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Breast Cancer Biomarker Sample Collection for the DtectDx Assay Proof of Concept


N/A
25 Years
49 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

Breast Cancer Biomarker Sample Collection for the DtectDx Assay Proof of Concept


This study has 2 visits. Visit 1 will be completed day of enrollment, taking about 1 hour.
Visit 2 is a follow up visit within 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 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.

- 35mL 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. Otherwise you will return to the center for visit 2.

The following procedures will be performed:

- You will have a follow-up mammogram test performed. The mammogram visit 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 doctor and/or study staff will assess your health and medical history.

- 35mL 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.


Inclusion Criteria:



- Adult women from 25 years of age to below 50 years of age

- Breast cancer screening mammography results of BI-RADS® Category 3 or 4

- Study visit and blood collection within 3 weeks (21 days) of screening mammogram.

- Diagnostic follow-up and blood collection within 6 months unless a positive cancer
diagnosis is made between study visits 1 and 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

- Breast cancer screening mammography results of BI-RADS® Category 0, 1, 2, 5, or 6

- Subjects that have had a biopsy performed 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 cancer diagnosis.

Type of Study:

Observational [Patient Registry]

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

Training

Outcome Description:

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.

Outcome Time Frame:

Baseline

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

dtectDx-Breast-001

NCT ID:

NCT01839045

Start Date:

March 2013

Completion Date:

April 2014

Related Keywords:

  • Breast Cancer
  • Woman
  • Breast Cancer
  • Cancer
  • Mammogram
  • Biomarkers
  • ACR BI RAD Category 3
  • ACR BI RAD Category 4
  • Breast Neoplasms

Name

Location

Rhode Island HospitalProvidence, Rhode Island  02903
Henry Ford HospitalDetroit, Michigan  48202
Avera Research InstituteSioux Falls, South Dakota  57105
Sansum ClinicSanta Barbara, California  93105
Banner HealthPhoenix, Arizona  85006
Sutter InstituteSacramento, California  95816
ScrippsSan Diego, California  92103