NCT06097156 Evaluation of See.d as an Automated Blood Sample Preparator for Multiple Liquid Biopsy Applications
| NCT ID | NCT06097156 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tethis S.p.A. |
| Condition | Healthy Participants |
| Study Type | OBSERVATIONAL |
| Enrollment | 45 participants |
| Start Date | 2023-11-06 |
| Primary Completion | 2026-12 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
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 t