Characterizing circulating tumor cells in breast cancer patients
Ultrasensitive BIOsensing Platform for Multiplex CELLular Protein PHEnotyping at Single-cell Level
This study is testing a new device to collect and analyze cancer cells from the blood of breast cancer patients to help tailor treatments for them.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Pavia, Lombardy) |
| Trial ID | NCT06048835 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a novel device for isolating and characterizing circulating tumor cells (CTCs) in breast cancer patients. It will involve consecutive patients diagnosed with various types of breast cancer, including metastatic and early-stage cases, as well as a control group of healthy volunteers. Blood samples will be collected at specific time points to analyze CTCs and gather clinical information, with the goal of improving patient stratification and personalized treatment approaches. The study is set to last for 24 months, starting from December 2022.
Who should consider this trial
Good fit: Ideal candidates include female patients diagnosed with metastatic breast cancer or early-stage breast cancer who are candidates for surgery.
Not a fit: Patients with any other neoplastic disease will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for early detection of metastasis in breast cancer patients, enhancing personalized treatment strategies.
How similar studies have performed: While there have been various approaches to CTC detection, this study's specific methodology and device development represent a novel approach in the field.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * female patients with diagnosis of metastatic breast cancer, confirmed by clinical practice staging exams. * female patients with biopsy-confirmed diagnosis of early-breast cancer candidate for primary surgery after multidisciplinary evaluation. * patients not affected by any neoplastic disease. Exclusion Criteria: * Diagnosis of any neoplastic disease
Where this trial is running
Pavia, Lombardy
- Istituti Clinici Scientifici Maugeri SpA — Pavia, Lombardy, Italy (Recruiting)
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.