Potenza

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 elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are evaluating how well guselkumab works to improve symptoms of psoriatic arthritis, an inflammatory joint disease affecting people with psoriasis, by using musculoskeletal ultrasound MSUS in a real-world setting. This observational study aims to collect data from routine clinical practice to better understand treatment effects in participants who have active psoriatic arthritis and meet specific clinical and imaging criteria. Participants with a confirmed diagnosis of psoriatic arthritis who are treated with guselkumab according to their usual clinical care will be enrolled. No study drug is provided by the trial instead, the study collects data available from standard care, including ultrasound exam results. Participants will be asked about their health and well-being during the study. The study includes baseline and follow-up assessments up to 52 weeks to monitor disease activity and response to treatment. During the study, participants will undergo musculoskeletal ultrasound evaluations and clinical assessments at various time points, including baseline, week 12, week 24, and week 52. Researchers will track outcomes such as reduction in synovitis scores, disease activity indexes, pain levels, physical function, and treatment persistence. The study also monitors adverse events. Participation involves routine clinical visits and data collection over approximately one year to observe guselkumab treatment effects in real-world use.

Researchers are conducting a non-interventional, retrospective observational study to better understand the diagnosis and treatment of patients with early-stage and locally advanced non-small cell lung cancer NSCLC, specifically stages I to III. The study addresses the variability in treatment approaches, as there is no clear consensus on the best timing, sequence, or combination of surgery, chemotherapy, and radiotherapy for these patients. This research aims to collect real-world data to improve knowledge on how these patients are managed across different healthcare settings. This study involves reviewing past medical records of patients diagnosed with stage I-III NSCLC who underwent curative surgery or radiotherapy between January 2018 and June 2019. The data collection covers treatment approaches, discussions in multidisciplinary teams, healthcare resource use, and direct medical costs from January 2018 to January 2021. There are no interventions or treatments being given directly as part of this study since it is observational and retrospective. Participants involvement consists of allowing access to their medical charts and treatment records for data capture. Researchers will evaluate treatment timelines and approaches as they occurred in routine clinical practice. The study also tracks the extent of healthcare resources used and costs involved. Data privacy is maintained by obtaining informed consent from patients or their representatives. The study is expected to conclude in June 2025.

This research evaluates whether adding axitinib to nivolumab maintenance treatment after initial therapy with nivolumab plus ipilimumab can improve response rates in patients with metastatic renal cell carcinoma mRCC who have not achieved a complete response or experienced disease progression. The study is a phase II, open-label trial that aims to increase partial response rates based on prior trial results. Participants are randomly assigned to one of two groups one group receives axitinib 5 mg twice daily orally in addition to nivolumab 480 mg intravenously every four weeks, while the other group continues with nivolumab alone at the same dose and schedule. Treatment continues until disease progression, unacceptable side effects, patient withdrawal, or physician decision. The trial plans to enroll 118 patients to detect meaningful differences between groups. Throughout the study, participants will be closely monitored with tumor assessments and health evaluations to measure outcomes such as progression-free survival, overall survival, depth and duration of response, and treatment-related adverse events. Follow-up includes tracking health status and life status from enrollment through treatment and up to 100 days after the last dose. The study is sponsored by Consorzio Oncotech and started in April 2023, with an estimated end date in April 2027.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

Researchers are studying patients with early breast cancer, focusing on those with HER2-positive and Triple Negative tumors who have received neoadjuvant treatment in the past five years. The study aims to understand the percentage of such patients among all who underwent neoadjuvant treatment, along with analyzing treatment choices, tumor characteristics, responses to therapy, surgical procedures, and survival outcomes based on molecular subtypes and initial cancer staging. This observational study reviews clinical data collected from multiple oncology centers in Italy. It examines neoadjuvant treatments given before surgery, the radiological responses assessed by breast MRI, ultrasound, or mammography, and the surgical methods used on the breast and axilla. The study also looks at adjuvant therapies after surgery and tracks changes in eligibility criteria for neoadjuvant treatments over the last five years. Participants medical records will be evaluated to capture information on tumor pathology, treatment responses, and survival rates including disease-free and overall survival. The primary measurement is the percentage of HER2-positive and Triple Negative patients treated neoadjuvantly during the defined period. Secondary analyses include treatment patterns, pathological and radiological responses, surgical details, and correlations between complete pathological response and survival outcomes. The study spans five years of retrospective data and is led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.

