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
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
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Lombardy
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Pavia, Lombardy, Italy, 27100
- Recruiting
- Istituti Clinici Scientifici Maugeri SpA
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Contact:
- Fabio Corsi, Professor
- Phone Number: 0382592272
- Email: fabio.corsi@icsmaugeri.it
-
Contact:
- Carlo Morasso, PhD
- Email: carlo.morasso@icsmaugeri.it
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
MBC
Patients diagnosed with metastatic breast cancer
|
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
|
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
|
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
Time Frame: 24 months
|
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.
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24 months
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2684
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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