Overview
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.
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)