Breast Cancer Biomarker Sample Collection for the dtectDx Assay Verification
2 other identifiers
observational
350
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2013
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 5, 2013
CompletedFirst Posted
Study publicly available on registry
April 24, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedJune 9, 2014
June 1, 2014
1.3 years
April 5, 2013
June 6, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Training
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.
Baseline
Blinded Validation
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
Secondary Outcomes (1)
Clinical Sensitivity/Specificity
Baseline
Study Arms (1)
Breast Cancer
ACR BI-RAD Category 3 or 4 result
Eligibility Criteria
Primary Care Clinics
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Banner Health
Phoenix, Arizona, 85006, United States
Sutter Institute
Sacramento, California, 95816, United States
Scripps
San Diego, California, 92103, United States
Sansum Clinic
Santa Barbara, California, 93102-1200, United States
Lahey Clinic
Peabody, Massachusetts, 01960, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Avera Research Institute
Sioux Falls, South Dakota, 57105, United States
Related Links
Biospecimen
At each visit, 35mL or 2 1/2 tablespoons of blood will be drawn from your arm.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2013
First Posted
April 24, 2013
Study Start
March 1, 2013
Primary Completion
June 1, 2014
Study Completion
August 1, 2014
Last Updated
June 9, 2014
Record last verified: 2014-06