Potenza

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 how well elacestrant works compared to standard endocrine therapy in adults with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer who are at high risk of the cancer returning. This is a Phase 3 global, multicenter, randomized, open-label study focusing on participants who have had early invasive breast cancer removed and meet specific receptor and risk criteria. The study aims to understand which treatment better prevents invasive breast cancer over up to five years. Participants will receive either elacestrant or one of several standard endocrine therapies, including anastrozole, letrozole, exemestane, or tamoxifen, all given as oral tablets. Treatments will be administered according to the study plan, with careful monitoring throughout the trial. The study includes adults who have already received between 24 and 60 months of prior endocrine therapy, with or without certain inhibitors, and who have completed or stopped these treatments as required. During the study, participants will be monitored for invasive breast cancer-free survival for up to five years. Researchers will perform regular assessments to track treatment effects, side effects, and cancer recurrence. The study also includes safety monitoring and may involve additional tests or evaluations as needed to ensure participant well-being throughout the trial.

This research aims to evaluate how well guselkumab works in improving symptoms of psoriatic arthritis, an inflammatory joint disease affecting people with psoriasis, a skin condition that causes red, scaly patches. The study uses musculoskeletal ultrasound (MSUS) to assess treatment effects in a real-world clinical setting, focusing on participants with active psoriatic arthritis based on specific clinical and imaging criteria. Participants will start guselkumab treatment as part of their standard clinical care either at enrollment or within two weeks after the initial visit. Eligible participants are either biologic-naïve or have previously used only one biologic disease-modifying antirheumatic drug (bDMARD) or apremilast/deucravacitinib. The study includes detailed ultrasound assessments of joint inflammation and enthesitis (inflammation where tendons or ligaments attach to bone) before starting guselkumab. Throughout the study, researchers will monitor changes in joint inflammation using ultrasound scores at baseline and week 12, and evaluate disease activity using standardized disease activity indices at week 24. Participants will undergo clinical assessments, imaging, and laboratory tests related to psoriatic arthritis activity. The goal is to measure how guselkumab affects inflammation and disease activity over time in a real-world patient population.

Researchers are studying patients with early to locally advanced stages (I-III) of non-small cell lung cancer (NSCLC) to better understand how diagnosis and treatments are managed in real-world settings. Because patients with these stages of NSCLC can vary widely, there is no single standard treatment plan, and practices differ by country and medical center. This study looks closely at how surgery, chemotherapy, and radiotherapy are timed and combined for these patients without interfering with their treatment. This is a non-interventional, retrospective observational study analyzing medical records of patients with stage I-III NSCLC who received curative surgery or radiotherapy between January 2018 and June 2019. Researchers will examine diagnostic and treatment paths, focusing on the use and timing of therapies. The study does not involve new treatments or interventions but reviews past patient data to gather insights. Participants' medical records from January 2018 to January 2021 will be reviewed to assess treatment approaches, discussions in multidisciplinary teams, healthcare resource use, and direct medical costs related to NSCLC care. The study involves collecting data from available charts and follow-up information to understand treatment patterns and outcomes better. No active treatment or patient visits are required as this study relies on existing data.

Researchers are evaluating whether adding axitinib to nivolumab maintenance therapy after induction with nivolumab plus ipilimumab can improve treatment response in patients with metastatic renal cell carcinoma (mRCC). This phase II, open-label trial involves patients who completed induction therapy without achieving complete response or progressive disease. The goal is to increase the rate of partial responses from about 30% to 50%, based on results from previous trials. Participants are randomly assigned in a 1:1 ratio to receive either axitinib plus nivolumab or nivolumab alone. Axitinib is given at a standard dose of 5 mg twice daily, and nivolumab is administered intravenously at 480 mg every four weeks. Treatment continues until disease progression, unacceptable side effects, patient choice, or physician decision. The study plans to enroll 118 patients, with 59 in each treatment arm. During the trial, patients will undergo regular assessments including tumor measurements following RECIST criteria, laboratory tests, and evaluations of organ function and performance status. Researchers will monitor treatment efficacy by tracking the time until disease progression or death. Safety and tolerability will be closely observed, and patients must agree to contraception measures if applicable. The study aims to provide detailed information on the benefits and risks of adding axitinib to nivolumab maintenance therapy in mRCC.

Researchers are evaluating Trastuzumab deruxtecan (T-DXd) in adult patients with unresectable or metastatic HER2-low expressing breast cancer. This non-interventional study aims to assess the effectiveness of T-DXd, patients' demographic and clinical characteristics, treatment patterns, tolerability, management of adverse drug reactions, and patient experience. The study also collects data on conventional chemotherapy treatments in a disease registry to better understand treatment outcomes in this population. Participants will receive treatment with Trastuzumab deruxtecan or conventional chemotherapy drugs such as capecitabine, eribulin, gemcitabine, paclitaxel, or nab-paclitaxel according to the Summary of Product Characteristics and routine clinical practice. No study drug will be administered by the researchers, as treatments follow physicians' standard care decisions. This approach allows observation of real-world treatment use and outcomes. During the study, patients' treatment timelines and responses will be followed, focusing on the time to next treatment up to 31 months. Researchers will monitor tolerability, adverse drug reactions, and patient-reported experiences. Data collection includes clinical and demographic information, treatment patterns, and outcomes to provide a comprehensive understanding of T-DXd and conventional chemotherapy use in this patient group.

