Early Detection of Breast Cancer in Women With Suspicious Mammograms
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/30/2018 |
| Start Date: | May 8, 2017 |
| End Date: | May 31, 2020 |
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.
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.
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:
1. Determine percent accuracy of breast cancer diagnosis in the context of 3D
mammographically (screen detected) tumors.
2. Determine percent precision of cancer diagnosis in the context of 3D mammographically
(screen detected) tumors.
3. 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.
4. Additionally compare protein markers between patients with invasive cancer and
pre-invasive neoplasms as determined by biopsy.
5. Bank samples for future research and sequencing.
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:
1. Determine percent accuracy of breast cancer diagnosis in the context of 3D
mammographically (screen detected) tumors.
2. Determine percent precision of cancer diagnosis in the context of 3D mammographically
(screen detected) tumors.
3. 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.
4. Additionally compare protein markers between patients with invasive cancer and
pre-invasive neoplasms as determined by biopsy.
5. Bank samples for future research and sequencing.
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
We found this trial at
1
site
11803 Jefferson Avenue
Newport News, Virginia 23606
Newport News, Virginia 23606
Principal Investigator: Richard Hoefer, DO
Phone: 757-388-5224
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