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

September 29, 2016 updated by: Provista Diagnostics, Inc
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

25 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Primary Care Clinics

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast Cancer ACR BI-RAD Category 3 or 4 result

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative Protein Algorithmic Score (QPAS)
Time Frame: Baseline
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)
Time Frame: 6 Months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
QPAS relative to BI-RADS
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Provista Diagnostics, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

July 1, 2017

Study Registration Dates

First Submitted

February 28, 2014

First Submitted That Met QC Criteria

March 3, 2014

First Posted (Estimate)

March 5, 2014

Study Record Updates

Last Update Posted (Estimate)

September 30, 2016

Last Update Submitted That Met QC Criteria

September 29, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • dtectDx-Breast-002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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