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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy donors | Participants who are in good health and willing to provide a blood sample |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luca Santoleri | Contact | 02 2643 2340 | MEDICI.CDS@HSR.IT |
| Name | Affiliation | Role |
|---|---|---|
| Luca Santoleri, MD | Ospedale San Raffaele | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ospedale San Raffaele | Recruiting | Milan | 20132 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33811121 | Background | 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. | |
| 35154443 | 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. |
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This is a feasibility study without an individual participant data sharing plan
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| 34756687 | 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. |
| 29441349 | 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. |
| 35333365 | 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. |
| 22972811 | 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. |
| 33258744 | 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. |
| 32256286 | 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. |
| 16504283 | 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. |
| 20615202 | 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. |