Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:43 AM
Ignite Modification Date:
2025-12-25 @ 3:43 AM
NCT ID:
NCT03372902
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT03372902
Study Brief:
Protocol Section:
NCT03372902