Breast CancerNCT03147430
Early Detection of Breast Cancer in Women With Suspicious Mammograms
An observational study of Breast Cancer, run by Sentara Norfolk General Hospital at 2 sites in United States.
Trial summary
This is a non-treatment study. It will not involve the use of any investigational drug or device. Potential participants will be enrolled through direct contact with collaborating clinical sites when the patient's annual 3D mammogram report yields a BIRADS rating of 4-5. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Biomarkers
- How many people
- 270 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 May 2017to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: All participants will be enrolled through direct contact with collaborating clinical sites. In the first phase this study will strive to enroll 150 participants who are identified as having a suspicious mammogram. Review of the data for the first set of 150 patients revealed a set of biomarkers discovered and evaluated blindly that showed a strong statistical correlation with cancer versus non cancer in the final pathologic diagnosis. Based on this success, a decision is made by the PI to extend the study to enroll an additional 120 patients.
Who may be able to join
- Women who receive a suspicious mammogram report or are scheduled to receive testing for suspect breast area, with a subsequent biopsy to confirm diagnosis
- Willingness and ability to donate biospecimens for the purpose of propelling research.
- Participants aged ≥ 18.
Who cannot join
- Individuals under 18 years of age or over 89 years of age.
- A known history of breast cancer.
- A diagnosis or history of any other type of cancer.
- Participants who are male.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Dorothy G Hoefer Comprehensive Breast Center
Newport News, Virginia, 23606
Sentara Norfolk General Breast Center
Norfolk, Virginia, 23507
About this study
This is a non-treatment study. It will not involve the use of any investigational drug or device. Potential participants will be enrolled through direct contact with collaborating clinical sites when the patient's annual 3D mammogram report yields a BIRADS rating of 4-5. The clinical Investigators or a member of their staff will conduct consent discussion once a suspicious mammogram report is identified or if a patient is referred for imaging of a suspicious area in the breast. After consenting the participant will be asked to donate a blood sample, a saliva sample, medical records pertaining to the suspicious mammogram report and a medical history questionnaire. The participants will be followed after one year to capture progression or resolution of their suspicious mammogram report. After a biopsy confirms the diagnosis of cancer or benign lesion, a recut sample of the tissue may be requested for research.
Read the detailed description
Breast cancer is a leading cause of cancer mortality in women worldwide. According to estimates, approximately 46,000 women in the United States, and 130,000 women in the European Union, die due to breast cancer yearly. Early detection is of paramount importance in reducing mortality from this major public health burden. Screening mammography has been shown to reduce breast cancer mortality by 20% to 35% in women aged 40 to 69 years. Detection of small volume breast cancer at early stages is associated with a 10-year disease-free survival rate as high as 98% in patients with pT1a,bN0M0 tumors (measuring 1 cm or less, with disease-free axillary lymph nodes and no distant metastasis). The assumption that early diagnosis will lead to improved treatment outcomes has driven the search for diagnostic biomarkers.
Despite this enthusiasm, a biomarker for stage I breast cancer has been elusive. The predictive value of mammography declines in cohorts of patients with denser breast tissue and smaller lesions, and recent studies have indicated that the small amount of biomarker molecules emanating from a breast tumor of less than 1 cm is well below the sensitivity of detection for current analytical methods. In addition, biomarkers in body fluids are highly perishable. Biomarkers break down during collection, transport and storage due to endogenous degradative enzymes yielding false negatives. Thus there is a significant need for new technologies that will a) identify and measure low abundance biomarkers (less than 1 nanogram/mL), and b) is low cost and can be seamlessly integrated into the clinical workflow.
Primary Objective:
The primary goal of this study is to a) experimentally discover putative plasma markers for detecting early, stage I breast cancer in the setting of a suspicious mammogram and distinguish those cancers from benign lesions b) verify the putative markers through molecular profiling; and c) validate the markers by mass spectrometry.
Secondary Objectives:
- Determine percent accuracy of breast cancer diagnosis in the context of 3D mammographically (screen detected) tumors.
- Determine percent precision of cancer diagnosis in the context of 3D mammographically (screen detected) tumors.
