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

CompletedOBSERVATIONAL
Enrollment

628

Participants

Timeline

Start Date

December 7, 2017

Primary Completion Date

March 12, 2025

Study Completion Date

March 12, 2025

Conditions
Breast CancerBreast Benign
Interventions
DEVICE

Breast MRI

Participants with dense breast tissue will get a mammogram and MRI

DEVICE

Breast 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.

OTHER

Blood 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.

PROCEDURE

Breast 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.

BEHAVIORAL

online 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.

Trial Locations (7)

10065

Memorial Sloan Kettering Cancer Center, New York

10604

Memorial Sloan Kettering Westchester, Harrison

11725

Memorial Sloan Kettering Commack, Commack

33143

Baptist Alliance MCI, Miami

06102

Hartford Healthcare Cancer Institute @ Hartford Hospital, Hartford

07920

Memorial Sloan Kettering at Basking Ridge, Basking Ridge

07748

Memorial Sloan Kettering Monmouth, Middletown

All Listed Sponsors
collaborator

GRAIL, Inc.

INDUSTRY

lead

Memorial Sloan Kettering Cancer Center

OTHER

NCT03372902 - Development Of A Blood Test To Improve The Performance Of Breast Cancer Screening | Biotech Hunter | Biotech Hunter