Actively Recruiting

Age: 18Years +
All Genders
Healthy Volunteers
NCT06097156

Evaluation of See.d as an Automated Blood Sample Preparator for Multiple Liquid Biopsy Applications

Led by Tethis S.p.A. · Updated on 2026-01-30

45

Participants Needed

1

Research Sites

160 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study aims to evaluate the feasibility of using See.d instrument and SBS slides for preparation of plasma and cytological samples from whole blood. Forty-five participants will be enrolled (20 healthy volunteers and 25 metastatic breast cancer patients) and each participant will be asked to provide a blood sample.

CONDITIONS

Official Title

Evaluation of See.d as an Automated Blood Sample Preparator for Multiple Liquid Biopsy Applications

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participants is willing and able to give and sign a written informed consent
  • Aged 18 or above
  • Female metastatic breast cancer patients aged 18 or above
  • Histological confirmation of breast cancer
  • Presence of at least one non-bone metastasis
  • Disease in clinical or radiologic progression to the last line of treatment as evaluated by the investigator
  • Biopsy scheduled within 4 weeks after blood withdrawal when recommended
  • Last biopsy or minor surgery performed at least 7 days before blood withdrawal
  • Known bilirubin level 6 2 mg/dL on blood sample collected within 7 days from enrolment (if unavailable, bilirubin assessment not necessary)
  • Healthy volunteers of both sexes aged 18 or above
  • Healthy participants visiting site for reasons other than cancer diagnosis (including breast cancer)
Not Eligible

You will not qualify if you...

  • Ongoing infections requiring antibiotic or antiviral treatment
  • Previous history of blood cancer or invasive non-breast cancer except curatively treated cancers with no recurrence for at least 3 years (including breast cancer for healthy participants)
  • Major surgery within 4 weeks prior to blood collection
  • Initiated new treatment line after disease progression at time of blood or tissue biopsy collection
  • Known severe coagulation or hematological disorder
  • Pregnancy
  • For metastatic breast cancer patients: histological confirmation of Triple Negative Breast Cancer (TNBC)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IEO

Milan, Italy, 20132

Actively Recruiting

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Research Team

L

Luca Mazzarella, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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