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OpenTrials
Completed

NCT Number: NCT03372902

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

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.

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Key information

Conditions

Breast Cancer Breast Benign Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hartford Healthcare Cancer Institute @ Hartford Hospital, Hartford, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Breast MRI

Device

Participants with dense breast tissue will get a mammogram and MRI

Breast Mammogram

Device

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.

Blood Draw

Other

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.

breast biopsy

Procedure

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.

online participant reported questionnaire

Behavioral

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.

Primary outcomes

  1. number of participants with malignant biopsy

    Time frame: 2 years

    result of the biopsy of the BIRADS 4 breast

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • GRAIL, Inc.

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2025
Study completion
2025
First posted
Dec 14, 2017
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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