Publications by authors named "Cagnazzo C"

Originally established to evaluate the ethical aspects of clinical trials, Ethics Committees (ECs) are now requested to review different types of projects, including, among others, observational studies and disease registries. In Italy, clinical trials on medicinal products for human use and on medical devices are regulated by EU Regulation 536/2014, EU Regulation 2017/745, and 2017/746 while pharmacological observational studies are regulated by the Italian Medicines Agency guidelines of 2008 and by Ministerial Decree of November 30th, 2021. The other types of studies are not strictly regulated, causing discrepancies in their definition and assessment by the ECs, and slowdowns in the start of projects.

View Article and Find Full Text PDF

Background: The prognosis of patients with Relapsed/Refractory Osteosarcoma (R/R OS) remains dismal without an agreement on systemic therapy. The use of High-Dose Ifosfamide (14 g/sqm) with an external pump in outpatient setting (14-IFO) in R/R OS patients is limited. This study represents the first retrospective cohort analysis focused on evaluating the activity and toxicity of 14-IFO in this setting.

View Article and Find Full Text PDF

The consequences of the Italian privacy legislation, that represents a very restrictive implementation of the general European regulation on data protection, have mainly been felt at the level of observational research. In this field is not always possible to obtain the consent of subjects, and as for retrospective studies, it is not currently clear which is the correct regulatory procedure to follow. This uncertainty in the law's implementation has given way to multiple interpretations, making it difficult to obtain a homogeneous path in Italy.

View Article and Find Full Text PDF

Children and adolescents affected by brain tumors are at risk for neuropsychological sequelae that need to be evaluated in order to plan adequate rehabilitation programs, and to support their development and recovery. This work aims to describe an innovative prospective observational study protocol for the early evaluation and monitoring over time of neuropsychological outcomes in this pediatric population. Pediatric patients aged 3-17 with a brain tumor diagnosis will be assessed through the use of a battery of Italian standardized neuropsychological tests, with good psychometric properties and age-appropiate, at three different time points of their clinical course: at diagnosis and before surgery (T0), after surgical removal and before the start of potential adjuvant therapies (T1), and at the one-year follow-up after potential adjuvant therapies (T2).

View Article and Find Full Text PDF

Background: In the last decade many clinical research centers in Italy have increasingly implemented and improved their quality standards and effectiveness of processes through the adoption of a quality management system also according to the certification ISO 9001:2015.

Objective: The aim of this project is to evaluate expected benefits and barriers of ISO 9001 certification for a Clinical Trial Center.

Material And Methods: On April 2021, the Italian Group of Data Manager and Clinical Research Coordinator spread an anonymous online survey to healthcare professionals operating in clinical research and quality management systems at research sites.

View Article and Find Full Text PDF

Background: The 2022 World Health Organization (WHO) classification redefines the concept of gray zone lymphoma (GZL), restricting it in practice to cases of mediastinal/thymic origin (mediastinal gray zone lymphoma, MGZL) with overlapping features between primary mediastinal B-cell lymphoma (PMBCL) and classical Hodgkin lymphoma (CHL). Cases with histological characteristics of GZL but occurring without mediastinal involvement are better classified as diffuse large B-cell lymphoma, not otherwise specified (DLBCL NOS), with few exceptions.

Procedure: We collected clinical and pathological data about all Italian pediatric patients diagnosed with GZL over a 20-year period.

View Article and Find Full Text PDF

Observational trials are crucial to assess the generalizability in the real world of evidence deriving from registration studies. Despite the unquestionable importance of this type of studies, Italian researchers have had to face many obstacles over the years, mainly due to ambiguous definitions and to a complex but at the same time incomplete legislation. The regulatory adjustments to the European Regulation 536/2014 have further complicated the operating and operational framework, making observational research a real "Cinderella" of the Italian system.

View Article and Find Full Text PDF

Introduction: In Europe, despite recent advances in clinical development, most of the drugs currently used to treat childhood cancers are adult medicines, prescribed outside of the authorized indication. In this context, a monocentric retrospective cohort analysis was conducted, evaluating pediatric, adolescent, and young adult patients affected by onco-hematologic disease, treated with targeted therapies used off-label or as compassionate use.

