Background Individual differences in susceptibility to SARS-CoV-2 infection, symptomatology and clinical manifestation of COVID-19 have thus far been observed but little is known about the prognostic factors of young patients. Methods A retrospective observational study was conducted on 171 patients aged ≤ 65 years hospitalized in Alessandria’s Hospital from 1st March to 30th April 2020 with laboratory confirmed COVID-19. Epidemiological data, symptoms at onset, clinical manifestations, Charlson Comorbidity Index, laboratory parameters, radiological findings and complications were considered. Patients were divided into two groups on the basis of COVID-19 severity. Multivariable logistic regression analysis was used to establish factors associated with the development of a moderate or severe disease. Findings A total of 171 patients (89 with mild/moderate disease, 82 with severe/critical disease), of which 61% males and a mean age (± SD) of 53.6 (± 9.7) were included. The multivariable logistic model identified age (50–65 vs 18–49; OR = 3.23 CI95% 1.42–7.37), platelet count (per 100 units of increase OR = 0.61 CI95% 0.42–0.89), c-reactive protein (CPR) (per unit of increase OR = 1.12 CI95% 1.06–1.20) as risk factors for severe or critical disease. The multivariable logistic model showed a good discriminating capacity with a C-index value of 0.76. Interpretation Patients aged ≥ 50 years with low platelet count and high CRP are more likely to develop severe or critical illness. These findings might contribute to improved clinical management.

Pleural mesothelioma (PM) is an aggressive tumor with few therapeutic options. Although patients with epithelioid PM (ePM) survive longer than non-epithelioid PM (non-ePM), heterogeneity of tumor response in ePM is observed. The role of the tumor immune microenvironment (TIME) in the development and progression of PM is currently considered a promising biomarker. A few studies have used high-throughput technologies correlated with TIME evaluation and morphologic and clinical data. This study aimed to identify different morphological, immunohistochemical, and transcriptional profiles that could potentially predict the outcome. A retrospective multicenter cohort of 129 chemonaive PM patients was recruited. Tissue slides were reviewed by dedicated pathologists for histotype classification and immunophenotype of tumor-infiltrating lymphocytes (TILs) and lymphoid aggregates or tertiary lymphoid structures (TLS). ePM (n = 99) survivors were further classified into long (>36 months) or short (<12 months) survivors. RNAseq was performed on a subset of 69 samples. Distinct transcriptional profiling in long and short ePM survivors was found. An inflammatory background with a higher number of B lymphocytes and a prevalence of TLS formations were detected in long compared to short ePM survivors. These results suggest that B cell infiltration could be important in modulating disease aggressiveness, opening a pathway for novel immunotherapeutic approaches.

No abstract

In the health research system, multiple actors are confronted daily with the common goal of promoting scientific development in the clinical field. The Clinical Trial Center of the Alessandria Hospital has as its vision to become an attractive center for clinical research and for this reason has decided to design a Satisfaction Survey to be sent to the main intermediary with the bodies that promote research: the Contract Research Organizations (CRO). The Survey consists of two distinct questionnaires: one to be sent cyclically to CROs and one dedicated to monitors following a monitoring visit. REDCap was used to send the Surveys and collect and analyze the results; a web-based software already in use at the Hospital. The data collected will refer to three thematic areas: the role of the recipient within the CRO, relations with the Hospital, and the degree of general satisfaction. The process of sending and collecting data also has the purpose of retaining CROs and consolidating a communication network, as well as being a useful tool for the formulation of quality indicators.

No abstract

Objective: The aim is to evaluate the speed in the activation of Covid-19 clinical trials at SS. Antonio e Biagio e Cesare Arrigo Hospital of Alessandria during the pandemic. Methods: Data collection related to the activation and the conduction of clinical trials was managed using a database created through a web-based platform REDCap (Research Electronic Data Capture). Results: 32 studies were activated in the period between March 23 and July 31, 2020. An average time of 14 days elapsed between taking charge of the request and the issuance of the authorization act. Conclusions: During the emergency it was possible to activate the trials quickly thanks to fast-track procedures, optimizing COVID-19 clinical research.

Objective: to promote and enhance the research activity at the Public Hospital and the Local Health Authority in Alessandria, the translation of results into clinical practice, excellence and constant growth in the medical, health and administrative area, through the creation of research-oriented project groups.Methodology: the system development methodology refers to the Lean Thinking, and in particular to the X-Matrix, a framework in management studies to support the strategy definition and management process.Results: 14 project groups named “disease unit” were created, with own referents and components, planned and timed actions related to specific thematic areas. Members cooperated to increase scientific productivity, to promote the activation of clinical studies, the participation in funding national and European calls, the integration into international and European research networks and collaboration with universities, hospitals and IRCCS.Conclusions: the institution and coordination of the unit disease increased scientific production, supporting the collaboration and integration between the Public Hospital and the Local Health Authority with the University of Eastern Piedmont on the themes of research, innovation, experimentation and training, in relation to the way towards the IRCCS recognition.

The increasing complexity of clinical research makes it indispensable for an Institution that wants to conduct clinical trials to have an Organisational Structure and a dedicated multidisciplinary team. Since 2013, the public Hospital "SS Antonio and Biagio and C. Arrigo" of Alessandria (AO AL) has established a Clinical Trial Center (CTC), that has now become a centralized inter-company sector of the Research and Innovation Department. The CTC is part of the Research Infrastructure with its head office at AO AL and a further office at the Local Health Authority Territorial Hospital "S. Spirito" of Casale Monferrato (ASL AL). The CTC aims to design high standard clinical trials, ensuring better efficiency in their activation, management and data management according to the Good Clinical Practice (GCP) guidelines. Over the years, the CTC has grown and gained professional skills such as the Clinical Research Coordinator (CRC) and the Clinical Research Nurse (CRN), not yet officially recognized by the National Health System. These are skilled professional figures, that have been adequately trained even with post-graduate education through a 1st level Master in "Data Management and Coordination of Clinical Trials" which was activated by the University of Eastern Piedmont in collaboration with AO AL. The number and diversity of the activities carried out by CRCs and CRNs within the CTC has led them to develop a tool that strategically permits to recollect and record the time needed to perform these tasks with the aim of evaluating the different types of activities undertaken and assessing the needs of new staff. The organizational model adopted by the AO AL and the ASL AL through a centralized inter-company CTC represents a unique organizational model in the regional scenario and a peculiarity within the Public Health Authority not as yet recognized as Scientific Institutes for Research, Hospitalization and Healthcare.