Evaluating a new blood processing instrument for liquid biopsy applications
Feasibility Study Aiming at Pre-Analytical Standardization of Whole Blood Processing for Liquid Biopsy Applications
This study is testing a new blood processing tool to see how well it can prepare blood samples for liquid biopsies using samples from healthy volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tethis S.p.A. Industry-sponsored |
| Locations | 1 site (Milan) |
| Trial ID | NCT05942066 on ClinicalTrials.gov |
What this trial studies
This feasibility study aims to assess the performance of a new blood processing instrument called See.d, which prepares cytological samples and plasma from fresh whole blood. Blood samples will be collected from healthy volunteers to evaluate the instrument's effectiveness and explore the development of enhanced processing capabilities and analytical protocols for liquid biopsy applications. The study will enroll 200 participants, and no formal statistical analysis is planned due to its feasibility nature.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adults aged 18 or older who can provide informed consent.
Not a fit: Patients with ongoing infections, known hemostasis or coagulation disorders, or those who are pregnant may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for liquid biopsy applications, enhancing diagnostic capabilities.
How similar studies have performed: While this approach is exploratory, similar studies in liquid biopsy have shown promise in improving sample processing techniques.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan
- Ospedale San Raffaele — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Luca Santoleri, MD — Ospedale San Raffaele
- Study coordinator: Luca Santoleri
- Email: MEDICI.CDS@HSR.IT
- Phone: 02 2643 2340
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.