Clinical trial NCT05942066: Feasibility Study Aiming at Pre-Analytical Standardization of Whole Blood Processing for Liquid Biopsy Applications
Official title: Feasibility Study Aiming at Pre-Analytical Standardization of Whole Blood Processing for Liquid Biopsy Applications
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Healthy Participants
Keywords: Whole Blood
Liquid Biopsy
Plasma
White Blood Cells
Pre-Analytical Standardization
Lead sponsor: Tethis S.p.A.
Sponsor class: INDUSTRY
First posted: 2023-07-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Blood samples to be used in this clinical study will be collected from healthy volunteers, already willing to become blood donors and, for this reason, already going to be subjected to a venipuncture and a blood draw to evaluate their eligibility to blood donation

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.

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

Primary outcomes:
measure: SBS slides stability
timeFrame: 1 day (at the blood draw)
measure: Reagents stability
timeFrame: 1 day (at the blood draw)
measure: cfDNA quality control
timeFrame: 1 day (at the blood draw)
measure: Feasibility of staining on slides produced by See.d
timeFrame: 1 day (at the blood draw)
measure: Feasibility of using See.d SBS slides for subsequent analysis
timeFrame: 1 day (at the blood draw)
measure: Feasibility of using See.d plasma for subsequent analysis
timeFrame: 1 day (at the blood draw)
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Ospedale San Raffaele
Study officials:
affiliation: Ospedale San Raffaele
name: Luca Santoleri, MD
role: PRINCIPAL_INVESTIGATOR
References:
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