There are about 21062 clinical studies being (or have been) conducted in Italy. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Blood recovery is a common procedure that limits patient exposure to allogeneic blood products. Blood recovery is usually performed during different types of surgery, including cardiac and vascular surgery, or liver transplantation. Basically, the process utilizes blood cell savers and cell separators and is finalized to auto-transfusion. In our hospital, the blood recovery is carried out with the CATSmart continuous-flow device (Fresenius Kabi AG, Bad Homburg, Germany) that warrants the removal of > 95% of heparin, potassium, free hemoglobin, and non-emulsifiable lipids. In liver transplantation (LT), before removing the organ from the donor, the blood is usually flushed out of the liver. Nonetheless, in some circumstances, donor blood cells may be transferred to recipients together with the solid organ during graft implantation. This is a feasibility study exploring RBC (red blood cell) concentrates obtained from the blood organ donor to support transfusion requirements in liver recipients. Donor RBC units are produced according to the quality standards recommended by the European Directorate for the Quality of Medicines & HealthCare of the Council of Europe, with equivalent content of Hb and residual leukocytes as standard RBC products.
The aim of the study is to evaluate changes in retinal function by means of electro-functional examinations of the retina and to associate them with any changes in chorioretinal vascular density occurring in the ipsilateral eye after carotid revascularization surgery.
The purpose of the study is to obtain and centralize data about cancer prevention strategies in women with a germline deleterious mutation in BRCA1-2 with or without a history of breast cancer in Italy
Daratumumab is a human first-in-class monoclonal antibody that targets a cluster of differentiation (CD) 38, a cell surface protein that is overexpressed on multiple myeloma (MM) cells, showing significant activity in relapsed/refractory disease. More recently, it was demonstrated that the addition of daratumumab to pre-autologous hematopoietic stem cell transplant (ASCT) induction regimens in newly diagnosed multiple myeloma increased the rate of complete responses and disease-free survival. However, in consideration of the expression of CD38 antigen also by stem cells, daratumumab could exert effects on their mobilization, collection, and engraftment. The primary objective of this retrospective/prospective observational study is to investigate the impact of adding daratumumab to standard induction regimens (VTD:bortezomib-thalidomide and dexamethasone, VD: bortezomib and dexamethasone) on stem cell mobilization in patients with newly diagnosed multiple myeloma (NDMM) who are candidates for ASCT.
A Study to evaluate the PK, PD, efficacy, and safety of Anifrolumab in children with moderate to severe active SLE
Improved standards of care and the regular early use of glucocorticoid treatment have changed the natural history of Duchenne muscular dystrophy (DMD), affecting both survival and time of loss of functional milestones. More recently, there has been increasing evidence of an additional benefit from new therapeutic approaches based on mechanisms targeting specific types of mutation, as Atarulen, authorised in the European Union as Translarna since 31 July 2014 to treat DMD boys with non sense mutations. As there is increasing evidence that specific groups of mutations may have different progression of the disease, it has become mandatory to obtain more detailed long-term information about the patterns of progression related to different genotypes. Natural history of DMD boys carrying deletions has been more studied and less is known about boys carrying small mutations that represent 20% of DMD patients. The aim of this project is to better define the natural history of these patients and to better understand the clinical response to mutation-specific therapies aimed at restoring dystrophin protein production.
On the basis of the now consolidated literature and clinical experience of focal therapies, the execution of partial prostatectomy/hemiprostatectomy with robot-assisted laparoscopic technique can be proposed in a well-selected cohort of patients. The hypothesis is that with this technique it is possible to achieve excellent levels of disease control, in terms of positive surgical margins (PSM) and biochemical recurrence of the disease (BCR), against a minimal impact as regards postoperative functional outcomes (continence and sexual power).
The goal of this observational study is to characterize the circulating leukocyte profile and the immune T cells distribution within the tumor in patients with malignant brain tumors and to correlate these findings with the oncological outcome. Participants will be subjected to blood sampling before surgery and for 12 months of follow-up. Additional sampling and analysis will be performed on tumor samples.
