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

Breast Cancer Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02078570
• Other study ID #: dtectDx-Breast-002
• Status: Active, not recruiting
• Phase: N/A
• First received: February 28, 2014
• Last updated: September 29, 2016
• Start date: March 2014

Study information

• Verified date: November 2015
• Source: Provista Diagnostics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 500
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 75 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	Summit Medical Group Breast Center New Jersey	Berkeley Heights	New Jersey
United States	Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	Sinai Grace	Detroit	Michigan
United States	Mercy Womens Center	Oklahoma City	Oklahoma
United States	St. Joseph's Hospital & Medical Center	Phoenix	Arizona
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Mayo Clinic - Rochester	Rochester	Minnesota
United States	Sutter Institute	Sacramento	California
United States	Scripps	San Diego	California
United States	Mayo Clinic	Scottsdale	Arizona
United States	Avera Research Institute	Sioux Falls	South Dakota

Sponsors (1)

Lead Sponsor	Collaborator
Provista Diagnostics, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	QPAS relative to BI-RADS	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	No

External Links

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