Faenza

This research focuses on men with prostate cancer who have previously participated in an enzalutamide clinical study sponsored by Astellas or Medivation. It aims to gather long-term safety information from participants who continue to benefit from enzalutamide treatment. This is a Phase 2 open-label extension study designed to monitor ongoing treatment effects after the initial study has completed its primary analysis or evaluation period. Participants will continue their previous treatment regimens, which may include enzalutamide taken orally once daily. Some may also receive abiraterone acetate with prednisone or leuprolide acetate depending on their prior study enrollment. Dose adjustments are allowed with medical monitor approval. The first visit of this study should occur within seven days of the last visit of the prior study unless treatment is temporarily paused. Participants are asked to return to their study site every 24 weeks for safety reviews, including adverse event monitoring and medication checks. At visits every 12 weeks, participants return unused study drugs and receive new supplies if needed. Safety data, including all adverse events and serious adverse events, are collected from consent until study completion, which may last up to 96 months. The study follows local standard care guidelines and includes a post-marketing phase in South Korea.

Hepatocellular carcinoma (HCC) is the fifth most common cancer worldwide and the third leading cause of cancer-related death. Most cases develop in a cirrhotic liver, where scarring makes treatment more difficult. This research aims to collect and analyze data from patients treated in everyday medical settings to understand how new combinations of immunotherapy drugs, like atezolizumab-bevacizumab and durvalumab-tremelimumab, work in real life. The study also seeks to find the best order of treatments and clinical markers that predict how well patients respond to these therapies. The study observes patients receiving frontline systemic treatments, including atezolizumab-bevacizumab or other immunotherapy combinations. It focuses on patients with advanced liver cancer who are not candidates for local treatments like surgery. While no specific interventions are assigned by the study, it collects data on treatment sequences and responses to these immunotherapies over time. Participants will be monitored from enrollment for up to three years to evaluate treatment safety and toxicity as first-line therapy. Researchers will gather clinical and laboratory data to identify markers predicting treatment outcomes and examine how factors like disease progression and second-line therapies impact survival. This long-term follow-up aims to provide real-world evidence to guide future treatment decisions for liver cancer patients.

Researchers are evaluating the effectiveness of a combination treatment involving adagrasib, pembrolizumab, and chemotherapy for patients with advanced non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation. This Phase 2 trial focuses on patients with PD-L1 tumor proportion score (TPS) of 1% or higher, but less than 50%, who have not received prior systemic therapy for advanced disease. The study aims to assess how well this combination works as a first treatment option for this patient group. Participants receive adagrasib as oral tablets twice daily at a dose of 400 mg. Pembrolizumab and chemotherapy drugs (pemetrexed and either cisplatin or carboplatin) are given by intravenous infusion once every three weeks. The study includes several groups based on prior treatments and PD-L1 levels, with some participants having previously completed induction chemotherapy. Treatments are administered according to these schedules and patient eligibility. During the study, researchers monitor participants for tumor response and progression-free survival over 30 months. They use standard criteria to measure tumor size changes and disease progression. Assessments include clinical evaluations and imaging to track response to treatment. Safety and tolerability are also monitored throughout the study period to understand the effects of the combination therapy on patients.

Researchers are conducting an Italian multicenter, observational, prospective study to gather information on patients with bone metastases. The study aims to establish a National Bone Metastasis Database by collecting detailed data from all patients with bone metastases referred to participating centers. This effort helps track and understand the condition better over a long period. Patients with bone metastases from solid tumors will be registered in a specially designed online database created for this study. Each enrolled patient will be entered into this database and followed over time until death or until follow-up is stopped for any other reason. This approach allows researchers to monitor the disease progression and treatment outcomes using a centralized digital system. Participants will provide informed consent to be part of the study. Their medical data, including diagnosis information, will be collected and stored in the database. This process includes ongoing monitoring and follow-up assessments as available during the study, which may last up to 15 years. The main outcome is the creation and maintenance of the comprehensive National Bone Metastasis Database to support research and patient care.

Primary biliary cholangitis (PBC) is a rare autoimmune liver disease that causes chronic inflammation of the bile ducts inside the liver, leading to progressive damage and possible liver failure if untreated. Most patients with PBC in Italy are diagnosed early and treated with ursodeoxycholic acid (UDCA), the only approved medication, but a significant number, especially younger patients, do not respond well to this treatment. This study aims to create a national database of PBC patients in Italy linked to biological sample storage to better understand the disease's biology, subtypes, and progression. Researchers will collect detailed clinical information and laboratory investigations from PBC patients across about 60 participating centers in Italy. Data will be recorded using electronic forms at the start and annually thereafter. Biological samples will also be collected to study patients' genetics, immune system, and molecular differences among clinical profiles. This infrastructure will support translational research and improve knowledge about why some patients do not benefit from UDCA and may need liver transplantation. Participants will provide clinical and laboratory data and biological samples over time. The study will measure patient phenotypes and sub-phenotypes linked to disease progression over a total duration of 10 years. This resource will aid researchers, clinicians, epidemiologists, and industry by offering valuable data for clinical trials, patient care, and new treatment development. The study also supports European initiatives on rare diseases by building a comprehensive Italian PBC patient database.

Primary sclerosing cholangitis (PSC) is a rare, chronic liver disease characterized by inflammation and scarring of the bile ducts, which can lead to liver failure and increased risk of colorectal and liver cancers. Both children and adults can be affected, and PSC significantly reduces life expectancy, with a median survival of 17 years after diagnosis. This research aims to create a national database in Italy to better understand the disease's incidence, prevalence, patient types, progression factors, and responses to new treatments, since current data in Italy are limited and likely underestimate the true burden of PSC. The study involves recruiting patients diagnosed with PSC to collect detailed clinical information, laboratory test results, and biological samples. Clinicians will enter this data into electronic case report forms at the start and then annually. The collected biological samples will help researchers explore important aspects of patients' biology related to PSC. This observational study does not involve experimental treatment but focuses on gathering comprehensive data to support future research and improve understanding of PSC. Participants will be involved for the overall study duration, which spans 10 years. During this time, researchers will assess clinical profiles, monitor disease progression, and identify patient subtypes at higher risk. The study will track safety and long-term effects of emerging therapies through ongoing data collection. The primary outcome is to identify and define distinct PSC patient phenotypes and sub-phenotypes linked to disease progression risks, helping guide future care and research.