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

Tethis

Status: Enrolling

Conditions: Healthy Participants

Study type: Observational

Funder types: Industry

Identifiers

NCT05942066

TET-23-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Healthy donors

Description:

Participants who are in good health and willing to provide a blood sample