期刊
CANCERS
卷 14, 期 21, 页码 -出版社
MDPI
DOI: 10.3390/cancers14215238
关键词
circulating tumor cells; neoplastic cells; circulating; neoplasms/diagnosis; circulating/pathology; biopsy; breast neoplasms/pathology; biomarkers; tumor; blood; liquid biopsy
类别
资金
- ANGLE Europe Limited
- Breast Cancer Research Program [BCRF-20, BCRF-21, 22-132]
- Tower Cancer Research Program [006886-0001]
- Miriam and Sheldon G. Adelson Medical Research Program
This study tested the ability of a semi-automated device to capture CTCs from peripheral blood based on cell size and deformability, and found methods to evaluate the captured CTCs. The data from this study were used to support the FDA classification request for the device, and demonstrated its effectiveness in capturing and evaluating CTCs from MBC patients.
Circulating tumor cells (CTCs) captured from the blood of cancer patients may serve as a surrogate source of tumor material that can be obtained via a venipuncture (also known as a liquid biopsy) and used to better understand tumor characteristics. However, the only FDA-cleared CTC assay has been limited to the enumeration of surface marker-defined cells and not further characterization of the CTCs. In this study, we tested the ability of a semi-automated device capable of capturing and harvesting CTCs from peripheral blood based on cell size and deformability, agnostic of cell-surface markers (the Parsortix (R) PC1 System), to yield CTCs for evaluation by downstream techniques commonly available in clinical laboratories. The data generated from this study were used to support a De Novo request (DEN200062) for the classification of this device, which the FDA recently granted. As part of a multicenter clinical trial, peripheral blood samples from 216 patients with metastatic breast cancer (MBC) and 205 healthy volunteers were subjected to CTC enrichment. A board-certified pathologist enumerated the CTCs from each participant by cytologic evaluation of Wright-Giemsa-stained slides. As proof of principle, cells harvested from a concurrent parallel sample provided by each participant were evaluated using one of three additional evaluation techniques: molecular profiling by qRT-PCR, RNA sequencing, or cytogenetic analysis of HER2 amplification by FISH. The study demonstrated that the Parsortix (R) PC1 System can effectively capture and harvest CTCs from the peripheral blood of MBC patients and that the harvested cells can be evaluated using orthogonal methodologies such as gene expression and/or Fluorescence In Situ Hybridization (FISH).
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据