Methods: The analysis was conducted on 45 patients aged less than or equal to 30 years with cancer, having received at least one targeted therapy prescribed as off-label or compassionate use at a large Italian pediatric center between January 1, 2016 and June 30, 2021.

View Article and Find Full Text PDF
Article Synopsis
  • Fluoropyrimidines (FP) are a key chemotherapy for colorectal cancer (CRC) but can lead to underreported heart damage, known as FP-induced cardiotoxicity (FIC).
  • A study monitored 129 CRC patients for FIC, finding that 15.5% experienced symptoms like chest pain and dyspnoea, although most had no significant ECG changes.
  • No specific risk factors were strongly linked to FIC, aside from alcohol consumption in females, and no effective circulating biomarkers were identified for predicting FIC, emphasizing the need for careful symptom monitoring during FP treatment.
View Article and Find Full Text PDF

Objectives: To assess whether the use of the revised Cochrane risk of bias tool for randomized trials (RoB2) in systematic reviews (SRs) adheres to RoB2 guidance.

Methods: We searched MEDLINE, Embase, Cochrane Library from 2019 to May 2021 to identify SRs using RoB2. We analyzed methods and results sections to see whether risk of bias was assessed at outcome measure level and applied to primary outcomes of the SR as per RoB2 guidance.

View Article and Find Full Text PDF

The European regulation 536/2014, unapplied for several years due to the inoperability of the European Portal, represented an epochal turning point in the legislation concerning pharmacological clinical trials. Although, unlike the directive, it could be directly applied without national transpositions, in Italy this has not been possible and for three months now we have been witnessing a haemorrhage of guidelines/operational proposals/decrees that to date do not make us ready to fully operate according to the new rules. Il regolamento europeo 536/20141, in vigore dal 16 giugno 2014 e rimasto per diversi anni non applicato per un ritardo nella messa in funzione del portale unico europeo, ha rappresentato una svolta epocale nella normativa inerente le sperimentazioni cliniche con farmaco.

View Article and Find Full Text PDF

Purpose: This is a multicenter, single-arm phase II trial evaluating the efficacy and safety of an immune-sensitizing strategy with temozolomide priming followed by a combination of low-dose ipilimumab and nivolumab in patients with microsatellite-stable (MSS) and O-methylguanine-DNA methyltransferase (MGMT)-silenced metastatic colorectal cancer (mCRC).

Patients And Methods: Patients with pretreated mCRC were centrally prescreened for MSS status and MGMT silencing (ie, lack of MGMT expression by immunohistochemistry plus methylation by pyrosequencing). Eligible patients received two priming cycles of oral temozolomide 150 mg/sqm once daily, days 1-5, once every 4 weeks (first treatment part) followed, in absence of progression, by its combination with ipilimumab 1 mg/kg once every 8 weeks and nivolumab 480 mg once every 4 weeks (second treatment part).

View Article and Find Full Text PDF
Article Synopsis
  • Lateral flow immunoassays (LFIA) are used for quick testing of infectious diseases like COVID-19, with their accuracy heavily depending on the quality of immunoreagents.
  • Researchers developed two types of LFIA devices using broad-selective bacterial proteins (SpA and SpG) linked to gold nanoparticles to enhance sensitivity and versatility in detecting SARS-CoV-2 antibodies.
  • The SpA-based LFIA showed a higher diagnostic sensitivity (89.9%) and selectivity (91.7%) in testing human serum samples compared to the SpG-based assay and could also detect antibodies in pets of COVID-19 patients.
View Article and Find Full Text PDF

Background: The burnout phenomenon has been extensively investigated among health care professionals, particularly focusing on physicians and nurses. However, literature concerning burnout in clinical research is poor and often neglects the other professional categories involved.

Methods: In March 2019, all members of Italian Group of Clinical Research Coordinator were invited to participate to a web survey, consisting of three sections: general information and workload; Maslach Burnout Inventory (MBI) test; subjective perception of oneself's work stress and possible causes.

