Evaluation of the Quality of Care in the Emergency Department by Studying the Appropriateness of Hospitalizations: Validation of an Algorithm Based on Computerized Hospital Databases

The aim of this study is to develop, study and validate a rigorous and sustainable method for assessing the clinical appropriateness of the decision taken in the Emergency Department to admit or not to admit patients.

Start Date01 Jun 2025

Sponsor / Collaborator

Istituto di Ricerche Farmacologiche Mario Negri

NCT06797609

/ Not yet recruitingNot ApplicableIIT

Comparing the Performance of Serum Creatinine and Cystatin C-based GFR Estimations in Predicting Directly Measured GFR in Patients With or Without Nephrotic Syndrome

This observational study relates to subjects with primary membranous nephropathy enrolled in the ongoing PEPTIDE, MONET, and ORION clinical trials performed and coordinated by IRFMN (NCT04095156, NCT04893096, and NCT05050214 respectively) to assess the efficacy of anti-CD20 or anti-CD38 monoclonal antibodies (rituximab and obinutuzumab) or anti-CD38 monoclonal antibody (felzartamab) therapy in inducing remission of NS during 1-year follow-up.
Serum samples for measurement of Cystatin C (Cys-C), a low-molecular-weight protein, will be identified among those of the patients with NS who provided consent to store their samples at the Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò", Ranica (BG) in the certified biobank UNI EN ISO 9001:2015; certification n° 6121 - Centro di Risorse Biologiche Mario Negri - Biobanca Malattie Rare e Malattie Renali (CRB).
Measured GFR by plasma clearance of iohexol, as well as serum Cr or CKD EPI values in addition to the hematochemical and urinary parameters, are already available because measured during the studies in which the subjects were enrolled.
Serum samples will be tested by Laboratorio Analisi Chimico-Cliniche Area Specialistica del Settore Autoimmunità ASST Papa Giovanni XXIII, Bergamo.

Start Date01 May 2025

Sponsor / Collaborator

Istituto di Ricerche Farmacologiche Mario Negri

NCT06841887

/ Not yet recruitingNot ApplicableIIT

Unlock the Power of Resona 9 Ultrasound Machine: an Observational Study to Set-up and Test New Advanced Vascular Imaging Protocols

This is a single-center observational study aimed at setting up and testing new ultrasound vascular imaging protocols, conducted exclusively for research purposes. The study will perform US examinations in 60 subjects. The subjects enrolled in the study will be examined the first time and will then provide consent to be examined again in the future if needed.
The primary aim of this study is to set-up and test new advanced US protocol for the arm and cerebral blood vessels
The secondary objectives will be:
* Define ranges of normality/reference values of US-based parameters to be compared with pathological values.
* Evaluate the repeatability and reproducibility of the acquired US measurements.
* Evaluate the correlation between age and the acquired US measurements.
* Evaluate the correlation between gender and the acquired US measurements.

Start Date01 Apr 2025

Sponsor / Collaborator

Istituto di Ricerche Farmacologiche Mario Negri

100 Clinical Results associated with Istituto di Ricerche Farmacologiche Mario Negri

0 Patents (Medical) associated with Istituto di Ricerche Farmacologiche Mario Negri

11,758

Literatures (Medical) associated with Istituto di Ricerche Farmacologiche Mario Negri

21 Apr 2025·Cancer Research

Abstract 4548: The association between tissue genomic alterations and ctDNA shedding in non small cell lung cancer

Author: Wu, Sulin ; Pezeshk, Apameh ; Cameron, Robert ; Bestvina, Christine ; Garassino, Marina ; Abodunrin, Faith ; Esposito, Alessandra ; Torri, Valter ; Di Lello, Anna

AbstractIntroduction:Tumor burden, stage and metastatic extent are associated with the presence of circulating tumor DNA (ctDNA). However, the association between genomic alterations and the presence of ctDNA remains unclear.Methods:We retrospectively analyzed patients with non-small cell lung cancer (NSCLC) with available Next-Generation Sequencing (NGS) analysis on both tissue and blood treated at the University of Chicago. NGS on tissue biopsies was conducted using the internal Oncoplus assay (168 genes). NGS on blood samples was conducted using the Guardant360 assay. Plasma ctDNA concentration was measured by the Variant Allele Frequency (VAF). Spearman rank correlation coefficient was used to assess the relationship between increasing number of mutations and VAF. Wilcoxon rank-sum test was used to compare the distribution of VAF between subgroups.Results:A total of 221 patients were identified. Adenocarcinoma was the predominant histological subtype, accounting for 89.6% (n=199) of cases. The cohort was predominantly Caucasian (55.4%) and female (66.2%). The median age at diagnosis was 65 years. At the time of index liquid biopsy, 85.1% of patients had metastatic disease. Among the 221 patients, 129 (58.6%) harbored actionable mutations, with EGFR exon 19 or 21 mutations being the most prevalent (n=80, 36.2%). This study found a weak but significant association between VAF and mutation count in the tissue biopsy: for total mutations including both significant alterations and variants of unknown significance (r = 0.146, p=0.032) and for significant mutations only (r = 0.160, p=0.018). These associations were stronger in the KRAS G12C mutated sub-cohort for both total (r=0.471, p=0.036) and significant mutations (r=0.573, p=0.008). Significantly higher ctDNA VAF was observed in TP53 (p=0.006) and STK11 (p=0.05) mutant tumors.Conclusions:Our results showed a correlation between increasing number of alterations and ctDNA shedding. The association was stronger for KRAS G12C mutated tumors. The relationship between genetic changes and ctDNA release is supported by the increased ctDNA VAF seen in TP53 and STK11 mutant tumors.Citation Format:Robert Cameron, Anna Di Lello, Faith Abodunrin, Sulin Wu, Alessandra Esposito, Apameh Pezeshk, Valter Torri, Christine Bestvina, Marina Garassino. The association between tissue genomic alterations and ctDNA shedding in non small cell lung cancer [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 4548.

