Status:
COMPLETED
Development Of A Blood Test To Improve The Performance Of Breast Cancer Screening
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
GRAIL, Inc.
Conditions:
Breast Cancer
Breast Benign
Eligibility:
FEMALE
18+ years
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 7 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 12 2025
Estimated Enrollment :
628 Patients enrolled
Trial Details
Trial ID
NCT03372902
Start Date
December 7 2017
End Date
March 12 2025
Last Update
March 14 2025
Active Locations (7)
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1
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, United States, 06102
2
Baptist Alliance MCI
Miami, Florida, United States, 33143
3
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
4
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748