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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Provista Diagnostics, Inc
Sponsor:
Information provided by (Responsible Party):
Provista Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT02078570
First received: February 28, 2014
Last updated: November 10, 2014
Last verified: November 2014

February 28, 2014
November 10, 2014
March 2014
December 2014   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT02078570 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
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Breast Cancer Biomarker Sample Collection for the dtectDx v2 Assay Proof of Concept Protocol
Not Provided

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

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

Non-Probability Sample

Primary Care Clinics

Breast Cancer
Not Provided
Breast Cancer ACR BI-RAD Category 3 or 4 result
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
Not Provided
December 2014   (final data collection date for primary outcome measure)

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.
Female
25 Years to 75 Years
No
Contact: Sherri Borman 480-344-9210 bormans@provistadx.com
United States
 
NCT02078570
dtectDx-Breast-002
Not Provided
Provista Diagnostics, Inc
Provista Diagnostics, Inc
Not Provided
Not Provided
Provista Diagnostics, Inc
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP