RecruitingNCT06048835

Circulating Tumour Cells Characterization in Breast Cancer Patients

Ultrasensitive BIOsensing Platform for Multiplex CELLular Protein PHEnotyping at Single-cell Level


Sponsor

Istituti Clinici Scientifici Maugeri SpA

Enrollment

80 participants

Start Date

Dec 1, 2022

Study Type

OBSERVATIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 90 Years

Inclusion Criteria3

  • 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 Criteria1

  • Diagnosis of any neoplastic disease

Interventions

DEVICEBlood sample

For each patient, a 15 ml EDTA blood sample will be collected at different time-points


Locations(1)

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, Italy

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NCT06048835


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