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

NCT03372902 | Completed

• 1 other identifier: 17-598
• Study Type: observational
• Target: 628
• Locations: 1 country
• Sites: 7

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.

Conditions

Breast Cancer; Breast Benign

Keywords

Breast imaging; 17-598

Outcome Measures

Primary Outcomes (1)

• number of participants with malignant biopsy

  result of the biopsy of the BIRADS 4 breast

  2 years

Study Arms (2)

normal mammograms (BI-RADS 1 or 2)

Device: Breast MRI; Device: Breast Mammogram; Other: Blood draw; Behavioral: online participant reported questionnaire

suspicious lesion group (BI-RADS 4)

Device: Breast MRI; Device: Breast Mammogram; Other: Blood draw; Procedure: Breast Biopsy; Behavioral: online participant reported questionnaire

Interventions

Breast MRI DEVICE

Participants with dense breast tissue will get a mammogram and MRI

normal mammograms (BI-RADS 1 or 2); suspicious lesion group (BI-RADS 4)

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.

normal mammograms (BI-RADS 1 or 2); suspicious lesion group (BI-RADS 4)

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.

normal mammograms (BI-RADS 1 or 2); suspicious lesion group (BI-RADS 4)

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.

suspicious lesion group (BI-RADS 4)

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.

normal mammograms (BI-RADS 1 or 2); suspicious lesion group (BI-RADS 4)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Females with one or more BI-RADS 4 radiographic lesion who are undergoing ultrasound, stereotactic or MRI-guided breast biopsy at a participating study center.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• GRAIL, Inc.: collaborator

Study Sites (7)

Hartford Healthcare Cancer Institute @ Hartford Hospital

Hartford, Connecticut, 06102, United States

Location

Baptist Alliance MCI

Miami, Florida, 33143, United States

Location

Memorial Sloan Kettering at Basking Ridge

Basking Ridge, New Jersey, 07920, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Commack

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

blood, tissue

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Katja Pinker-Domenig, MD, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 14, 2017
• Study Start: December 7, 2017
• Primary Completion: March 12, 2025
• Study Completion: March 12, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

US (7)