Cell Free DNA Analysis and Circulating Tumor Cell Characterization in Metastatic Breast Cancer
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 16-001540
Sponsor Protocol Number: 16-001540
About this study
The objective of this study is to provide preliminary data to support the development of selected technologies for the efficient and reliable analyses of cell free DNA (cfDNA) and circulating tumor cells (CTCs) in the setting of metastatic breast cancer.
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:
- age 18 years or older
- histologic evidence of breast cancer with known hormone receptor and HER2 status
- initiation of new systemic therapy for progressive metastatic disease or unresectable locally recurrent disease within four weeks of the blood draw
- an understanding of the protocol and its requirements, risks, and discomforts
- the ability and willingness to sign an informed consent
- FFPE tumor tissue
Exclusion Criteria:
- pregnancy or lactation (for females)
- inability on the part of the patient to understand the informed consent or be compliant with the protocol
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 Giridhar, M.D. |
Closed for enrollment |
Contact information:
Center for Individualized Medicine
(507)293-0792
|
More information
Publications
Publications are currently not available