Early Detection of Breast Cancer in Women With Suspicious Mammograms

Description

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.

Conditions

Breast Cancer

Study Overview

Study Details

Study overview

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.

Early Detection of Breast Cancer in Women With Suspicious Mammograms

Early Detection of Breast Cancer in Women With Suspicious Mammograms

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Newport News

Dorothy G Hoefer Comprehensive Breast Center, Newport News, Virginia, United States, 23606

Norfolk

Sentara Norfolk General Breast Center, Norfolk, Virginia, United States, 23507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sentara Norfolk General Hospital,

Richard Hoefer, DO, PRINCIPAL_INVESTIGATOR, Sentara Healthcare

Study Record Dates

2025-12-31