Researchers are investigating the evolution of neoadjuvant treatment for early breast cancer, focusing on patients with HER2-positive and Triple Negative tumors. The study aims to determine the percentage of these patients who received neoadjuvant therapy over the past five years, regardless of molecular subtype. Secondary goals include analyzing treatment choices, tumor characteristics, radiological responses, surgical procedures, adjuvant therapies, eligibility criteria changes, pathological complete response, disease-free survival, and overall survival according to molecular subtype and initial staging. This retrospective multicenter study reviews clinical practices in Italian oncology centers from 2016 to 2021. It includes patients diagnosed with early-stage breast cancer (stages I-III) who underwent neoadjuvant treatment. The study collects data on tumor subtype, treatment regimens, imaging methods such as breast MRI, ultrasound, mammography, and surgical treatments to understand therapeutic approaches and outcomes. Participants undergo data collection from medical records regarding tumor pathology, treatment responses, and survival outcomes over five years. Researchers measure the percentage of HER2-positive and Triple Negative tumors treated neoadjuvantly and perform descriptive analyses on treatment patterns and clinical features. The study also evaluates disease-free and overall survival related to pathological response and tumor subtype, providing insights into real-world treatment effectiveness and outcomes in early breast cancer.

Researchers are studying financial toxicity in patients undergoing radiotherapy for cancer in Italy. They use a validated questionnaire called PROFFIT, which measures financial burden and its possible causes in cancer patients receiving radiotherapy. The study aims to compare financial toxicity among different patient groups based on their cancer type, treatment, age, and sex. Participants complete the PROFFIT questionnaire at three times: before starting radiotherapy, at the end of radiotherapy treatment, and 1 to 2 months after treatment during the first follow-up visit. Along with financial toxicity, researchers also explore how changes in financial burden relate to quality of life, side effects, and overall survival using additional questionnaires such as the EORTC QLQ-C30 and PRO-CTCAE. During the study, patients provide information through questionnaires that assess financial distress and quality of life. These assessments occur at baseline, end of treatment, and follow-up up to 12 months. The main outcome measured is the financial toxicity score over this period. This observational study is conducted in multiple centers in Italy and monitors patients' experiences related to financial strain during and after radiotherapy.

Researchers are evaluating ischemic and bleeding risks in patients with severe aortic stenosis who undergo transcatheter aortic valve replacement (TAVR). The study focuses on how different antithrombotic therapies and surgical risk levels affect these risks. It also explores the impact of prosthesis types and blood count variables like hemoglobin and platelets on the likelihood of ischemic and bleeding events after TAVR. The goal is to develop a tailored antithrombotic strategy based on patient risk profiles and therapy trends over time. Participants will be divided based on their surgical risk levels (low, intermediate, high) and the type of antithrombotic therapy they receive at discharge, including single or dual antiplatelet therapy and oral anticoagulation combinations. The study examines changes in antithrombotic treatment at 1 month, 90 days, and 1 year after the procedure. It also considers how different prosthesis features and blood count changes influence risks, using repeated-event analysis to capture these effects. Throughout the study, participants' ischemic and bleeding events will be closely monitored at 30 days, 90 days, and 1 year. Researchers will track the average daily ischemic and bleeding risks, assess how these risks vary by prosthesis type, and observe dynamic changes in antithrombotic therapy over time. Data on therapy adjustments, reasons for changes, and their timing will be collected to better understand real-world treatment patterns and their impact on outcomes.

Researchers are conducting the RICMAF Study, an observational, multicenter research project in Italy, to better understand Anderson-Fabry Disease (AFD), a rare genetic disorder that affects multiple organs, particularly the heart. This disease is often underdiagnosed due to its nonspecific symptoms, which can lead to delays in treatment. The study aims to analyze the clinical profile, genetic factors, and progression of AFD, focusing especially on cardiac involvement, which is a major cause of mortality in affected patients. The study gathers data from a nationwide patient registry including approximately 800 patients diagnosed with AFD according to international guidelines. It includes both retrospective data collection from January 1981 to 2031 and prospective enrollment of new patients. Data comes from medical records and standard clinical evaluations such as specialist visits, laboratory tests, genetic analyses, and cardiac imaging. These evaluations are part of routine care and include assessments like ECG, echocardiography, and cardiac MRI. Participants will be followed over time to collect detailed information on symptoms, family history, genetic mutations, organ involvement, and treatment outcomes. Researchers will use this data to identify early markers of cardiac damage and predictors of cardiovascular complications. The study's primary measure is the natural history of Fabry disease from enrollment through an average follow-up of five years. The study ensures data privacy and follows ethical guidelines, with no additional costs for participants beyond usual care.