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 June 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: June 6, 2014
Last verified: June 2014
  Purpose

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.


Condition
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: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast Cancer ACR BI-RAD Category 3 or 4 result

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT02078570

Contacts
Contact: Sherri Borman 480-344-9210 bormans@provistadx.com

Locations
United States, California
Scripps Not yet recruiting
San Diego, California, United States, 92103
Contact: Anna Valencerina    858-652-5538    Valencerina.MariaAnna@scrippshealth.org   
Contact: Alain Perez    858-554-9379    Perez.Alain@scrippshealth.org   
Principal Investigator: Carrie Constantini, MD         
United States, Michigan
Henry Ford Hospital Not yet recruiting
Detroit, Michigan, United States, 48202
Contact: Tiffany Pearce    313-916-1784    Tpearce1@hfh.edu   
Contact: Sheba Kurian    313-916-7277    Skurian2@hfhs.org   
Principal Investigator: Haythem Ali, MD         
Sub-Investigator: Biren Shah, MD         
United States, Oklahoma
Mercy Womens Center Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Alan Hollingsworth, MD    405-752-3500    Alan.Hollingsworth@mercy.net   
Contact: Paige Chiles    405-752-3531    Paige.Chiles@mercy.net   
Principal Investigator: Alan Hollingsworth, MD         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Diane Romano    401-444-7163    DRomano@lifespan.org   
Contact: Lila Camara    401-444-4677    lcamara@lifespan.org   
Principal Investigator: Ana Lourenco, MD         
United States, South Dakota
Avera Research Institute Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Heidi Demouth    605-322-3295    Heidi.Demouth@avera.org   
Contact: Daniel Norfolk    605-322-3291    Daniel.Norfolk@avera.org   
Principal Investigator: Josie Alpers, MD         
Sub-Investigator: Amy Krie, MD         
Sponsors and Collaborators
Provista Diagnostics, Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Provista Diagnostics, Inc
ClinicalTrials.gov Identifier: NCT02078570     History of Changes
Other Study ID Numbers: dtectDx-Breast-002
Study First Received: February 28, 2014
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 28, 2014