NCT02078570

Brief Summary

The major purpose of this study is to evaluate a laboratory developed test that measures multiple breast cancer-specific biomarker proteins and multiple antibodies in your blood samples. The biomarker and antibody results along with your personal medical profile will be evaluated to determine your risk for the presence of a malignancy in the breast as compared to your breast evaluation assessment conducted by your physician.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

12 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 28, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Last Updated

September 30, 2016

Status Verified

November 1, 2015

Enrollment Period

3.3 years

First QC Date

February 28, 2014

Last Update Submit

September 29, 2016

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Quantitative Protein Algorithmic Score (QPAS)

    Part I: Establish an acceptable algorithm for the generation of a single numerical score from the combination of the 10 cancer biomarkers that comprise the dtectDx Breast v2.0 Assay Part II: Define a numerical score cutoff that differentiates malignant from nonmalignant breast cancer in this population of woman

    Baseline

  • Modified Quantitative Protein Algorithmic Score (QPAS)

    Demonstrate proof-of-concept for use of the dtectDx-Breast Assay to assess likelihood of breast cancer malignancy in conjunction with the physicians clinical and radiological evaluations.

    6 Months

Secondary Outcomes (1)

  • QPAS relative to BI-RADS

    Baseline

Study Arms (1)

Breast Cancer ACR BI-RAD Category 3 or 4 result

Eligibility Criteria

Age25 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinics

You may qualify if:

  • Adult women from 25 years of age to below 75 years of age
  • Breast evaluation results of ACR BI-RADS® Category 3 or 4 by imaging and physicians clinical and radiological evaluation
  • Study visit and blood collection within 4 weeks (28 days) of ACR BI-RADS assessment
  • Patient agrees to with additional health data being gathered at 6 months post assessment for diagnostic follow-up
  • Samples collected under IRB approval and Informed Consent
  • Testing performed under IRB approval or waiver (as applicable)
  • Previous approved procedures to enroll patients: breast augmentation \& cyst aspiration

You may not qualify if:

  • Adults from 76 years of age or older and below 25 years of age
  • Final breast evaluation results other than a ACR BI-RADS Category 3 or 4
  • Subjects that have had a breast biopsy performed during the 6 months prior to the study visit
  • Samples not collected under IRB approval and Informed Consent
  • Testing not performed under IRB approval or waiver (as applicable)
  • Prior breast cancer diagnosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

St. Joseph's Hospital & Medical Center

Phoenix, Arizona, 85013, United States

Location

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Sutter Institute

Sacramento, California, 95816, United States

Location

Scripps

San Diego, California, 92103, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Sinai Grace

Detroit, Michigan, 48235, United States

Location

Mayo Clinic - Rochester

Rochester, Minnesota, 55095, United States

Location

Summit Medical Group Breast Center New Jersey

Berkeley Heights, New Jersey, 07922, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Mercy Womens Center

Oklahoma City, Oklahoma, 73120, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Avera Research Institute

Sioux Falls, South Dakota, 57105, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

35mL or 2 1/2 tablespoons of blood will be drawn from your arm

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2014

First Posted

March 5, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2017

Last Updated

September 30, 2016

Record last verified: 2015-11

Locations

US(12)