NCT03147430

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

May 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2017

Completed
8.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

June 6, 2025

Status Verified

May 1, 2025

Enrollment Period

8.7 years

First QC Date

May 1, 2017

Last Update Submit

June 5, 2025

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Determine Accuracy

    1 week (from mammogram to biospy)

  • Determine Precision

    1 week (from mammogram to biospy)

  • Discover additional protein markers

    Duration of Study, estimated 2 years

  • Compare protein markers

    Duration of Study, estimated 2 years

Study Arms (2)

Invasive Cancer

Invasive cancer confirmed by biopsy

Other: Biomarkers

Benign or pre-invasive lesion

Benign or pre-invasive lesion confirmed by biopsy

Other: Biomarkers

Interventions

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.

Benign or pre-invasive lesionInvasive Cancer

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen who receive a suspicious mammogram report for breast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dorothy G Hoefer Comprehensive Breast Center

Newport News, Virginia, 23606, United States

Location

Sentara Norfolk General Breast Center

Norfolk, Virginia, 23507, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Surgical tissue specimen slides, blood and saliva.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Biomarkers

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Biological Factors

Study Officials

  • Richard Hoefer, DO

    Sentara Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2017

First Posted

May 10, 2017

Study Start

May 8, 2017

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

June 6, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(2)