Next-generation imaging (NGI), particularly with prostate-specific membrane antigen positron emission tomography (PSMA PET) tracers, enables earlier and more accurate detection of metastases. However, conventional imaging (CT and bone scan) remains more affordable and widely accessible and was the standard used in most pivotal trials that established current survival outcomes. As PSMA PET becomes more widely adopted, a stage migration effect is emerging. However, key uncertainties persist regarding the actual proportional employment of NGI in clinical practice, main indications for its use and the mid-term and long-term effects of an NGI-driven treatment pathway. Furthermore, when or whether CI alone might remain enough informative for the treatment decision-making is still unclear.

The European Registry of Next-Generation Imaging in Advanced Prostate Cancer is a non-profit, non-interventional, multi-centre, international, prospective, investigator-initiated registry that is intended to collect real-world data on how patients with prostate cancer at risk of harbouring metastasis (high-risk at initial diagnosis, or after primary treatment) are managed according to the type of imaging used for the systemic work-up. The registry is conducted in two phases: (1) cross-sectional analysis of imaging choices and their effect on clinical decision-making and (2) longitudinal follow-up evaluating survival outcomes such as progression-free survival (PFS), disease-specific survival (DSS) and skeletal-related events (SSEs). Statistical analyses will include descriptive analysis of demographic and clinical variables, comparative analysis between different imaging pathways, survival and prognostic analyses using Kaplan–Meier tests. The expected minimum sample size of the registry is 600 patients, and the planned follow-up duration is 24 months for the longitudinal follow-up.

The study protocol was approved by the ethics committee of Fundació Puigvert (#C2024/30), and ethics approval is required at all participating sites. All patients will provide written informed consent. The results will be disseminated widely and transparently to maximise their effect on clinical practice, research and patient care through peer-reviewed publications, presentations at international conferences as well as through patient advocacy groups and relevant patient websites.

NCT06866782.

Leishmaniases are a group of vector-borne diseases caused by parasites of the genus Leishmania, which are renowned for increasing global spread due to factors like climate change, globalisation, urbanisation and migration. Leishmaniasis is classified as a neglected tropical disease but is endemic in several areas of the Mediterranean Basin, including Italy, where Leishmania infantum is most involved as the parasite, phlebotomine sand fly as the vector and dog as the principal reservoir. Effective surveillance of communicable infectious diseases is a goal worldwide for organisations such as the WHO and for local and national governments but is an unfulfilled objective. Even in Italy and particularly in the region of Tuscany, despite mandatory reporting, significant gaps each year are identified between reported cases and hospital admissions. By estimating the underreporting of confirmed human leishmaniasis cases, this protocol aims to suggest actions to strengthen the current epidemiological surveillance system to enable timely and effective public health intervention in human and veterinary populations.

This retrospective multicentre study, conducted in the Central Tuscany Health District, the most populous area of the Tuscany region with approximately 1.6 million inhabitants, is based on the analysis of data collected from 2014 to 2024 using diagnostic laboratory, hospital and regional information system sources. The primary objective is to estimate the degree of underreporting of leishmaniasis in this area through the application of capture-recapture models. The secondary objective is to analyse the clinical and demographic characteristics of individuals diagnosed as confirmed leishmaniasis cases between January 2014 and December 2024, as well as to perform a geolocation analysis of the cases. The study includes the entire population, both adult and paediatric, of the Central Tuscany Health District who underwent laboratory testing for leishmaniasis (serological tests identifying the presence of antibodies; parasitological examination with evidence of amastigotes in aspirates, smears or biopsy sections; culture examination of aspirates, biopsies and/or peripheral blood positive for the presence of promastigotes; identification of Leishmania nucleic acid in aspirates, biopsies and/or peripheral blood samples via molecular diagnosis).

The study is being conducted in accordance with the protocol approved by the Ethics Committee of the Tuscany Region – Pediatrics Section, in November 2024. Ethics Committee opinion register number: 219/2024. Because the study uses only pseudonymised, routinely collected administrative and laboratory data with no direct patient contact or intervention, individual informed consent was not required, as confirmed by the Ethics Committee. Findings will be submitted to a peer-reviewed journal, presented at international conferences and presented at stakeholder workshops.

Real-world data and patient-reported outcomes in diabetes in Emilia–Romagna is a multi-centric observational cohort study aimed at improving diabetes care in the Emilia–Romagna region, by exploring trends and predictors of clinical and psychological parameters in a large population of people with diabetes, during and after the COVID-19 pandemic.

The study has a mixed retrospective/prospective design. The retrospective component involves computerised data linkage of administrative and clinical data from the local health authorities of Romagna and Reggio Emilia, and the University Hospital of Parma, covering a population of approximately 100 000 prevalent cases with diabetes, followed throughout the years 2019–2024. The selection of data items collected in the reference time frame is based on the International Consortium for Health Outcomes Measurement (ICHOM) standard set for diabetes, including clinical, lifestyle, social and healthcare service measurements. The prospective component includes primary data collection of indicators of psychological well-being through the WHO-5 Well-Being Index, diabetes distress using the Problem Areas In Diabetes-Short Form and depression through the Patient Health Questionnaire-9, measured at 0–6 months in an overall sample of 455 people with type 2 diabetes. Statistical analysis will include descriptive analysis and multivariate logistic regression using a two-step federated approach.

The study has obtained ethics approval from the Ethics Committee of Romagna and the Ethics Committee of Area Vasta Emilia Nord. The results of the study will be published in scientific journals to evaluate quality and outcomes of diabetes care across the region.

NCT06639100.

Infectious diseases are a major global health concern, responsible for significant morbidity and mortality. To advance the understanding and treatment of these diseases, biobanks and biorepositories play a crucial role in guaranteeing sample traceability through their entire life cycle (collection, acquisition and registration, processing, storage, distribution) and future analysis of clinical and biological data.

The INfectious DIsease REgistry BIObank (INDI-REBIO) is an observational, prospective, monocentric, open-ended registry with ad hoc procedures and a systematic collection of uniform clinical, laboratory, imaging and therapeutic data of patients with suspected or microbiologically documented bacterial, viral, fungal and parasitic infectious diseases from the IRCCS San Raffaele Hospital (Milan, Italy). The study aims to collect both uniform data and biological samples such as blood and other relevant specimens. The registry aims to include significant patient numbers across various conditions (among others: bloodstream infections, endovascular infections as infective endocarditis, central nervous system infections, bone and joint infections, multidrug-resistant organisms (MDROs) colonisation, sexually transmitted infections, HIV infection, emerging and re-emerging infectious diseases), enabling comprehensive research on disease evolution, treatment outcomes and the identification of biomarkers.

The study adheres to ethical principles outlined by the Helsinki Declaration and Good Clinical Practice guidelines. It has received ethical approval (Comitato Etico CET Lombardia 1, CET 138–2023) and is registered on clinicaltrials.gov (NCT06418048). Participants will provide informed consent and can withdraw at any time. The study results will be disseminated through major international conferences and submitted to peer-reviewed research journals.

ClinicalTrials.gov, NCT06418048.