Feasibility Study Aiming at Pre-Analytical Standardization of Whole Blood Processing for Liquid Biopsy Applications

Study Overview
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Brief Summary
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The goal of this feasibility study is to evaluate a new sample preparator called See.d. After blood processing the instrument will produce a set of slides and a tube of plasma. These outputs could be used in further analysis in liquid biopsy applications.

Detailed Description
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This feasibility study aims at the evaluation of a new instrument called See.d , to be used in conjunction with its accessories, Smart Bio Surface (SBS) slides and reagents, for preparation of cytological samples (seeded on SBS slides) and plasma from fresh whole blood (within 4-6 hours from collection). Blood samples will be collected from healthy volunteers and will be used to test See.d performances. Moreover the possibility of develop a new version of the instrument with increased processing capability and to develop and optimize analytical protocols for liquid biopsy applications will be evaluated as exploratory objectives. The only study procedure will be the collection of a blood sample from each participants; during this study 200 participants will be enrolled. For its feasibility nature, no formal statistics has been planned for this study.

Official Title
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Feasibility Study Aiming at Pre-Analytical Standardization of Whole Blood Processing for Liquid Biopsy Applications

Conditions
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Healthy Participants

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants are willing and able to give and sign a written informed consent Aged 18 or above Exclusion Criteria: Ongoing infections requiring antibiotic or antiviral treatment Known hemostasis/coagulation disorder Known Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy donors<br>Participants who are in good health and willing to provide a blood sample | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SBS slides stability | Evaluation of the area of adhered cell nuclei on SBS slides | 1 day (at the blood draw) | 
| Reagents stability | Evaluation of total adhered cell count on SBS slides | 1 day (at the blood draw) | 
| cfDNA quality control | Evaluation of the ratio between cfDNA and genomic contaminant DNA | 1 day (at the blood draw) | 
| Feasibility of staining on slides produced by See.d | Qualitative assessment of staining positivity | 1 day (at the blood draw) | 
| Feasibility of using See.d SBS slides for subsequent analysis | Recovery of mock-Circulating Tumor Cells (CTCs) | 1 day (at the blood draw) | 
| Feasibility of using See.d plasma for subsequent analysis | Recovery of spiked reference DNA | 1 day (at the blood draw) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Plasma, White Blood Cells, Pre-Analytical Standardization, Whole Blood, Liquid Biopsy