Development Of A Blood Test To Improve The Performance Of Breast Cancer Screening
NCT ID: NCT03372902
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
628 participants
OBSERVATIONAL
2017-12-07
2025-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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normal mammograms (BI-RADS 1 or 2)
Breast MRI
Participants with dense breast tissue will get a mammogram and MRI
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.
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.
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.
suspicious lesion group (BI-RADS 4)
Breast MRI
Participants with dense breast tissue will get a mammogram and MRI
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.
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.
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.
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.
Interventions
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Breast MRI
Participants with dense breast tissue will get a mammogram and MRI
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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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GRAIL, Inc.
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Katja Pinker-Domenig, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, United States
Baptist Alliance MCI
Miami, Florida, United States
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Commack
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Countries
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Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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17-598
Identifier Type: -
Identifier Source: org_study_id
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