Triple-negative breast cancer (TNBC) is defined by the absence of estrogen receptor (ER), progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2) expression on cancer cells. TNBCs accounts for 15-20% of all breast cancers (BC).1 It is characterized by a worse prognosis, increased risk of metastasis to vital organs and a relative lack of therapeutic target if compared to other BC subtypes.2 Therefore, the identification of new molecular targets and therapeutic strategies is a critical need in both early and metastatic setting. TNBC appears to be more immunogenic compared to other BC6. Immunotherapy has recently changed the landscape of therapeutic options in TNBC. Recent clinical trials have shown a significant clinical benefit in patients with metastatic TNBC treated with a combination of chemotherapy and anti PD-1 agents.11-12-13-14-15 In particular, results from IMPASSION 130 trial showed a significant benefit in both progression free survival (PFS) and overall survival (OS) in PD-L1 positive (PD-L1+) patients treated with a combination of atezolizumab and nab-paclitaxel.20 However, about 70% of PD-L1+ patients has experienced a disease progression after one year and about 50% was alive at 2 year. Moreover, no difference in survival endpoint has been seen in PD-L1 negative (PD-L1-) population, with an increase of toxicity and costs related to the addition of a checkpoint-inhibitor. Therefore, the identification of novel biomarkers in addition to PD-L1 and the combination of several biomarkers in a profile with higher predictive capacity is considered an area of urgent clinical need. Some immune-related features that can be identified in tumor microenvironment have been demonstrated to be independent prognostic and predictive factors: TILs, PD-L1, CD73. 1. Tumour-infiltrating lymphocytes (TILs) control the clinical progression of various types of cancer7. Breast cancer with higher levels of infiltrating CD8+ cytotoxic T cells have been associated with better patient survival8. Moreover, high levels of stromal CD8+ TILs (sTILs) correlate with higher probability of pCR9. Not only quantitative, but also qualitative analysis of TILs is a promising research area. Some studies suggest that different subtypes of TILs may have an opposite role in tumor microenvironment allowing the induction of both immune activating (es. CD8+) or immune suppressive (es FOXP3+) environment8-9-10. 2. The interaction between programmed cell death protein 1 (PD-1) and its ligand (PD-L1) represents one of the principal mechanisms of immune escape and a therapeutic target for several malignancies13-14. PD-1/PD-L1 interaction attenuates lymphocyte activation and promotes T-regulatory cell development and function, allowing to terminate the immune response15. In breast cancer the prognostic role of PD-1/PD-L1 axis is still uncertain with limited and contrasting data. PD-L1 positivity (≥1%) on immune cells (IC) is the clinical most used threshold, according to the results of IMPASSION 130 trial.18-24 3. Recently, CD73 has been identified as a possible further molecular immunosuppressive target in triple negative breast cancer28. CD73 is expressed on the surface of tumoral cells, stromal cells and immunological cells. By increasing extracellular levels of adenosine monophosphate , CD73 suppresses immune responses. CD73 has been found to be overexpressed in several types of human cancers, and it has been associated with a poor prognosis29-30-31. Particularly Loi et al demonstrated that high CD73 expression is associated with poor prognosis in TNBC and to a low rate of pathological complete response32. We defined a tissue immune profile positive (TIP+) as the simultaneous presence of TILs≥50%, CD73≤40% and PD-L1≥1%. Any other combination was defined as TIP negative (TIP-) In conclusion, we will evaluate the association between TIP and clinical outcomes (ORR, PFS, OS).
Extracellular vesicles (EVs) are lipid bilayer-delimited particles, naturally released from the 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 EVs may have a prognostic and predictive value in breast cancer. Considering their presence in body fluids and their minimally invasive assessment through blood sampling, EVs could be liquid biopsy-derived biomarkers. Their quantification could be a complex challenge, requiring complicated and time-consuming pre-analytical procedures of EVs isolation. A new method for the detection of tumor-derived-EVs associated proteins is 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 EVs plasma levels in patients affected by BC, providing useful diagnostic and prognostic information about the efficacy of the neoadjuvant treatment.