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

Breast Cancer Clinical Trial

Official title:

MSK Discovery Study: Use of cfNA To Distinguish Between Benign and Malignant BI-RADS 4 Radiographic Lesions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03372902
• Other study ID #: 17-598
• Status: Active, not recruiting
• Start date: December 7, 2017
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 725
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Benign
• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Breast MRI
Participants with dense breast tissue will get a mammogram and MRI
• 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.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering at Basking Ridge	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Hartford Healthcare Cancer Institute @ Hartford Hospital	Hartford	Connecticut
United States	Baptist Alliance MCI	Miami	Florida
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	GRAIL, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants with malignant biopsy	result of the biopsy of the BIRADS 4 breast	2 years

External Links

•   Memorial Sloan Kettering Cancer Center