Evaluation of See.d as an Automated Blood Sample Preparator for Multiple Liquid Biopsy Applications

Breast Cancer Clinical Trial

Official title:

Feasibility Evaluation of See.d Pre-Analytical Platform Performance: From Whole Blood to Plasma and SBS Slides for Liquid Biopsy Applications

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06097156
• Other study ID #: TET-22-001
• Status: Recruiting
• Start date: November 6, 2023
• Est. completion date: November 2024

Study information

• Verified date: December 2023
• Source: Tethis S.p.A.
• Contact: Luca Mazzarella, MD
• Phone: +39 0294375111
• Email: luca.mazzarella[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to evaluate the feasibility of using See.d instrument and SBS slides for preparation of plasma and cytological samples from whole blood.

Forty-five participants will be enrolled (20 healthy volunteers and 25 metastatic breast cancer patients) and each participant will be asked to provide a blood sample.

Description:

The goal of this study is the evaluation of a new instrument called See.d, to be used in conjunction with its accessories, Smart Bio Surface (SBS) slides, for preparation of cytological samples (seeded on SBS slides) and plasma from fresh whole blood (within 4-6 hours from collection).

Blood samples collected from healthy volunteers will be spiked-in with reference DNA and mock-CTC to mimic a patient sample in order to evaluate the instrument performance through the analysis of several parameters.

Blood samples from Metastatic Breast Cancer (MBC) patients will be processed with See.d instrument installed in a clinical context to perform a preliminary analytical characterization of either cell-free DNA (cfDNA) and Circulating Tumor Cells (CTC).

For its feasibility nature, no formal statistics has been planned for this study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• General (all participants)

• Participants is willing and able to give and sign a written informed consent

• Aged 18 or above

• Blood parameters if available (hematology: complete blood count, kidney and liver function, total protein and albumin, coagulation, etc)

• Specific for metastatic breast cancer patients

• Female for metastatic breast cancer patients, aged 18 or above

• Histological confirmation of breast cancer

• Presence of at least one non-bone metastasis

• Disease assessed to be in clinical or radiologic progression to the last line of treatment, as evaluated by the investigator and reported in the CaseReport Form

• The biopsy can be scheduled for <4 weeks after the date of blood withdrawal

• Blood sampling must be performed at least later than 7 days after the last biopsy or any other minor surgical procedure

• Specific for healthy participants

• Both sexes for healthy volunteers, aged 18 or above

• Healthy participants who visit the site for reason other than cancer diagnosis (including breast cancer).

Exclusion Criteria:

• Ongoing infections requiring antibiotic or antiviral treatment

• History of other malignancies other than breast cancer (for healthy participants also includes breast cancer).

• Undergone major surgery or treatment for breast cancer (including endocrine, targeted, radio- or chemotherapy) <4 weeks before enrolment

• Presence of known severe coagulation or haematological disorder

• Pregnancy

• For metastatic breast cancer patients: histological confirmation of a Triple Negative Breast Cancer (TNBC)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Healthy Participants

Locations

Country	Name	City	State
Italy	IEO	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Tethis S.p.A.

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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

Gennari A, Andre F, Barrios CH, Cortes J, de Azambuja E, DeMichele A, Dent R, Fenlon D, Gligorov J, Hurvitz SA, Im SA, Krug D, Kunz WG, Loi S, Penault-Llorca F, Ricke J, Robson M, Rugo HS, Saura C, Schmid P, Singer CF, Spanic T, Tolaney SM, Turner NC, Curigliano G, Loibl S, Paluch-Shimon S, Harbeck N; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. ESMO Clinical Practice Guideline for the diagnosis, staging and treatment of patients with metastatic breast cancer. Ann Oncol. 2021 Dec;32(12):1475-1495. doi: 10.1016/j.annonc.2021.09.019. Epub 2021 Oct 19. No abstract available. — View Citation

Ignatiadis M, Sledge GW, Jeffrey SS. Liquid biopsy enters the clinic - implementation issues and future challenges. Nat Rev Clin Oncol. 2021 May;18(5):297-312. doi: 10.1038/s41571-020-00457-x. Epub 2021 Jan 20. — View Citation

Krol I, Schwab FD, Carbone R, Ritter M, Picocci S, De Marni ML, Stepien G, Franchi GM, Zanardi A, Rissoglio MD, Covelli A, Guidi G, Scarinci D, Castro-Giner F, Mazzarella L, Doglioni C, Borghi F, Milani P, Kurzeder C, Weber WP, Aceto N. Detection of clustered circulating tumour cells in early breast cancer. Br J Cancer. 2021 Jul;125(1):23-27. doi: 10.1038/s41416-021-01327-8. Epub 2021 Mar 24. — 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

Turashvili G, Brogi E. Tumor Heterogeneity in Breast Cancer. Front Med (Lausanne). 2017 Dec 8;4:227. doi: 10.3389/fmed.2017.00227. eCollection 2017. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of White Blood Cells adhered on SBS slides	Evaluation of total adhered cell count on SBS slides	1 day (at the blood draw)
Primary	SBS slides stability	Evaluation of the area of adhered cell nuclei 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 using See.d SBS slides for subsequent analysis	Recovery of putative Circulating Tumor Cells (CTCs)	1 day (at the blood draw)
Primary	Feasibility of using See.d plasma for subsequent analysis	Detection of already known DNA mutations	1 day (at the blood draw)