Detecting breast cancer early in women with suspicious mammograms
Early Detection of Breast Cancer in Women With Suspicious Mammograms
This study is trying to find new ways to detect breast cancer early in women who have received a concerning mammogram result.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Sentara Norfolk General Hospital Academic / other |
| Locations | 2 sites (Newport News, Virginia and 1 other locations) |
| Trial ID | NCT03147430 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on women who receive a suspicious mammogram report with a BIRADS rating of 4-5. Participants will provide blood and saliva samples, along with medical records and a medical history questionnaire, to aid in the search for diagnostic biomarkers. The study aims to follow participants for one year to monitor the progression or resolution of their suspicious findings. The ultimate goal is to improve early detection methods for breast cancer, which is crucial for enhancing treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who have received a suspicious mammogram report or are scheduled for further testing.
Not a fit: Patients with a known history of breast cancer or any other type of cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of breast cancer, potentially reducing mortality rates.
How similar studies have performed: While there have been studies focusing on early detection of breast cancer, the specific approach of identifying biomarkers in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Newport News, Virginia and 1 other locations
- Dorothy G Hoefer Comprehensive Breast Center — Newport News, Virginia, United States (Recruiting)
- Sentara Norfolk General Breast Center — Norfolk, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Richard Hoefer, DO — Sentara Healthcare
- Study coordinator: Kayla Kenke
- Email: fkkenke@sentara.com
- Phone: 757-388-2406
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.