Feasibility Study Aiming at Pre-Analytical Standardization of Whole Blood Processing for Liquid Biopsy Applications
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Healthy donors Participants who are in good health and willing to provide a blood sample |
Outcome Measures
Primary Outcome Measures
- SBS slides stability [1 day (at the blood draw)]
Evaluation of the area of adhered cell nuclei on SBS slides
- Reagents stability [1 day (at the blood draw)]
Evaluation of total adhered cell count on SBS slides
- cfDNA quality control [1 day (at the blood draw)]
Evaluation of the ratio between cfDNA and genomic contaminant DNA
- Feasibility of staining on slides produced by See.d [1 day (at the blood draw)]
Qualitative assessment of staining positivity
- Feasibility of using See.d SBS slides for subsequent analysis [1 day (at the blood draw)]
Recovery of mock-Circulating Tumor Cells (CTCs)
- Feasibility of using See.d plasma for subsequent analysis [1 day (at the blood draw)]
Recovery of spiked reference DNA
Eligibility Criteria
Criteria
Inclusion Criteria:
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Participants are willing and able to give and sign a written informed consent
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Aged 18 or above
Exclusion Criteria:
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Ongoing infections requiring antibiotic or antiviral treatment
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Known hemostasis/coagulation disorder
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Known Pregnancy
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Tethis S.p.A.
Investigators
- Principal Investigator: Luca Santoleri, MD, Ospedale San Raffaele
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
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- 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.
- 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.
- 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.
- 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.
- TET-23-001