Breast CancerNCT03372902
Development Of A Blood Test To Improve The Performance Of Breast Cancer Screening
An observational study of Breast Cancer and Breast Benign, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Benign
- What is being tested?
- Breast MRI, Breast Mammogram and Blood draw
- Type of treatment
- Medical device, Surgery or procedure, Lifestyle or therapy programme
- How many people
- 628 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 Dec 2017to 12 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Commack
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Hartford Healthcare Cancer Institute @ Hartford Hospital
Hartford, Connecticut, 06102
Baptist Alliance MCI
Miami, Florida, 33143
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: MSK Discovery Study: Use of cfNA To Distinguish Between Benign and Malignant BI-RADS 4 Radiographic Lesions
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
- Being tested
- Breast MRI, Breast Mammogram, Blood draw, Breast Biopsy, online participant reported questionnaire
- Keywords
- Breast imaging, 17-598
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast MRIDevice
Participants with dense breast tissue will get a mammogram and MRI
Breast MammogramDevice
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 drawOther
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 BiopsyProcedure or surgery
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 questionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| normal mammograms (BI-RADS 1 or 2) | Not described Receives: Device: Breast MRI; Device: Breast Mammogram; Other: Blood draw; Behavioral: online participant reported questionnaire | |
| suspicious lesion group (BI-RADS 4) | Not described Receives: Device: Breast MRI; Device: Breast Mammogram; Other: Blood draw; Procedure: Breast Biopsy; Behavioral: online participant reported questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with malignant biopsy
result of the biopsy of the BIRADS 4 breast
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start7 Dec 2017
- Primary completion12 Mar 2025
- Study completion12 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 628 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- GRAIL, Inc.
- Responsible party
- Sponsor
- Investigators
- Katja Pinker-Domenig, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03372902
- Sponsor's protocol ID
- 17-598
- Status last verified
- Mar 2025
- First submitted
- 11 Dec 2017
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MSK Discovery Study: Use of cfNA To Distinguish Between Benign and Malignant BI-RADS 4 Radiographic Lesions
- ClinicalTrials.gov ID
- NCT03372902
- Acronym / sponsor ID
- 17-598
- Conditions
- Breast Cancer, Breast Benign
- Keywords
- Breast imaging, 17-598
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 628 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- GRAIL, Inc.
- Study start
- 7 Dec 2017 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- 12 Mar 2025 (actual)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breast MRIParticipants with dense breast tissue will get a mammogram and MRI | Device | normal mammograms (BI-RADS 1 or 2), suspicious lesion group (BI-RADS 4) |
| Breast MammogramState-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. | Device | normal mammograms (BI-RADS 1 or 2), suspicious lesion group (BI-RADS 4) |
| Blood drawParticipants 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. | Other | normal mammograms (BI-RADS 1 or 2), suspicious lesion group (BI-RADS 4) |
| Breast BiopsyTissue 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. | Procedure or surgery | suspicious lesion group (BI-RADS 4) |
| online participant reported questionnaireParticipants 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. | Behavioural | normal mammograms (BI-RADS 1 or 2), suspicious lesion group (BI-RADS 4) |
Primary outcome
number of participants with malignant biopsy
Time frame: 2 years
result of the biopsy of the BIRADS 4 breast
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katja Pinker-Domenig, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Benign, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with malignant biopsy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.