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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Italy
Istituti Clinici Scientifici Maugeri SpA
RECRUITING
Pavia
Time Frame
Start Date: 2022-12-01
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 80
Treatments
MBC
Patients diagnosed with metastatic breast cancer
EBC
Patients diagnosed with primary early-breast cancer candidate for surgery
HC
Control group of sex and age matched healthy volunteers, not affected by any neoplastic disease
Related Therapeutic Areas
Sponsors
Leads: Istituti Clinici Scientifici Maugeri SpA
Collaborators: Carlo Morasso

This content was sourced from clinicaltrials.gov