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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Healthy Participants, Breast Cancer

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Healthy donors<br>Participants who are in good health and without history of cancer disease | |
| Metastatic Breast Cancer patients<br>Metastatic breast cancer category is based on the definition of the European Society of Medical Oncology and is defined as disease spread to other parts of the body, such as bones, liver or lungs (also called stage IV). Tumours at distant sites are called metastases. | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Metastatic Patients, Liquid Biopsy, Whole Blood, Plasma, White Blood Cells, Pre-Analytical Standardization