Clinical trial NCT03372902: Development Of A Blood Test To Improve The Performance Of Breast Cancer Screening
Official title: MSK Discovery Study: Use of cfNA To Distinguish Between Benign and Malignant BI-RADS 4 Radiographic Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Breast Benign
Keywords: Breast imaging
17-598
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: GRAIL, Inc.
First posted: 2017-12-14
Enrollment: 628
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Females with one or more BI-RADS 4 radiographic lesion who are undergoing ultrasound, stereotactic or MRI-guided breast biopsy at a participating study center.

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.


Eligibility criteria: 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

Primary outcomes:
measure: number of participants with malignant biopsy
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Healthcare Cancer Institute @ Hartford Hospital
state: Connecticut
city: Miami
country: United States
facility: Baptist Alliance MCI
state: Florida
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering at Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Katja Pinker-Domenig, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: