Breast Cancer Biomarker Sample Collection for the dtectDx Assay Verification

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Provista Diagnostics, Inc
ClinicalTrials.gov Identifier:
NCT01839045
First received: April 5, 2013
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 in your blood samples. The biomarker 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 [Patient Registry]
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Breast Cancer Biomarker Sample Collection for the DtectDx Assay Proof of Concept

Resource links provided by NLM:


Further study details as provided by Provista Diagnostics, Inc:

Primary Outcome Measures:
  • Training [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Part I: Establish an acceptable algorithm for generation of a single numerical score from the combination of the 5 cancer biomarkers that comprise the dtectDX-Breast Assay Part II: Define a numerical score cutoff that differentiates malignant from nonmalignant breast cancer in this population of woman.

  • Blinded Validation [ 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:
  • Clinical Sensitivity/Specificity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Demonstrate the numerical score, collaborated via proprietary algorithm (greater then 60 is an elevated score, less then 60 is a normal score), for the dtectDx-Breast Assay 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

At each visit, 35mL or 2 1/2 tablespoons of blood will be drawn from your arm.


Estimated Enrollment: 350
Study Start Date: March 2013
Estimated Study Completion Date: August 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast Cancer
ACR BI-RAD Category 3 or 4 result

Detailed Description:

As part of the study, 35 mL or 2 1/2 tablespoons of blood will be drawn from your arm at each study visit.

This study has 2 visits. Visit 1 will take about 1 hour. Visit 2 is a follow up visit at 6 months taking about 1 hour.

Visit 1- Screening and Blood Collection:

The following procedures will be done at the clinical research facility:

  • The study doctor and/or study staff will explain the study and all the study procedures.
  • You will be asked to review, sign and date this informed consent before any procedures are done.
  • The study doctor and/or study staff will ask you questions about your health status and medical history and record this information.
  • 35 mL or 2 ½ tablespoons of blood will be collected from your arm.
  • The samples will not be labeled with your name but a unique identification code, which means they will be given a number which can be linked to you.

Visit 2 - Follow up:

If you have been diagnosed with cancer between visit 1 and visit 2, you will not be required to complete visit 2. If you have been diagnosed with LCIS or DCIS, you will be requested to return for visit 2. Otherwise you will return to the center for visit 2.

The following procedures will be performed:

  • You will have a follow-up breast evaluation performed. Your follow-up breast evaluation may occur prior to Visit 2 if you have it performed at a different facility or it may be performed during this study visit.
  • The study doctor and/or study staff will assess your health and medical history.
  • 35 mL or 2 1/2 tablespoons of blood will be collected from your arm.
  • The samples will not be labeled with your name but a unique identification code, which means they will be given a number which can be linked to you.

Your blood sample will be sent to the study Sponsor, Provista Diagnostics, Inc. for testing.

The test results will not be reported back to the study doctor and will not be used to determine or change your treatment. This testing will be done in addition to any routine testing that your study doctor performs. You will not receive the results of these tests.

Up to 350 subjects will take part in this study. Patients will be enrolled at one of seven sites.

  Eligibility

Ages Eligible for Study:   25 Years to 49 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 50 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 3 weeks (21 days) of ACR BI-RADS assessment
  • Patient agrees to return for diagnostic follow-up and blood collection at 6 months unless a positive cancer diagnosis is made between study visits 1 and 2. Individuals diagnosed with LCIS and DCIS will agree to return for visit 2
  • Samples collected under IRB approval and Informed Consent
  • Testing performed under IRB approval or waiver (as applicable)

Exclusion Criteria:

  • Adults from 50 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 at any time 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: NCT01839045

Locations
United States, Arizona
Banner Health
Phoenix, Arizona, United States, 85006
United States, California
Sutter Institute
Sacramento, California, United States, 95816
Scripps
San Diego, California, United States, 92103
Sansum Clinic
Santa Barbara, California, United States, 93102-1200
United States, Massachusetts
Lahey Clinic
Peabody, Massachusetts, United States, 01960
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
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
ClinicalTrials.gov Identifier: NCT01839045     History of Changes
Other Study ID Numbers: dtectDx-Breast-001, ProvistaDx
Study First Received: April 5, 2013
Last Updated: June 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Provista Diagnostics, Inc:
Woman
Breast Cancer
Cancer
Mammogram
Ultrasound
Imaging
Biomarkers
ACR BI RAD Category 3
ACR BI RAD Category 4

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

ClinicalTrials.gov processed this record on October 21, 2014