Lido Di Camaiore

Researchers are conducting a large prospective, observational cohort study to evaluate the clinical impact of new Monoclonal Antibodies MAB in patients with B-cell Non-Hodgkin Lymphoma NHL treated in Italian clinical practice. The study focuses on collecting information about the use, feasibility, effectiveness, and both short- and long-term side effects of novel MABs that have been approved by the European Medicines Agency since 2020 and prescribed according to authorized indications in Italy. Participants will be divided into groups based on treatment indication, antibody type, and lymphoma subtype to allow detailed analysis. The study observes patients with B-cell NHL who have received at least one dose of a novel MAB either alone or in combination, as authorized for use in Italy. Both patients receiving first-line treatment and those with relapsed or refractory disease are included. Various cohorts and sub-cohorts will be analyzed to understand outcomes by indication, antibody type, and histological subtype, providing a comprehensive overview of these treatments in real-life settings. Participants will be followed for at least five years to assess outcomes such as overall response rate, complete response rate, progression-free survival, overall survival, event-free survival, time to next treatment, non-relapse mortality, duration of response, and the incidence of early and late adverse events. Clinical data collection will include treatment details, safety monitoring, and long-term follow-up to evaluate both effectiveness and toxicity. The study spans several years, allowing researchers to capture extensive real-world evidence on novel MAB use in B-cell NHL.

Researchers are evaluating the activity and safety of combining platinum-pemetrexed based chemotherapy with Lorlatinib in patients who have ALK positive Non-Small Cell Lung Cancer NSCLC that has progressed only outside the brain while on Lorlatinib treatment. This phase II, multicenter, single-arm study focuses on patients with extracranial progression despite Lorlatinib, aiming to understand how this combination may affect progression and survival. Treatment begins with an induction phase of four cycles using Lorlatinib plus either Carboplatin or Cisplatin and Pemetrexed chemotherapy. After this, patients who show disease response or stability based on imaging scans enter a maintenance phase where they receive pemetrexed and Lorlatinib every 21 days. This maintenance continues until disease progression, unacceptable side effects, death, or withdrawal from the study. Participants will undergo regular assessments including CT and MRI scans to measure tumor response and monitor for progression. Researchers will evaluate progression-free survival as the primary outcome, along with intracranial progression-free survival, overall survival, and safety over up to 60 months. The study includes monitoring organ functions and treatment tolerability throughout the induction and maintenance phases, with continuous follow-up until the study ends or participants leave.

Researchers are evaluating if a combination of atezolizumab and standard chemotherapy can improve treatment outcomes for patients with sensitive relapse Extensive-stage Small Cell Lung Cancer ES-SCLC who have progressed after first-line treatment with platinum-etoposide chemotherapy plus PD-L1 inhibitors like atezolizumab or durvalumab. This phase II trial is designed to find out if continuing PD-L1 inhibition along with rechallenge chemotherapy increases overall survival and to monitor medical problems participants may experience. Eligible patients receive induction treatment with atezolizumab 1200 mg given intravenously on day 1 every 3 weeks along with carboplatin and etoposide chemotherapy for up to 4 cycles. After induction, patients continue maintenance therapy with atezolizumab every 3 weeks for up to 18 cycles or one year. Treatment continues until disease progression, unacceptable side effects, patient choice, or loss of clinical benefit. The study spans an expected 45 months, including 24 months for recruitment, 15 months maximum treatment duration, and up to 6 months of follow-up. Participants visit the clinic every 3 weeks for treatment, checkups, and tests. Radiological assessments using CT scans are done at 6 weeks, 12 weeks, and then every 12 weeks to check treatment response. Researchers continuously monitor safety and adverse events during treatment. The primary outcome is overall survival over about one year, with additional measures including progression-free survival and the frequency of adverse events. Participants are closely observed throughout the study to evaluate treatment effects and safety.

