RecruitingNCT06097156

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

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

Sponsor

Tethis S.p.A.

Enrollment

45 participants

Start Date

Nov 6, 2023

Study Type

OBSERVATIONAL

Conditions

Breast Cancer Healthy Participants

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria14

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 Criteria7

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)