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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05942066

Enrollment

200

Registered

2023-07-12

Start date

2023-10-09

Completion date

2027-07-01

Last updated

2026-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Participants

Keywords

Whole Blood, Liquid Biopsy, Plasma, White Blood Cells, Pre-Analytical Standardization

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

Italy

Contacts

CONTACTLuca Santoleri

MEDICI.CDS@HSR.IT02 2643 2340

PRINCIPAL_INVESTIGATORLuca Santoleri, MD

Ospedale San Raffaele

Outcome results