Status:
RECRUITING
Evaluation of See.d as an Automated Blood Sample Preparator for Multiple Liquid Biopsy Applications
Lead Sponsor:
Tethis S.p.A.
Conditions:
Healthy Participants
Breast Cancer
Eligibility:
All Genders
18+ years
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 h...
Detailed 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 (seede...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 6 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT06097156
Start Date
November 6 2023
End Date
June 1 2025
Last Update
December 18 2024
Active Locations (1)
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1
IEO
Milan, Italy, 20132