Breast Cancer Biomarker Sample Collection for the dtectDx v2 Assay Proof of Concept Protocol

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator Karthik Ghosh, M.D.	Closed for enrollment	Contact information: Cancer Center Clinical Trials Referral Office 855-776-0015
Scottsdale/Phoenix, Ariz. Mayo Clinic principal investigator Donald Northfelt, M.D.	Closed for enrollment	Contact information: Cancer Center Clinical Trials Referral Office 855-776-0015

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

Karthik Ghosh, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Donald Northfelt, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

More information

Publications

Publications are currently not available

Clinical Trials