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

Completed

• Conditions: Breast Cancer; Breast Benign
• Interventions: Device: Breast MRI; Device: Breast Mammogram; Other: Blood draw; Procedure: Breast Biopsy; Behavioral: online participant reported questionnaire

• Registration Number: NCT03372902
• Lead Sponsor: Memorial Sloan Kettering Cancer 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-07
• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-11
• Study First Posted: 2017-12-14
• Status Verified: 2025-03
• Primary Completion: 2025-03-12
• Study Completion: 2025-03-12
• Last Update Submitted: 2025-03-13
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 628

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
normal mammograms (BI-RADS 1 or 2)	Breast MRI	-
normal mammograms (BI-RADS 1 or 2)	Breast Mammogram	-
suspicious lesion group (BI-RADS 4)	online participant reported questionnaire	-
normal mammograms (BI-RADS 1 or 2)	Blood draw	-
suspicious lesion group (BI-RADS 4)	Blood draw	-
normal mammograms (BI-RADS 1 or 2)	online participant reported questionnaire	-
suspicious lesion group (BI-RADS 4)	Breast MRI	-
suspicious lesion group (BI-RADS 4)	Breast Mammogram	-
suspicious lesion group (BI-RADS 4)	Breast Biopsy	-

Primary Outcome Measures

Name	Time	Method
number of participants with malignant biopsy	2 years	result of the biopsy of the BIRADS 4 breast

Trial Locations

Locations (7)

Hartford Healthcare Cancer Institute @ Hartford Hospital; 🇺🇸 Hartford, Connecticut, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Baptist Alliance MCI; 🇺🇸 Miami, Florida, United States

Memorial Sloan Kettering Commack; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Monmouth; 🇺🇸 Middletown, New Jersey, United States

Memorial Sloan Kettering Westchester; 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering at Basking Ridge; 🇺🇸 Basking Ridge, New Jersey, United States