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Use Of A Blood Test To Improve The Performance Of Imaging For Breast Cancer Screening

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ClinicalTrials.gov Identifier: NCT03372902
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : January 18, 2018
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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 patients who have had an area of concern found on breast imaging, as well as from patients who are scheduled to have a routine breast cancer screening mammogram.

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

Study Design

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

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
normal mammograms (BI-RADS 1 or 2) Device: Breast MRI
participants with dense breasts will get 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 six 10ml Discovery Blood Collection tubes 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 patient reported questionnaire
All patients will be asked to complete a questionnaire that covers the topics of breast health, general health and lifestyle, as well as genetic testing, personal, and family history of cancer. The patient questionnaire will be administered either in clinic on a GRAIL-provided laptop computer or via a unique online access code from the patient's home.
suspicious lesion group (BI-RADS 4) Device: Breast MRI
participants with dense breasts will get 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 six 10ml Discovery Blood Collection tubes 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 patients diagnosed with cancer during the follow-up period will also undergo molecular profiling.
Behavioral: online patient reported questionnaire
All patients will be asked to complete a questionnaire that covers the topics of breast health, general health and lifestyle, as well as genetic testing, personal, and family history of cancer. The patient questionnaire will be administered either in clinic on a GRAIL-provided laptop computer or via a unique online access code from the patient's home.


Outcome Measures

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


Biospecimen Retention:   Samples With DNA
blood, tissue

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

Inclusion Criteria:

Cohort I - BI-RADS 4 Cohort

  • Females with one or more BI-RADS 4 radiographic lesion 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. Patients 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
  • Patients with a current active malignancy other than non-melanoma skin cancers. Patients 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)
  • Patients with a current active malignancy other than non-melanoma skin cancers. Patients 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
Contacts and Locations

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


Contacts
Contact: Elizabeth Morris, MD 646-888-4510 morrise@mskcc.org
Contact: Jorge Reis-Filho, MD, PhD 212-639-8054

Locations
United States, New Jersey
Memorial Sloan-Kettering at Basking Ridge Recruiting
Basking Ridge, New Jersey, United States, 07920
Contact: Elizabeth Morris, MD    646-888-4510      
Memoral Sloan Kettering Monmouth Recruiting
Middletown, New Jersey, United States, 07748
Contact: Elizabeth Morris, MD    646-888-4510      
United States, New York
Memorial Sloan Kettering Commack Recruiting
Commack, New York, United States, 11725
Contact: Elizabeth Morris, MD    646-888-4510      
Memoral Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Elizabeth Morris, MD    646-888-4510      
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Elizabeth Morris, MD    646-888-4510      
Principal Investigator: Elizabeth Morris, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
GRAIL, Inc.
Investigators
Principal Investigator: Elizabeth Morris, MD Memorial Sloan Kettering Cancer Center
More Information

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: January 18, 2018
Last Verified: January 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