Lido Di Camaiore

Researchers are conducting a large prospective, observational cohort study to assess the clinical impact of new monoclonal antibodies (MAB) in treating B-cell Non-Hodgkin Lymphoma (NHL) within Italian clinical practice. The study focuses on patients needing treatment for B-cell NHL, including those receiving first-line or relapsed/refractory therapy. The novel MAB being studied have received approval from the European Medicines Agency (EMA) since 2020 and are prescribed according to authorized marketing indications in Italy. Participants will receive novel MAB treatments either alone or in combination, prescribed based on EMA-approved indications since 2020. Patients will be grouped into cohorts according to the treatment indication, antibody type, and lymphoma subtype, with additional sub-cohorts created if necessary. This design allows analysis by indication, antibody type, subtype, and overall evaluation of the entire patient cohort. Throughout the study, researchers will collect clinical information to evaluate the use, feasibility, efficacy, and toxicity of these novel antibodies. Key outcomes measured over at least five years include 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 incidence of early and late adverse events. Participants will be closely monitored for both short- and long-term effects of the treatments.

Researchers are evaluating the activity and safety of combining platinum-pemetrexed based chemotherapy with Lorlatinib in adults with ALK positive Non-Small Cell Lung Cancer (NSCLC) who have extracranial disease progression while on Lorlatinib. This multicenter, phase II, single-arm study aims to understand how this treatment affects progression-free survival compared to historical data of chemotherapy after Lorlatinib. The treatment includes an induction phase of four cycles of platinum-pemetrexed chemotherapy plus Lorlatinib, where the choice of platinum drug (Carboplatin or Cisplatin) is made by the clinician. After this, patients who show response or stable disease on imaging will enter a maintenance phase, continuing with pemetrexed and Lorlatinib in 21-day cycles until disease progression, unacceptable side effects, death, or withdrawal from the study. Participants will undergo regular radiological assessments using CT and MRI scans to monitor disease status. Researchers will measure progression-free survival for up to 60 months. Throughout the study, safety and side effects will be closely monitored, and participants' organ functions will be assessed to ensure suitability for treatment.

Researchers are evaluating if combining atezolizumab with standard chemotherapy can improve treatment for patients with sensitive relapse Extensive-stage Small Cell Lung Cancer (ES-SCLC) after progression following first-line treatment. This phase II multicenter study aims to determine whether this combination increases overall survival and to identify any medical problems participants may experience. Sensitive relapse is defined as cancer returning or progressing at least 60 days after completing initial chemo-immunotherapy including PD-L1 inhibitors like atezolizumab or durvalumab. Participants will receive rechallenge chemotherapy consisting of carboplatin plus etoposide at doses chosen by the investigator along with atezolizumab 1200 mg intravenously on day 1 every 3 weeks. This induction phase lasts up to 4 cycles. After that, participants continue with maintenance atezolizumab every 3 weeks for up to 18 cycles or 1 year, unless disease progression, unacceptable toxicity, or other stopping criteria occur. The study treatment period can last up to 15 months. Radiological assessments with CT scans are done at 6 weeks, 12 weeks, and then every 12 weeks to monitor response. Participants attend clinic visits every 3 weeks for treatment and assessments. Researchers continuously monitor for side effects and safety throughout the study. The total study duration is up to 45 months, including about 24 months for enrollment, treatment up to 15 months, and 6 months of survival follow-up. The main outcome measured is overall survival through study completion, averaging 1 year.

Researchers are evaluating the clinical characteristics and procedural efficacy and safety of different permanent cardiac pacing implantation approaches in patients over 18 years old who need a pacemaker or intracardiac defibrillator. The study focuses on various pacing methods including right chamber endocardial pacing, epicardial pacing, cardiac resynchronization therapy (CRT), conduction system pacing (CSP), and leadless pacing. The study aims to understand how these methods affect patient survival and quality of life, as well as the potential benefits of non-fluoroscopic anatomical and electrophysiological systems during implantation. Participants will receive permanent cardiac pacing devices according to European Society of Cardiology guidelines. The pacing types studied include conventional right ventricular pacing, conduction system pacing (such as His bundle and left bundle branch area pacing), CRT involving biventricular or left ventricular pacing, epicardial pacing, and leadless pacing. The study will observe the safety and effectiveness of these modalities at 30 days, 6 months, and 12 months, considering factors like stable electrical parameters, absence of hospitalizations, and device-related complications. During the study, researchers will collect clinical and procedural data from patients who have undergone device implantation at participating centers over a 10-year period, with an equal follow-up duration. Assessments will include monitoring device function, hospitalizations for heart failure, all-cause mortality, heart failure occurrence, and arrhythmias. Safety evaluations will track procedural complications, infections, and need for re-intervention. This comprehensive data collection aims to improve understanding of pacing methods and their impact on patient outcomes.

