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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05942066
• Other study ID #: TET-23-001
• Status: Recruiting
• Start date: October 9, 2023
• Est. completion date: July 2025

Study information

• Verified date: November 2023
• Source: Tethis S.p.A.
• Contact: Luca Santoleri
• Phone: 02 2643 2340
• Email: MEDICI.CDS[@]HSR.IT
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Tethis S.p.A.

Country where clinical trial is conducted

Italy, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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