- Discover additional protein markers of early stage breast cancer that distinguish these tumors from benign lesions identified by mammography by comparing protein markers between patients with invasive cancer vs. benign tumors as determined by biopsy.
- Additionally compare protein markers between patients with invasive cancer and pre-invasive neoplasms as determined by biopsy.
- Bank samples for future research and sequencing.
- Conditions
- Breast Cancer
- Being tested
- Biomarkers
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BiomarkersOther
Experimentally discover putative plasma markers for detecting early, stage I breast cancer in the setting of a suspicious mammogram and distinguish those cancers from benign lesions b) verify the putative markers through molecular profiling; and c) validate the markers by mass spectrometry.
| Study group | Role | What they receive |
|---|---|---|
| Invasive Cancer | Invasive cancer confirmed by biopsy Receives: Other: Biomarkers | |
| Benign or pre-invasive lesion | Benign or pre-invasive lesion confirmed by biopsy Receives: Other: Biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify markers to differentiate cancers from benign lesions
Experimentally discover putative plasma markers for detecting early, stage I breast cancer in the setting of a suspicious mammogram and distinguish those cancers from benign lesions, verify the putative markers through molecular profiling; and validate the markers by mass spectrometry.
Measured: Duration of Study, estimated 2 years
Secondary outcomes (4)
Determine Accuracy
- Determine percent accuracy of breast cancer diagnosis in the context of 3D mammographically (screen detected) tumors.
Measured: 1 week (from mammogram to biospy)
Determine Precision
- Determine percent precision of cancer diagnosis in the context of 3D mammographically (screen detected) tumors.
Measured: 1 week (from mammogram to biospy)
Discover additional protein markers
- Discover additional protein markers of early stage breast cancer that distinguish these tumors from benign lesions identified by mammography by comparing protein markers between patients with invasive cancer vs. benign tumors as determined by biopsy.
Measured: Duration of Study, estimated 2 years
Compare protein markers
- Additionally compare protein markers between patients with invasive cancer and pre-invasive neoplasms as determined by biopsy.
Measured: Duration of Study, estimated 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start8 May 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
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.
- 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
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sentara Norfolk General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dorothy G. Hoefer Foundation, George Mason University
- Responsible party
- Sponsor
- Investigators
- Richard Hoefer, DO, Principal investigator, Sentara Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147430
- Sponsor's protocol ID
- 16-09-EX-0146
- Status last verified
- May 2025
- First submitted
- 1 May 2017
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Breast Cancer in Women With Suspicious Mammograms
- ClinicalTrials.gov ID
- NCT03147430
- Acronym / sponsor ID
- 16-09-EX-0146
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Sentara Norfolk General HospitalUniversity, hospital or other
- Collaborators
- Dorothy G. Hoefer Foundation, George Mason University
- Study start
- 8 May 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 May 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.
This is a non-treatment study. It will not involve the use of any investigational drug or device. Potential participants will be enrolled through direct contact with collaborating clinical sites when the patient's annual 3D mammogram report yields a BIRADS rating of 4-5. The clinical Investigators or a member of their staff will conduct consent discussion once a suspicious mammogram report is identified or if a patient is referred for imaging of a suspicious area in the breast. After consenting the participant will be asked to donate a blood sample, a saliva sample, medical records pertaining to the suspicious mammogram report and a medical history questionnaire. The participants will be followed after one year to capture progression or resolution of their suspicious mammogram report. After a biopsy confirms the diagnosis of cancer or benign lesion, a recut sample of the tissue may be requested for research.
Detailed description
Breast cancer is a leading cause of cancer mortality in women worldwide. According to estimates, approximately 46,000 women in the United States, and 130,000 women in the European Union, die due to breast cancer yearly. Early detection is of paramount importance in reducing mortality from this major public health burden. Screening mammography has been shown to reduce breast cancer mortality by 20% to 35% in women aged 40 to 69 years. Detection of small volume breast cancer at early stages is associated with a 10-year disease-free survival rate as high as 98% in patients with pT1a,bN0M0 tumors (measuring 1 cm or less, with disease-free axillary lymph nodes and no distant metastasis). The assumption that early diagnosis will lead to improved treatment outcomes has driven the search for diagnostic biomarkers.
