Breast Cancer Clinical Trial
Official title:
Characterization of Extracellular Vesicles in Breast Cancer Patients' Plasma by Single Molecule Detection Array (SiMoA) Digital ELISA
NCT number | NCT05798338 |
Other study ID # | 2490 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | December 1, 2020 |
Est. completion date | September 30, 2024 |
Extracellular vesicles (EVs) are lipid bilayer-delimited particles, naturally released from cells and mediators of intercellular cross-talk. In breast cancer (BC), EVs seem to be involved in the tumor microenvironment's shaping, in cancer cells invasion and in the set-up of metastasis. Clinical studies have provided initial evidence that these vesicles may have a prognostic and predictive value in breast cancer. Considering their ubiquitous presence in body fluids and their minimally invasive assessment through blood sampling, EVs could have a potential as liquid biopsy-derived biomarkers. Their quantification though is a complex task requiring complicated and time-consuming pre-analytical procedures of EVs isolation. This protocol want to develop a new method for the detection of tumor-derived-EVs associated proteins, based on the use of Single Molecule Array (SiMoA), a digital ELISA technology able to detect and quantify extremely low concentrations of target proteins or particles. The aim of this study is to evaluate how this new technology can allow the quantification of EVs plasma levels in patients affected by BC, providing useful diagnostic and prognostic information.
Status | Recruiting |
Enrollment | 105 |
Est. completion date | September 30, 2024 |
Est. primary completion date | September 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Signing of a specific informed consent for participation to the study - Female sex Population 1: - Diagnosis of early breast cancer; - Indication for surgery after multidisciplinary discussion. Population 2: - Patients having a negative mammography or breast ultrasound within 12 months from the study enrollment. Population 3: - Diagnosis of metastatic breast cancer confirmed by cytological/histological examination or by imaging; - Indication to chemotherapy. Exclusion Criteria: Population 1: - Presence of distant metastases - Synchronous presence of a different tumor - Indication to neoadjuvant chemotherapy Population 2: - Diagnosis of breast cancer - Synchronous presence of a different tumor or chronic disease Population 3: - Patients who are unfit for systemic chemotherapy treatment |
Country | Name | City | State |
---|---|---|---|
Italy | Istituti Clinici Scientifici Maugeri SpA | Pavia | Lombardia |
Lead Sponsor | Collaborator |
---|---|
Istituti Clinici Scientifici Maugeri SpA |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | EVs levels in early BC | Determination of plasma EVs levels in patients with EBC by SIMOA digital ELISA and evaluation of the difference of their concentration compared to healthy controls | 36 months | |
Primary | EVs levels in metastatic BC | Determination of plasma EVs levels in patients with first diagnosis of metastatic BC by SIMOA digital ELISA and evaluation of the difference of their concentration compared to healthy controls | 36 months | |
Secondary | EVs levels after surgery | Determination of plasma EVs levels in patients with early BC one month after surgery and comparison with pre-surgery EVs levels in order to evaluate any qualitative of quantitative modifications in circulating EVs | 36 months | |
Secondary | EVs levels after chemotherapy treatment | Determination of plasma EVs levels in patients with first diagnosis of metastatic BC after 4 months of systemic therapy and comparison with pre-therapy EV's plasma levels | 36 months |
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