Early Detection of Breast Cancer in Women With Suspicious Mammograms

Breast Cancer Clinical Trial

Official title:

Early Detection of Breast Cancer in Women With Suspicious Mammograms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03147430
• Other study ID #: 16-09-EX-0146
• Status: Recruiting
• Start date: May 8, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: Sentara Norfolk General Hospital
• Contact: Kayla Kenke
• Phone: 757-388-2406
• Email: fkkenke[@]sentara.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Biomarkers
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.

Locations

Country	Name	City	State
United States	Dorothy G Hoefer Comprehensive Breast Center	Newport News	Virginia
United States	Sentara Norfolk General Breast Center	Norfolk	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Sentara Norfolk General Hospital	Dorothy G. Hoefer Foundation, George Mason University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Duration of Study, estimated 2 years
Secondary	Determine Accuracy	1. Determine percent accuracy of breast cancer diagnosis in the context of 3D mammographically (screen detected) tumors.	1 week (from mammogram to biospy)
Secondary	Determine Precision	2. Determine percent precision of cancer diagnosis in the context of 3D mammographically (screen detected) tumors.	1 week (from mammogram to biospy)
Secondary	Discover additional protein markers	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.	Duration of Study, estimated 2 years
Secondary	Compare protein markers	4. Additionally compare protein markers between patients with invasive cancer and pre-invasive neoplasms as determined by biopsy.	Duration of Study, estimated 2 years