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

Anatomic Stage III Breast Cancer AJCC v8 Clinical Trial

Official title:
Pre-Analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer

Clinical Trial Summary

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.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To evaluate the impact of blood collection/processing. II. To evaluate the impact of long-term storage of plasma and extracted DNA. OUTLINE: This is an observational study. Patients undergo blood sample collection throughout the study. Patients also undergo collection of leftover tissue samples from standard of care (SOC) procedures and have medical records reviewed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05945290
Study type Observational
Source Mayo Clinic
Contact
Status Recruiting
Phase
Start date July 7, 2022
Completion date December 2025
View Details
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