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Trial Title:
Evaluation of See.d as an Automated Blood Sample Preparator for Multiple Liquid Biopsy Applications
NCT ID:
NCT06097156
Condition:
Healthy Participants
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Metastatic Patients
Liquid Biopsy
Whole Blood
Plasma
White Blood Cells
Pre-Analytical Standardization
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
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.
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 (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.
Criteria for eligibility:
Study pop:
Participants will be selected from among the people who visit the Breast department
Sampling method:
Probability Sample
Criteria:
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
IEO
Address:
City:
Milano
Zip:
20132
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Luca Mazzarella, MD
Phone:
+39 0294375111
Email:
luca.mazzarella@ieo.it
Start date:
November 6, 2023
Completion date:
November 2024
Lead sponsor:
Agency:
Tethis S.p.A.
Agency class:
Industry
Source:
Tethis S.p.A.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06097156
