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

Inclusion criteria

• General (all participants)
• Participants is willing and able to give and sign a written informed consent
• Aged 18 or above
• 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
• The biopsy, when recommended by the oncologist, is scheduled within 4 weeks after the date of blood withdrawal
• Last biopsy or any other minor surgical procedure was perfomed at least 7 days before blood withdrawal
• Known Bilirubin level ≥ 2 mg/dL on a blood sample collected within 7 days from the enrolment. If unavailable, it is not necessary to assess bilirubin
• 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
• Previous history of a blood cancer or an invasive non-BC apart from cancers treated with curative intent at least 3 years previously with no recurrence since diagnosis with the exception of non-melanoma skin cancer. For healthy participants also includes breast cancer
• Undergone major surgery \< 4 weeks prior to the time of blood collection
• Initiated a new line of treatment after disease progression at the time of blood or tissue biopsy collection
• Presence of known severe coagulation or haematological disorder
• Pregnancy
• For metastatic breast cancer patients: histological confirmation of a Triple Negative Breast Cancer (TNBC)