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NCT Number: NCT05942066

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

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.

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Key information

Conditions

Healthy Participants

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale San Raffaele

Milan, 20132, Italy

Location status: Recruiting

Location contact

Luca Santoleri, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. SBS slides stability

    Time frame: 1 day (at the blood draw)

    Evaluation of the area of adhered cell nuclei on SBS slides

  2. Reagents stability

    Time frame: 1 day (at the blood draw)

    Evaluation of total adhered cell count on SBS slides

  3. cfDNA quality control

    Time frame: 1 day (at the blood draw)

    Evaluation of the ratio between cfDNA and genomic contaminant DNA

  4. Feasibility of staining on slides produced by See.d

    Time frame: 1 day (at the blood draw)

    Qualitative assessment of staining positivity

  5. 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)

  6. Feasibility of using See.d plasma for subsequent analysis

    Time frame: 1 day (at the blood draw)

    Recovery of spiked reference DNA

Study contacts

Contact information is provided by the study sponsor or research team.

Luca Santoleri

CONTACT

[email protected]

02 2643 2340

Sponsors and collaborators

Lead sponsor

Tethis S.p.A.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 12, 2023
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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