Researchers are evaluating the clinical characteristics and procedural outcomes of patients receiving permanent cardiac pacing to treat various heart rhythm disorders. This observational study compares the effectiveness and safety of different device implantation methods used in routine clinical practice, including the contribution of advanced non-fluoroscopic anatomical and electrophysiological mapping systems. The study focuses on patients over 18 years old who require a pacemaker or intracardiac defibrillator implant following European Society of Cardiology guidelines. The study includes several types of cardiac pacing approaches conventional right ventricular pacing, conduction system pacing such as His bundle or left bundle branch area pacing, cardiac resynchronization therapy CRT with biventricular or left ventricular pacing, epicardial pacing often done during cardiac surgery, and leadless pacing via a percutaneous femoral vein approach. Each method involves implantation of a device connected to cardiac leads positioned in specific heart locations, with vascular access through veins like the cephalic, axillary, or subclavian. Electrical parameters such as pacing threshold and sensing are measured to ensure device stability before final placement. Participants will be followed for up to 120 months with clinical and procedural data collected, including assessments of device efficacy and safety at 30 days, 6 months, and 12 months. Outcome measures include stable electrical device performance, absence of cardiovascular hospitalizations or death, and monitoring for heart failure or arrhythmia events. The study also tracks procedural times, radiation exposure, and complications such as infections or lead dislocations. This long-term observation aims to understand the benefits and risks of various pacing strategies in real-world settings.

Researchers are conducting the HEROS study, a multi-center observational and prospective study in Italy, to investigate the current diagnostic and treatment approaches for HER2-mutated advanced non-small cell lung cancer NSCLC. This study works with the ATLAS project, which collects data from over 59 centers on newly diagnosed advanced NSCLC patients, to understand how common HER2 mutations are and how they are managed in routine clinical practice. Patients enrolled in the ATLAS project from September 2024 to September 2025 will be included to study the prevalence of HER2 mutations. Approximately 100 patients with HER2 mutations will be closely observed for secondary and exploratory objectives. Additionally, a subset of 25 centers will collect blood and tissue samples from available tumor sites to perform biomarker analyses, further exploring the biological characteristics of these cancers. Participants will be followed for 12 months after enrollment to track clinical information and outcomes. Data will be gathered from medical records and biomarker samples when available. The main measure of interest is the prevalence of HER2 mutations over one year. This observational study does not involve any investigational treatments, and participants will continue their usual care while contributing data to help improve understanding of HER2-mutated NSCLC.

Researchers are conducting the PREgnancy and FERtility PREFER study to improve care and understanding of fertility preservation and pregnancy issues in young women with breast cancer. This comprehensive program includes two parts one focusing on fertility preservation choices and outcomes, and the other on managing breast cancer diagnosed during pregnancy and the health of children born after cancer treatment exposure. The study collects data over a long time to better understand these important topics. The PREFER study gathers information on fertility preservation strategies available in Italy, including patients preferences, the techniques used, and their success and safety. It also tracks breast cancer cases diagnosed during pregnancy or soon after, monitoring pregnancy management, child health after exposure to cancer treatments in the womb, and outcomes for survivors who become pregnant later. The program is carried out across multiple Italian centers under a research group. Participants provide data through medical records and follow-up over many years. Researchers measure how many patients choose fertility preservation, the types of treatments given during pregnancy, pregnancy complications, survival rates, ovarian function recovery, number of eggs preserved, and pregnancies achieved after treatment. They also evaluate hormone changes during chemotherapy and the health of children born to affected mothers. The study continues for up to 15 years to gather long-term safety and outcome information.

Researchers are investigating the use of extracorporeal blood purification therapies EBPT in critically ill patients, especially those with acute kidney injury and multiorgan failure. EBPT is commonly used in critical care to remove inflammatory substances from the blood, aiming to improve organ function. However, previous clinical trials have not consistently shown benefits on long-term outcomes like 28-day or hospital mortality. This study aims to identify specific groups of patients who might benefit most from different EBPT membranes by collecting detailed clinical data. This observational study involves critically ill patients receiving various EBPT treatments for kidney support or immune system modulation, using commercial membranes as prescribed by their healthcare providers. Treatments include continuous renal replacement therapy, intermittent hemodialysis, hybrid therapies, and immunomodulation through special membranes that adsorb endotoxins or cytokines. Each center records detailed treatment settings and patient information via a web-based registry accessible on smartphones and tablets, which also provides helpful clinical tools for managing patient care. Participants will be observed throughout their EBPT treatment, with researchers gathering data on clinical and biochemical changes over time, including scoring systems and other patient characteristics. The main outcome is to identify which patient subpopulations benefit most from EBPT, measured 10 days after treatment starts. The registry allows centers to monitor their own results in real time and supports personalized treatment approaches. The study is ongoing and aims to improve understanding of how to tailor EBPT to individual patient needs while enhancing clinical practice through shared data.