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

NCT03372902 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 628

Last updated 2025-03-14

No results posted yet for this study

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

Interventions

DEVICE

Breast MRI

Participants with dense breast tissue will get a mammogram and MRI

DEVICE

Breast Mammogram

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.

OTHER

Blood draw

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.

PROCEDURE

Breast Biopsy

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.

BEHAVIORAL

online participant reported questionnaire

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.

Sponsors & Collaborators

Principal Investigators

  • Katja Pinker-Domenig, MD, PhD · Memorial Sloan Kettering Cancer Center

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-07
Primary Completion
2025-03-12
Completion
2025-03-12

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03372902 on ClinicalTrials.gov