Feasibility Study Aiming at Pre-Analytical Standardization of Whole Blood Processing for Liquid Biopsy Applications
Overview
- Phase
- Not Applicable
- Intervention
- Healthy donors
- Conditions
- Healthy Participants
- Sponsor
- Tethis S.p.A.
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- cfDNA quality control
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
Healthy donors
Participants who are in good health and willing to provide a blood sample
Outcomes
Primary Outcomes
cfDNA quality control
Time Frame: 1 day (at the blood draw)
Evaluation of the ratio between cfDNA and genomic contaminant DNA
Feasibility of staining on slides produced by See.d
Time Frame: 1 day (at the blood draw)
Qualitative assessment of staining positivity
Feasibility of using See.d SBS slides for subsequent analysis
Time Frame: 1 day (at the blood draw)
Recovery of mock-Circulating Tumor Cells (CTCs)
SBS slides stability
Time Frame: 1 day (at the blood draw)
Evaluation of the area of adhered cell nuclei on SBS slides
Reagents stability
Time Frame: 1 day (at the blood draw)
Evaluation of total adhered cell count on SBS slides
Feasibility of using See.d plasma for subsequent analysis
Time Frame: 1 day (at the blood draw)
Recovery of spiked reference DNA