21 Apr 2025·Cancer Research

Abstract 2566: Dissecting PDAC cell-microenvironment interplay in liver metastasis by single cell analysis

Author: Bolis, Marco ; Fioravanti, Claudia ; Belotti, Dorina ; Resovi, Andrea ; Craparotta, Ilaria ; Taraboletti, Giulia ; Sangalli, Fabio ; Di Leva, Federica ; Vallerga, Arianna ; Garattini, Giulia ; Grasselli, Chiara ; Giavazzi, Raffaella

AbstractPancreatic ductal adenocarcinoma (PDAC) is one of the most lethal tumors. Because most PDAC patients are diagnosed with an already advanced and metastatic stage of the disease, only 15% are suitable for surgical intervention. Thus, an improved understanding of the metastatic mechanism is critical to improve the outcome of these patients. The most common target for PDAC metastasis is the liver. Outgrowth of metastases requires acquisition of tumor genetic alterations in conjunction with alterations in the pancreas and liver microenvironment. The aim of the study was to investigate the role of the tumor microenvironment and the molecular alterations in tumor and stroma cells leading to PDAC liver metastasis formation. To this purpose a metastatic cell variant was established from the FC1199 pancreatic cancer cell line, derived from tumors arisen in LSL-KrasG12D/+;LSL-Trp53R172H/+;Pdx-1-Cre mice and growing orthotopically in C57BL/6 mice. The FC199LV metastatic variant was obtained by successive rounds of in vivo selection of cells implanted in the pancreas, isolated from liver metastases and re-implanted in the pancreas for a total of 5 rounds. IHC and in vivo MicroCT analysis of livers at different time points after tumor cell injection highlighted the presence of metastases only in mice transplanted with FC1199LV. Single cell RNA-sequencing analysis of dissociated primary tumors and livers of mice transplanted with FC1199 and FC1199LV highlighted differences in the microenvironmental transcription profile between the two tumor variants. The spontaneous metastatic model of PDAC is an important tool to study the interplay between tumor and stroma in PDAC metastatic process and to identify a tumor and tumor microenvironment gene expression signature associated with PDAC liver metastasis. Supported by AIRC IG 2019 ID23443Citation Format:Claudia Fioravanti, Arianna Vallerga, Giulia Garattini, Ilaria Craparotta, Federica Di Leva, Chiara Grasselli, Fabio Sangalli, Andrea Resovi, Raffaella Giavazzi, Marco Bolis, Giulia Taraboletti, Dorina Belotti. Dissecting PDAC cell-microenvironment interplay in liver metastasis by single cell analysis [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 2566.

01 Mar 2025·STAR Protocols

Protocol for interpretable and context-specific single-cell-informed deconvolution of bulk RNA-seq data

Article

Author: Cippà, Pietro ; Bolis, Marco ; Ruinelli, Lorenzo ; Legouis, David ; Mangili, Francesca ; Azzimonti, Laura ; Malpetti, Daniele ; Rinaldi, Anna

Single-cell sequencing provides rich information; however, its clinical use is limited due to high costs and complex data output. Here, we present a protocol for extracting single-cell-related information from bulk RNA-sequencing (RNA-seq) data using the pathway-level information extractor (PLIER) algorithm. We describe the steps for extracting single-cell signatures from literature, training a PLIER model based on single-cell signatures (named CLIER), and applying it to a new dataset. This produces latent variables that are interpretable in the context of specific single-cell biology. For complete details on the use and execution of this protocol, please refer to Legouis et al.,¹ where this approach is used within the renal context.

100 Deals associated with Istituto di Ricerche Farmacologiche Mario Negri

100 Translational Medicine associated with Istituto di Ricerche Farmacologiche Mario Negri

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The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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Drug(Targets)	Indications	Global Highest Phase

Ortataxel ( Tubulin )	Glioblastoma More	Phase 2
IDN 5738 ( P-gp )	Neoplasms More	Preclinical
Empagliflozin ( SGLT2 )	Obesity More	Discontinued
GS-701644 ( KDM5 )	Breast Cancer More	Pending

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