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Recruiting NCT06048835

Circulating Tumour Cells Characterization in Breast Cancer Patients

Trial Parameters

Condition Breast Cancer
Sponsor Istituti Clinici Scientifici Maugeri SpA
Study Type OBSERVATIONAL
Phase N/A
Enrollment 80
Sex FEMALE
Min Age 18 Years
Max Age 90 Years
Start Date 2022-12-01
Completion 2025-09-30
Interventions
Blood sample

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

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