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

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ClinicalTrials.gov Identifier: NCT03372902
Recruitment Status : Enrolling by invitation
First Posted : December 14, 2017
Last Update Posted : May 18, 2018
Sponsor:
Collaborator:
GRAIL, Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment
Breast Cancer Breast Benign Device: Breast MRI Device: Breast Mammogram Other: Blood draw Procedure: Breast Biopsy Behavioral: online participant reported questionnaire

Study Type : Observational
Estimated Enrollment : 2347 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: MSK Discovery Study: Use of cfNA To Distinguish Between Benign and Malignant BI-RADS 4 Radiographic Lesions
Actual Study Start Date : December 7, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
normal mammograms (BI-RADS 1 or 2) 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.

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.

suspicious lesion group (BI-RADS 4) 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.




Primary Outcome Measures :
  1. number of participants with malignant biopsy [ Time Frame: 2 years ]
    result of the biopsy of the BIRADS 4 breast


Biospecimen Retention:   Samples With DNA
blood, tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast cancer
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

Cohort I - BI-RADS 4 Cohort

  • 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

Cohort II - Reference Cohort A. Unselected BI-RADS 1/2 Cohort

  • Females undergoing screening mammogram at MSKCC
  • Age ≥ 18 years at the time of mammogram.
  • Willing to provide blood samples for research purposes at time of mammogram
  • Able to provide written informed consent. B. Females with Dense Breasts and BI-RADS 1/2 Mammogram and MRI
  • Females undergoing screening MRI at MSKCC
  • Dense breasts (C or D) on screening mammogram performed within 3 months prior to screening MRI
  • Age ≥ 18 years at the time of MRI
  • Willing to provide blood samples for research purposes at time of MRI.
  • Able to provide written informed consent

Exclusion Criteria:

Cohort I - BI-RADS 4 Cohort

  • 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

Cohort II - Reference Cohorts (Both A and B)

  • 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.
  • Pregnant women.
  • History of bilateral mastectomy
  • Participant on another GRAIL-sponsored protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372902


Locations
United States, Connecticut
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, United States, 06102
United States, Florida
Baptist Alliance MCI
Miami, Florida, United States, 33143
United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge
Basking Ridge, New Jersey, United States, 07920
Memoral Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
United States, New York
Memorial Sloan Kettering Commack
Commack, New York, United States, 11725
Memoral Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
GRAIL, Inc.
Investigators
Principal Investigator: Elizabeth Morris, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03372902     History of Changes
Other Study ID Numbers: 17-598
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Breast imaging
17-598

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases