Clinical trial · Observational
Development Of A Blood Test To Improve The Performance Of Breast Cancer Screening
MSK Discovery Study: Use of cfNA To Distinguish Between Benign and Malignant BI-RADS 4 Radiographic Lesions
NCT03372902CI-TRIAL-00087208completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Benign | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw | Other | — | UNRESOLVED |
| Breast Biopsy | Procedure | — | UNRESOLVED |
| Breast Mammogram | Device | — | UNRESOLVED |
| Breast MRI | Device | — | UNRESOLVED |
| online participant reported questionnaire | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- normal mammograms (BI-RADS 1 or 2)
- interventionNames
- Device: Breast MRI
- Device: Breast Mammogram
- Other: Blood draw
- Behavioral: online participant reported questionnaire
- label
- suspicious lesion group (BI-RADS 4)
- interventionNames
- Device: Breast MRI
- Device: Breast Mammogram
- Other: Blood draw
- Procedure: Breast Biopsy
- Behavioral: online participant reported questionnaire
Primary outcomes (1)
- measure
- number of participants with malignant biopsy
- timeFrame
- 2 years
- description
- result of the biopsy of the BIRADS 4 breast
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.