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

NCT05942066 | Recruiting

• 1 other identifier: TET-23-001
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Keywords

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

Outcome Measures

Primary Outcomes (6)

• SBS slides stability

  Evaluation of the area of adhered cell nuclei on SBS slides

  1 day (at the blood draw)

• Reagents stability

  Evaluation of total adhered cell count on SBS slides

  1 day (at the blood draw)

• cfDNA quality control

  Evaluation of the ratio between cfDNA and genomic contaminant DNA

  1 day (at the blood draw)

• Feasibility of staining on slides produced by See.d

  Qualitative assessment of staining positivity

  1 day (at the blood draw)

• Feasibility of using See.d SBS slides for subsequent analysis

  Recovery of mock-Circulating Tumor Cells (CTCs)

  1 day (at the blood draw)

• Feasibility of using See.d plasma for subsequent analysis

  Recovery of spiked reference DNA

  1 day (at the blood draw)

Study Arms (1)

Healthy donors

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Blood samples to be used in this clinical study will be collected from healthy volunteers, already willing to become blood donors and, for this reason, already going to be subjected to a venipuncture and a blood draw to evaluate their eligibility to blood donation

You may qualify if:

• Participants are willing and able to give and sign a written informed consent
• Aged 18 or above

You may not qualify if:

• Ongoing infections requiring antibiotic or antiviral treatment
• Known hemostasis/coagulation disorder
• Known Pregnancy

Sponsors & Collaborators

• Tethis S.p.A.: lead

Study Sites (1)

Ospedale San Raffaele

Milan, 20132, Italy

RECRUITING

Related Publications (10)

• Alix-Panabieres C, Pantel K. Liquid Biopsy: From Discovery to Clinical Application. Cancer Discov. 2021 Apr;11(4):858-873. doi: 10.1158/2159-8290.CD-20-1311.

  PMID: 33811121 BACKGROUND

• Xie S, Wang Y, Gong Z, Li Y, Yang W, Liu G, Li J, Hu X, Wang Y, Tong Y, Yuan P, Si Y, Kang Y, Mao Y, Qi X, Liu Y, Ou J, Li Z, Pan X, Lv Z, Kaji K, Guo L, Lu R. Liquid Biopsy and Tissue Biopsy Comparison with Digital PCR and IHC/FISH for HER2 Amplification Detection in Breast Cancer Patients. J Cancer. 2022 Jan 1;13(3):744-751. doi: 10.7150/jca.66567. eCollection 2022.

  PMID: 35154443 BACKGROUND

• Seale KN, Tkaczuk KHR. Circulating Biomarkers in Breast Cancer. Clin Breast Cancer. 2022 Apr;22(3):e319-e331. doi: 10.1016/j.clbc.2021.09.006. Epub 2021 Sep 22.

  PMID: 34756687 BACKGROUND

• Hench IB, Hench J, Tolnay M. Liquid Biopsy in Clinical Management of Breast, Lung, and Colorectal Cancer. Front Med (Lausanne). 2018 Jan 30;5:9. doi: 10.3389/fmed.2018.00009. eCollection 2018.

  PMID: 29441349 BACKGROUND

• Ho TH, Bissell MCS, Kerlikowske K, Hubbard RA, Sprague BL, Lee CI, Tice JA, Tosteson ANA, Miglioretti DL. Cumulative Probability of False-Positive Results After 10 Years of Screening With Digital Breast Tomosynthesis vs Digital Mammography. JAMA Netw Open. 2022 Mar 1;5(3):e222440. doi: 10.1001/jamanetworkopen.2022.2440.

  PMID: 35333365 BACKGROUND

• Hofvind S, Ponti A, Patnick J, Ascunce N, Njor S, Broeders M, Giordano L, Frigerio A, Tornberg S; EUNICE Project and Euroscreen Working Groups; Van Hal G, Martens P, Majek O, Danes J, von Euler-Chelpin M, Aasmaa A, Anttila A, Becker N, Pentek Z, Budai A, Madai S, Fitzpatrick P, Mooney T, Zappa M, Ventura L, Scharpantgen A, Hofvind S, Seroczynski P, Morais A, Rodrigues V, Bento MJ, Gomes de Carvalho J, Natal C, Prieto M, Sanchez-Contador Escudero C, Zubizarreta Alberti R, Fernandez Llanes SB, Ascunce N, Ederra Sanza M, Sarriugarte Irigoien G, Salas Trejo D, Ibanez Cabanell J, Wiege M, Ohlsson G, Tornberg S, Korzeniewska M, de Wolf C, Fracheboud J, Patnick J, Lancucki L, Ducarroz S, Suonio E. False-positive results in mammographic screening for breast cancer in Europe: a literature review and survey of service screening programmes. J Med Screen. 2012;19 Suppl 1:57-66. doi: 10.1258/jms.2012.012083.

  PMID: 22972811 BACKGROUND

• Durand MA, Friedewald SM, Plecha DM, Copit DS, Barke LD, Rose SL, Hayes MK, Greer LN, Dabbous FM, Conant EF. False-Negative Rates of Breast Cancer Screening with and without Digital Breast Tomosynthesis. Radiology. 2021 Feb;298(2):296-305. doi: 10.1148/radiol.2020202858. Epub 2020 Dec 1.

  PMID: 33258744 BACKGROUND

• Alavi N, Khan SH, Saadia A, Naeem T. Challenges in Preanalytical Phase of Laboratory Medicine: Rate of Blood Sample Nonconformity in a Tertiary Care Hospital. EJIFCC. 2020 Mar 20;31(1):21-27. eCollection 2020 Mar.

  PMID: 32256286 BACKGROUND

• Carbone R, Marangi I, Zanardi A, Giorgetti L, Chierici E, Berlanda G, Podesta A, Fiorentini F, Bongiorno G, Piseri P, Pelicci PG, Milani P. Biocompatibility of cluster-assembled nanostructured TiO2 with primary and cancer cells. Biomaterials. 2006 Jun;27(17):3221-9. doi: 10.1016/j.biomaterials.2006.01.056. Epub 2006 Feb 28.

  PMID: 16504283 BACKGROUND

• Zanardi A, Bandiera D, Bertolini F, Corsini CA, Gregato G, Milani P, Barborini E, Carbone R. Miniaturized FISH for screening of onco-hematological malignancies. Biotechniques. 2010 Jul;49(1):497-504. doi: 10.2144/000113445.

  PMID: 20615202 BACKGROUND

Study Officials

• Luca Santoleri, MD

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luca Santoleri

CONTACT

02 2643 2340; MEDICI.CDS@HSR.IT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 12, 2023
• Study Start: October 9, 2023
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)