Circulating Tumour Cells Characterization in Breast Cancer Patients (BioCellPhe)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Blood sample

Detailed Description

This is an experimental, prospective and monocentric study. This study involves consecutive patients with diagnosis of breast cancer (BC), including early breast cancer and metastatic breast cancer patients, referring to the Breast Unit and to the Oncology Department at Istituti Clinici Scientifici Maugeri, Pavia (Italy).

Patients diagnosed with different histological types of breast cancer will be enrolled in the study: luminal BC, HER2-enriched BC, triple-negative BC.

The study duration is 24 months, starting from December 2022 to December 2024.

The patients will be divided into three groups, as follows:

• Population 1: patients diagnosed with metastatic breast cancer.
• Population 2: patients diagnosed with primary early-breast cancer candidate for surgery.
• Population 3: a control group of sex and age matched healthy volunteers, not affected by any neoplastic disease.

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

• Population 1: before starting a potential chemotherapy treatment.
• Population 2: before undergoing surgical procedure.
• Population 3: at the first useful moment. The blood samples will be collected at the Maugeri Institute and CTCs will be isolated within 48 hours to validate the device.

For each patient, the following clinico-anamnestic information will be collected: age, histological tumour information at diagnosis (tumour subtype, grading, receptors' status, Ki-67 value), histological metastases information, clinical stage (clinical TNM), type of surgery, pathological staging after surgery (pTNM).

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

Study Locations

• Italy
  • Lombardy
    • Pavia, Lombardy, Italy, 27100
      • Recruiting
      • Istituti Clinici Scientifici Maugeri SpA
      • Contact: Fabio Corsi, Professor; Phone Number: 0382592272; Email: fabio.corsi@icsmaugeri.it
      • Contact: Carlo Morasso, PhD; Email: carlo.morasso@icsmaugeri.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MBC; Patients diagnosed with metastatic breast cancer	Device: Blood sample; For each patient, a 15 ml EDTA blood sample will be collected at different time-points
EBC; Patients diagnosed with primary early-breast cancer candidate for surgery	Device: Blood sample; For each patient, a 15 ml EDTA blood sample will be collected at different time-points
HC; Control group of sex and age matched healthy volunteers, not affected by any neoplastic disease	Device: Blood sample; For each patient, a 15 ml EDTA blood sample will be collected at different time-points

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Istituti Clinici Scientifici Maugeri SpA
• Collaborators: Carlo Morasso

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): September 30, 2025
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: September 15, 2023
• First Submitted That Met QC Criteria: September 15, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): February 23, 2026
• Last Update Submitted That Met QC Criteria: February 20, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Blood Specimen Collection
• Other Study ID Numbers: 2684

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No