Breast Cancer Biomarker Sample Collection for the dtectDx v2 Assay Proof of Concept Protocol

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Provista Diagnostics, Inc Identifier:
First received: February 28, 2014
Last updated: November 3, 2015
Last verified: November 2015
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.

Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

Further study details as provided by Provista Diagnostics, Inc:

Primary Outcome Measures:
  • Quantitative Protein Algorithmic Score (QPAS) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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

  • Modified Quantitative Protein Algorithmic Score (QPAS) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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.

Secondary Outcome Measures:
  • QPAS relative to BI-RADS [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Demonstrate the numerical score, collaborated via proprietary algorithm , for the dtectDx-Breast Assay v2.0 increases the likelihood of malignant breast cancer detection when used adjunctively with the assessment of BI-RADS Categories 3 and 4 compared to the assessment of BI-RADS Categories 3 and 4 alone.

Biospecimen Retention:   Samples Without DNA
35mL or 2 1/2 tablespoons of blood will be drawn from your arm

Estimated Enrollment: 500
Study Start Date: March 2014
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Breast Cancer ACR BI-RAD Category 3 or 4 result


Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary Care Clinics

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02078570

United States, Arizona
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, United States, 85013
Mayo Clinic
Scottsdale, Arizona, United States, 85259
United States, California
Sutter Institute
Sacramento, California, United States, 95816
San Diego, California, United States, 92103
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Sinai Grace
Detroit, Michigan, United States, 48235
United States, Minnesota
Mayo Clinic - Rochester
Rochester, Minnesota, United States, 55095
United States, New Jersey
Summit Medical Group Breast Center New Jersey
Berkeley Heights, New Jersey, United States, 07922
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oklahoma
Mercy Womens Center
Oklahoma City, Oklahoma, United States, 73120
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Dakota
Avera Research Institute
Sioux Falls, South Dakota, United States, 57105
Sponsors and Collaborators
Provista Diagnostics, Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Provista Diagnostics, Inc Identifier: NCT02078570     History of Changes
Other Study ID Numbers: dtectDx-Breast-002
Study First Received: February 28, 2014
Last Updated: November 3, 2015
Health Authority: United States: Food and Drug Administration processed this record on November 27, 2015