions
Keywords
Breast imaging, 17-598
Brief summary
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.
Interventions
DEVICEBreast MRI
Participants with dense breast tissue will get a mammogram and MRI
DEVICEBreast Mammogram
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.
OTHERBlood draw
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.
PROCEDUREBreast Biopsy
Tissue specimens from the biopsy of the BI-RADS 4 mammographic lesion and (among women undergoing surgical excision) the surgical specimen(s) will be subjected to genomic profiling at GRAIL, Inc. or MSKCC. The tumor specimens from the participants diagnosed with cancer during the follow-up period will also undergo molecular profiling.
BEHAVIORALonline participant reported questionnaire
Participants will be asked to complete a questionnaire that covers the topics of breast health, general health and lifestyle, genetic testing, personal, and family history of cancer.
Sponsors
GRAIL, Inc.
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of participants with malignant biopsy | 2 years | result of the biopsy of the BIRADS 4 breast |
Countries
United States
Outcome results
None listed