NEW YORK (GenomeWeb) – The National Cancer Institute has awarded researchers from Thomas Jefferson University a five-year, $2.7 million grant to conduct a multicenter study of a new single circulating tumor cell (CTC) analysis pipeline in metastatic breast cancer patients.
According to principal investigator Hushan Yang, he and his colleagues have developed a new approach for single CTC analysis that incorporates two existing technologies sold by Italy's Menarini-Silicon Biosystems: CellSearch, a US Food and Drug Administration-cleared system for detecting and enumerating CTCs; and DEPArray, a cell sorting and isolation instrument. After CTCs are enriched, enumerated, and isolated, they then undergo a novel amplification and next-generation sequencing process developed by Yang and his collaborators.
Specific details of the amplification and sequencing process remain undisclosed, but Yang told GenomeWeb that it involves "a statistical framework to jointly model the data from multiple CTCs, leveraging ... empirically derived error distributions as the priors to further increase the sensitivity and specificity of census-based mutation calling."
In the NCI-funded study, Yang and his team aim to use this pipeline to analyze CTCs collected from 300 metastatic breast cancer patients and 200 non-metastatic breast cancer patients within the Sidney Kimmel Cancer Network. Approximately 80 percent of trial enrollees are expected to have estrogen receptor-positive disease, with the remainder including ER negative and triple negative breast cancer patients. The researchers plan to collect three to five blood samples per patient annually over five years.
Yang noted that, to his knowledge, the trial represents the first population study of single CTC NGS analysis in metastatic breast cancer patients. And while data generated in the study will not be used to guide the treatment of participants, he added, they may help advance the use of CTCs for personalizing cancer therapies in future trials.
The grant began on Aug. 15 and runs until July 31, 2022. Yang's collaborators include the Vanderbilt Genetics Institute's Bingshan Li and Northwestern University's Massimo Cristofanilli.