NCT06048835 Circulating Tumour Cells Characterization in Breast Cancer Patients
| NCT ID | NCT06048835 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2022-12-01 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
In the current scenario, a reliable liquid biopsy method for predicting outcomes in solid tumors, especially among breast cancer patients, is lacking. Circulating Tumor Cells (CTCs) serve as crucial indicators of metastasis, and their early detection could significantly enhance patient stratification and facilitate the customization of personalized treatments. However, detecting CTCs in breast cancer patients presents complexities due to their substantial phenotypic heterogeneity and typically low concentration. Numerous approaches have been developed for CTC detection. Nonetheless, the currently available technologies remain intricate, time-consuming, and costly. The BioCellPhe Project is dedicated to the development of a novel device capable of isolating and characterizing individual CTCs. This innovative device relies on the identification of specific cell membrane proteins with remarkable precision, achieved through the application of novel orthogonal techniques. On one hand, engineered bacteria are utilized to precisely bind to membrane proteins of interest on CTCs. On the other hand, Surface Enhanced Raman Spectroscopy (SERS) is employed for the detection of individual molecules. Specifically, the BioCellPhe Project focuses on comprehensively studying CTCs in breast cancer patients, encompassing both metastatic and non-metastatic cases.
Eligibility 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
Frequently Asked Questions
Who can join the NCT06048835 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 90 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06048835 currently recruiting?
Yes, NCT06048835 is actively recruiting participants. Visit ClinicalTrials.gov or contact Istituti Clinici Scientifici Maugeri SpA to inquire about joining.
Where is the NCT06048835 trial being conducted?
This trial is being conducted at Pavia, Italy.
Who is sponsoring the NCT06048835 clinical trial?
NCT06048835 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The trial plans to enroll 80 participants.
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