Pre-Analytical Factors Affecting ctDNA Analysis in Early and Locally Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Change in tumor specific circulating tumor deoxyribonucleic acid (ctDNA) levels
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All women > 18 years of age
- •Stage I-III breast cancer
- •Subject has consented to IRB 2130-00 Tissue Registry
排除标准
- •Stage IV breast cancer
- •Unwilling or unable to give consent
- •Unable to participate for 1 year
- •No one with a concurrent cancer except those diagnosed with an in situ cancer or non-melanoma skin cancer
结局指标
主要结局
Change in tumor specific circulating tumor deoxyribonucleic acid (ctDNA) levels
时间窗: Baseline to 5 years
Will be measured as tumor fraction (%), using TARgeted DIgital Sequencing (TARDIS).
次要结局
- Change in total cell-free DNA concentration(Baseline to 5 years)
- Background error rate(Baseline to 5 years)
- Change in tumor-specific circulating tumor deoxyribonucleic acid (ctDNA) fragment size profile(Baseline to 5 years)
- Change in total cell-free DNA fragment size profile(Baseline to 5 years)