120 Participants Needed

Pre-analytical Factors Affecting CtDNA Analysis in Early and Locally Advanced Breast Cancer

CT
Overseen ByClinical Trials Referral Office
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Mayo Clinic
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This study evaluates pre-analytical factors affecting circulating tumor deoxyribonucleic acid (ctDNA) analysis in breast cancer that not spread beyond the breast and or lymph nodes (early and locally advanced). ctDNA refers to freely circulating tumor DNA fragments found in the blood plasma. Pre-analytical factors such as blood collection tubes, delays in separation of plasma, centrifugation speeds, storage conditions, shipping and DNA extraction methods can all affect ctDNA measurements. Inappropriate processing can cause breaking down of the membrane (lysis) of peripheral blood cells that release background wild-type DNA and may also cause degradation of circulating tumor-specific DNA fragments. Both mechanisms will dilute levels of ctDNA in plasma and make it more difficult to detect. Evaluating the pre-analytical factors of the collection of blood and left over tissue samples for the research of cancer may help researchers to evaluate the impact of the blood collection/processing and long-term storage from patients with locally advanced breast cancer.

Research Team

BA

Barbara A. Pockaj, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

Inclusion Criteria

All women > 18 years of age
Stage I-III breast cancer
Subject has consented to IRB 2130-00 Tissue Registry

Treatment Details

Participant Groups
1Treatment groups
Experimental Treatment
Group I: Observational (Biospecimen collection, medical record)Experimental Treatment2 Interventions
Patients undergo blood sample collection throughout the study. Patients also undergo collection of leftover tissue samples from SOC procedures and have medical records reviewed.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+