View Article and Find Full Text PDF

A rapid test for detecting total immunoglobulins directed towards the nucleocapsid protein (N) of severe acute syndrome coronavirus 2 (SARS CoV-2) was developed, based on a multi-target lateral flow immunoassay comprising two test lines. Both test lines bound to several classes of immunoglobulins (G, M, and A). Specific anti-SARS immunoglobulins were revealed by a colorimetric probe formed by N and gold nanoparticles.

View Article and Find Full Text PDF

The coronavirus disease 2019 (COVID-19) pandemic has stressed the importance of health research as never before. In the specific domain of clinical research, the effort to rapidly find responses to health challenges and therapeutic hypotheses has highlighted the need for efficient, timely, ethically correct research. The guidelines published by the Agenzia Italiana del Farmaco have shown that some useful changes are feasible: simple and rapid methods have been implemented to conduct clinical research in the emergency conditions of the pandemic, maintaining high levels of quality.

View Article and Find Full Text PDF

: New trends are emerging in clinical research, such as patient empowerment and an active role in influencing health and research ethics. Patients' involvement is considered pivotal by stakeholders and institutions because they can channel the voice of those they represent, empowering their starring role in the different research activities.: To obtain an overview of the real involvement of Italian patient associations in clinical research.

View Article and Find Full Text PDF

The law of March 2019 established the municipal epidemiological report to make easier the rapid and lowresource monitoring of the exposed population. Environmental observatory active in Trino since 2014 has equipped this tool and making the first evalution of the risk with census sections from 1970 to 2018. The result highlighted that overall mortality (for total gender) show a decreasing trend while for oncological diseases the results are more difficult to interpret especially in areas close to former industrial sites or contaminated sites.

View Article and Find Full Text PDF

The CoViD-19 pandemic has pointed out the the need for an efficient, timely, ethically correct clinical research, in order to find rapid and reliable responses to health challenges. The guidelines published by the Agenzia Italiana del Farmaco during the pandemic have shown that some useful changes for simplifying and speeding-up clinical research in Italy are feasible, while maintaining high levels of quality. In this perspective, a reflection is a must: perhaps we are ready to detach ourselves from that image of a slow and bureaucratic country now widespread in Europe.

View Article and Find Full Text PDF

Over the past few years, clinical research has developed considerably. To achieve adequate quality standards in its design and management, it was necessary to set up dedicated and qualified multi-professional teams, made up not only of medical personnel. This has led to the emergence of new professional roles, such as that of the research nurse (clinical research nurse, study nurse or clinical trial nurse).

View Article and Find Full Text PDF

Background: There is plenty of evidence for a relation between certain environmental pollutants and ecological damage. Landfills, especially if uncontrolled and located near human settlements, may cause an increase in cancer incidence and in various diseases.

Methods: The area of study is represented by the cities of Ghemme (population 6,139) and Cavaglio (population 2,216), in the province of Novara, northern Italy.

View Article and Find Full Text PDF

Background: An accurate risk-stratification is key to optimize the benefit-to-risk ratio of palliative treatment in advanced biliary cancer. We aimed at assessing the impact of the prognostic nutritional index (PNI) on survival and treatment response in advanced biliary cancer (ABC) receiving first-line chemotherapy.

Methods: Medical records of ABC treated with standard chemotherapy at the Modena Cancer Centre were retrospectively reviewed for variables deemed of potential interest, including the PNI.

View Article and Find Full Text PDF

Background: The Agenzia Italiana del Farmaco (AIFA) Determination 809/2015 sets all the requirements that clinical units and laboratories must meet in order to conduct phase I studies. Requirements include buildings, equipment, personnel, emergency management, as well as quality requirements defined in a set of standard operating procedures.

Methods: In September 2018, the Italian Association of Medical Oncology working group, Clinical Research Coordinator, created an anonymous survey addressed to 51 medical directors of oncologic/hematologic clinical phase I units and all medical directors of generic and transversal units located in Italy and listed at the AIFA website.

View Article and Find Full Text PDF