This study aims to evaluate the feasibility of using See.d instrument and SBS slides for preparation of plasma and cytological samples from whole blood. Forty-five participants will be enrolled (20 healthy volunteers and 25 metastatic breast cancer patients) and each participant will be asked to provide a blood sample.
The goal of this study is the evaluation of a new instrument called See.d, to be used in conjunction with its accessories, Smart Bio Surface (SBS) slides, for preparation of cytological samples (seeded on SBS slides) and plasma from fresh whole blood (within 4-6 hours from collection). Blood samples collected from healthy volunteers will be spiked-in with reference DNA and mock-CTC to mimic a patient sample in order to evaluate the instrument performance through the analysis of several parameters. Blood samples from Metastatic Breast Cancer (MBC) patients will be processed with See.d instrument installed in a clinical context to perform a preliminary analytical characterization of either cell-free DNA (cfDNA) and Circulating Tumor Cells (CTC). For its feasibility nature, no formal statistics has been planned for this study.
Study Type
OBSERVATIONAL
Enrollment
45
IEO
Milan, Italy
RECRUITINGEvaluation of White Blood Cells adhered on SBS slides
Evaluation of total adhered cell count on SBS slides
Time frame: 1 day (at the blood draw)
SBS slides stability
Evaluation of the area of adhered cell nuclei on SBS slides
Time frame: 1 day (at the blood draw)]
cfDNA quality control
Evaluation of the ratio between cfDNA and genomic contaminant DNA
Time frame: 1 day (at the blood draw)
Feasibility of using See.d SBS slides for subsequent analysis
Recovery of putative Circulating Tumor Cells (CTCs)
Time frame: 1 day (at the blood draw)
Feasibility of using See.d plasma for subsequent analysis
Detection of already known DNA mutations
Time frame: 1 day (at the blood draw)
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