Evaluating a new automated blood sample preparation method for liquid biopsies
Feasibility Evaluation of See.d Pre-Analytical Platform Performance: From Whole Blood to Plasma and SBS Slides for Liquid Biopsy Applications
This study is testing a new way to prepare blood samples for cancer testing to see if it works well for both healthy people and those with metastatic breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tethis S.p.A. Industry-sponsored |
| Locations | 1 site (Milan) |
| Trial ID | NCT06097156 on ClinicalTrials.gov |
What this trial studies
This study evaluates the See.d instrument and Smart Bio Surface (SBS) slides for preparing plasma and cytological samples from whole blood. It will enroll 45 participants, including 20 healthy volunteers and 25 metastatic breast cancer patients, who will provide blood samples. The samples from healthy volunteers will be spiked with reference DNA to mimic patient samples, while samples from breast cancer patients will be processed to analyze cell-free DNA and circulating tumor cells. The study aims to assess the feasibility of this new preparation method without formal statistical analysis.
Who should consider this trial
Good fit: Ideal candidates include females aged 18 or above with histologically confirmed metastatic breast cancer and clinical progression of disease.
Not a fit: Patients without metastatic breast cancer or those not meeting the specific inclusion criteria will not benefit from this study.
Why it matters
Potential benefit: If successful, this method could improve the efficiency and accuracy of liquid biopsies for cancer diagnosis and monitoring.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in the use of liquid biopsies for cancer diagnostics.
Eligibility criteria
Show full inclusion / exclusion 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 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)
Where this trial is running
Milan
- Ieo — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Luca Mazzarella, MD — IEO Hospital
- Study coordinator: Luca Mazzarella, MD
- Email: luca.mazzarella@ieo.it
- Phone: +39 0294375111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.