Researchers are conducting the HEROS study, a multicenter observational and prospective research project in Italy, to investigate how HER2 mutations in advanced non-small cell lung cancer (NSCLC) are currently diagnosed and treated in real-world clinical practice. This study partners with the ATLAS project, which gathers data from 59 centers on oncogene alterations in newly diagnosed advanced NSCLC patients. The HEROS study will specifically focus on calculating the prevalence of HER2 mutations and studying approximately 100 HER2-mutated patients for further secondary and exploratory purposes. The study will enroll patients from September 2024 to September 2025, with follow-up lasting 12 months. A subset of 25 centers will also conduct prospective biomarker analysis using blood and tissue samples from primary tumors or metastatic sites, depending on tissue availability. All centers involved in this biomarker analysis are part of the ATLAS project. Patients will be grouped into cohorts based on their HER2 mutation status and tissue sample availability to fulfill the study objectives. Participants will be adults with confirmed advanced or metastatic NSCLC enrolled in the ATLAS project. Researchers will collect and analyze clinical data and biological samples to measure the prevalence of HER2 mutations over one year. The study involves ongoing monitoring and data collection through the ATLAS database and biomarker testing to better understand HER2 mutation incidence and therapeutic management, with the total participation duration including enrollment and 12 months of follow-up.

The PREgnancy and FERtility (PREFER) study is a comprehensive program designed to improve care and knowledge about fertility preservation and pregnancy issues in young women with breast cancer. It includes two separate studies: PREFER-FERTILITY, which focuses on fertility preservation strategies and their outcomes, and PREFER-PREGNANCY, which investigates pregnancy management and outcomes for breast cancer patients diagnosed during or after pregnancy. This program is conducted across multiple Italian institutions and aims to collect detailed data to better understand these important topics. PREFER-FERTILITY collects information on patients' preferences and choices regarding fertility preservation options available in Italy, as well as the success and safety of these methods, such as ovarian function recovery and post-treatment pregnancies. PREFER-PREGNANCY gathers data on the treatment of breast cancer diagnosed during pregnancy, obstetrical and pediatric care for children exposed to anticancer treatments in utero, and clinical outcomes for breast cancer survivors who become pregnant after treatment. Both studies together provide a broad view of fertility and pregnancy challenges in this patient population. Participants are monitored for up to 15 years, with outcomes including rates of interest and uptake of fertility preservation strategies, types of strategies offered by oncologists, reasons for refusal, types of anticancer therapies during pregnancy, pregnancy complications, adverse events, disease-free survival, and overall survival. Data collection includes long-term follow-up to assess safety and effectiveness, aiming to optimize future care for young breast cancer patients facing fertility and pregnancy decisions.

Researchers are studying extracorporeal blood purification therapies (EBPT) used in critically ill patients, especially those with acute kidney injury, sepsis, or systemic inflammatory response syndrome. The study aims to identify specific groups of patients who benefit most from different EBPT membranes, as previous trials have shown mixed results on long-term outcomes like mortality. Personalized approaches to EBPT, called precision medicine, are being explored to improve patient care and outcomes. Participants will receive EBPT using commercial membranes prescribed by their healthcare centers according to local practices and expertise. This observational study does not change treatment plans but records detailed treatment settings in a web-based registry. This platform, accessible also by smartphone or tablet, helps clinicians manage patients and provides real-time feedback, including clinical scoring and antibiotic adjustments. During the study, researchers will collect and analyze clinical and biochemical data entered into the registry by multiple centers. They will track patient characteristics, treatment details, and outcomes to find patterns indicating which patients respond best to EBPT. The main outcome measured is identifying the subgroup of critically ill patients who most benefit from EBPT within 10 days of starting treatment. This large database approach supports personalized treatment strategies and ongoing clinical monitoring.