Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06048835 |
| Other study ID # |
2684 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2022 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
May 2024 |
| Source |
Istituti Clinici Scientifici Maugeri SpA |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
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).