Despite this enthusiasm, a biomarker for stage I breast cancer has been elusive. The predictive value of mammography declines in cohorts of patients with denser breast tissue and smaller lesions, and recent studies have indicated that the small amount of biomarker molecules emanating from a breast tumor of less than 1 cm is well below the sensitivity of detection for current analytical methods. In addition, biomarkers in body fluids are highly perishable. Biomarkers break down during collection, transport and storage due to endogenous degradative enzymes yielding false negatives. Thus there is a significant need for new technologies that will a) identify and measure low abundance biomarkers (less than 1 nanogram/mL), and b) is low cost and can be seamlessly integrated into the clinical workflow.
Primary Objective:
The primary goal of this study is to a) experimentally discover putative plasma markers for detecting early, stage I breast cancer in the setting of a suspicious mammogram and distinguish those cancers from benign lesions b) verify the putative markers through molecular profiling; and c) validate the markers by mass spectrometry.
Secondary Objectives:
- Determine percent accuracy of breast cancer diagnosis in the context of 3D mammographically (screen detected) tumors.
- Determine percent precision of cancer diagnosis in the context of 3D mammographically (screen detected) tumors.
- Discover additional protein markers of early stage breast cancer that distinguish these tumors from benign lesions identified by mammography by comparing protein markers between patients with invasive cancer vs. benign tumors as determined by biopsy.
- Additionally compare protein markers between patients with invasive cancer and pre-invasive neoplasms as determined by biopsy.
- Bank samples for future research and sequencing.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Invasive Cancer | – | Other: BiomarkersInvasive cancer confirmed by biopsy |
| Benign or pre-invasive lesion | – | Other: BiomarkersBenign or pre-invasive lesion confirmed by biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All participants will be enrolled through direct contact with collaborating clinical sites. In the first phase this study will strive to enroll 150 participants who are identified as having a suspicious mammogram. Review of the data for the first set of 150 patients revealed a set of biomarkers discovered and evaluated blindly that showed a strong statistical correlation with cancer versus non cancer in the final pathologic diagnosis. Based on this success, a decision is made by the PI to extend the study to enroll an additional 120 patients.
Key inclusion criteria (3 listed)
- Women who receive a suspicious mammogram report or are scheduled to receive testing for suspect breast area, with a subsequent biopsy to confirm diagnosis
- Willingness and ability to donate biospecimens for the purpose of propelling research.
- Participants aged ≥ 18.
Key exclusion criteria (4 listed)
- Individuals under 18 years of age or over 89 years of age.
- A known history of breast cancer.
- A diagnosis or history of any other type of cancer.
- Participants who are male.
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 |
|---|---|---|
| BiomarkersExperimentally discover putative plasma markers for detecting early, stage I breast cancer in the setting of a suspicious mammogram and distinguish those cancers from benign lesions b) verify the putative markers through molecular profiling; and c) validate the markers by mass spectrometry. | Other | Benign or pre-invasive lesion, Invasive Cancer |
Primary outcome
Identify markers to differentiate cancers from benign lesions
Time frame: Duration of Study, estimated 2 years
Experimentally discover putative plasma markers for detecting early, stage I breast cancer in the setting of a suspicious mammogram and distinguish those cancers from benign lesions, verify the putative markers through molecular profiling; and validate the markers by mass spectrometry.
4 secondary outcomes
Determine Accuracy
Time frame: 1 week (from mammogram to biospy)
Determine Precision
Time frame: 1 week (from mammogram to biospy)
Discover additional protein markers
Time frame: Duration of Study, estimated 2 years
Compare protein markers
Time frame: Duration of Study, estimated 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Richard Hoefer, DO principal investigator
Sentara Healthcare
2 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, run by Sentara Norfolk General Hospital at 2 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 3 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
This study is still under way. Results are not available in the source record yet.
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?
Identify markers to differentiate cancers from benign lesions (time frame: Duration of Study, estimated 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 6 Jun 2025.