Circulating Tumour Cells Characterization in Breast Cancer Patients

NCT06048835 | Recruiting

• 1 other identifier: 2684
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Detect specific proteins on CTCs in breast cancer patients

  Clinical validation of a new technological device able to detect specific target surface proteins on CTCs in breast cancer patients, both non-metastatic and metastatic.

  24 months

Study Arms (3)

MBC

Patients diagnosed with metastatic breast cancer

Device: Blood sample

EBC

Patients diagnosed with primary early-breast cancer candidate for surgery

Device: Blood sample

HC

Control group of sex and age matched healthy volunteers, not affected by any neoplastic disease

Device: Blood sample

Interventions

Blood sample DEVICE

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

EBC; HC; MBC

Eligibility Criteria

• Age: 18 Years - 90 Years
• Gender Eligibility Details: Breast cancer is referred to women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study involves female patients with diagnosis of early-breast cancer candidate for surgery and female patients with diagnosis of metastatic breast cancer. A control group of sex and age matched healthy volunteers, not affected by any neoplastic disease will be enrolled too.

You may qualify if:

• 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.

You may not qualify if:

• Diagnosis of any neoplastic disease

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead
• Carlo Morasso: collaborator

Study Sites (1)

Istituti Clinici Scientifici Maugeri SpA

Pavia, Lombardy, 27100, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 21, 2023
• Study Start: December 1, 2022
• Primary Completion: September 30, 2025
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 23, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)