Circulating Tumour Cells Characterization in Breast Cancer Patients
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-90
SponsorIstituti Clinici Scientifici Maugeri SpA
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Diagnosis of any neoplastic disease
Trial 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.
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Blood sample
DeviceFor each patient, a 15 ml EDTA blood sample will be collected at different time-points
Treatment groups
80 Participants
are divided into 3 treatment groupsGroup A: MBC1 intervention
Group B: EBC1 intervention
Group C: HC1 intervention
Trial outcomes
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.
Time frame
24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Istituti Clinici Scientifici Maugeri SpA
Lead sponsor
Carlo Morasso
Collaborator
Source ClinicalTrials.gov