Status:
UNKNOWN
Breast Cancer Biomarker Sample Collection for the dtectDx Assay Verification
Lead Sponsor:
Provista Diagnostics, Inc
Conditions:
Breast Cancer
Eligibility:
FEMALE
25-49 years
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...
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 m...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2014
Estimated Enrollment :
350 Patients enrolled
Trial Details
Trial ID
NCT01839045
Start Date
March 1 2013
End Date
August 1 2014
Last Update
June 9 2014
Active Locations (8)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner Health
Phoenix, Arizona, United States, 85006
2
Sutter Institute
Sacramento, California, United States, 95816
3
Scripps
San Diego, California, United States, 92103
4
Sansum Clinic
Santa Barbara, California, United States, 93102-1200