This research aims to evaluate financial toxicity FT in patients undergoing radiotherapy for various cancer types in Italy. Financial toxicity refers to the financial burden and distress patients may experience during cancer treatment. The study is observational and multicenter, focusing on assessing FT using the PROFFIT questionnaire, a validated tool designed specifically for Italian cancer patients. Researchers will also explore how changes in financial toxicity relate to quality of life, treatment side effects, and overall survival. Participants will complete the PROFFIT questionnaire, which consists of 16 items measuring financial toxicity and its possible causes. The questionnaire will be administered before starting radiotherapy, at the end of radiotherapy treatment, and during the first follow-up visit 1 to 2 months after treatment. Additional assessments include the EORTC QLQ-C30 questionnaire to measure quality of life and the PRO-CTCAE to evaluate treatment-related symptoms. The study compares financial toxicity across different groups based on cancer type, radiotherapy type, treatment, age, and sex. During the study, patients will be asked to complete questionnaires at specific time points baseline, end of radiotherapy, and first follow-up visit within 1 to 2 months post-treatment, with follow-up up to 12 months. Researchers will monitor financial toxicity scores and analyze how these relate to patients quality of life and treatment effects. Participation involves completing surveys and clinical monitoring without any experimental treatment. The study duration varies depending on individual follow-up schedules.

Researchers are assessing the risks of blood clots ischemic events and bleeding after transcatheter aortic valve replacement TAVR in patients with severe aortic stenosis. This study focuses on how different antithrombotic therapies and surgical risk levels affect these risks. It also explores how the type of valve prosthesis and blood count factors like hemoglobin and platelets influence daily ischemic and bleeding risks over time. The aim is to improve personalized treatment strategies after TAVR. Participants will be grouped based on their surgical risk low, intermediate, or high and the antithrombotic therapy they receive, such as single or dual antiplatelet therapy, oral anticoagulation, or combinations. The study observes changes in antithrombotic treatments at 1 month, 90 days, and 1 year following TAVR. It also examines the impact of prosthesis characteristics and blood abnormalities on risk events using repeated-event analysis. During the study, participants ischemic and bleeding risks will be tracked at 30 days, 90 days, and 1 year after the procedure. Researchers will monitor therapy adjustments, the timing and type of changes, and collect data on anemia and low platelet counts. The study evaluates these outcomes to understand how risks fluctuate over time and how personalized antithrombotic strategies might better manage patients after TAVR.

Researchers are conducting the RICMAF Study, an observational, multicenter, non-drug study in Italy focused on Anderson-Fabry Disease AFD, a rare genetic disorder that affects multiple organs, especially the heart. The study aims to better understand AFDs clinical course, its cardiac complications, and the relationship between genetic mutations and disease progression. This research seeks to improve patient care by identifying early markers of heart involvement and predicting cardiovascular problems. The study collects data from patients diagnosed with AFD according to international guidelines, starting from January 1, 1981, through December 31, 2031. It includes both retrospective and prospective phases, gathering comprehensive clinical, genetic, laboratory, and imaging information through a national patient registry. Patients undergo regular assessments as part of their standard care, including cardiology evaluations, ECG, echocardiography, and cardiac MRI when appropriate. Participants contribute data during routine clinical visits without additional study-specific procedures. The research team collects information from medical records and follow-up visits, including family history, symptoms, genetic tests, and heart monitoring results. The primary outcome is to define the natural history of Fabry disease over an average follow-up of five years, while secondary outcomes focus on cardiac risk stratification, genotype correlations, and early diagnostic biomarkers. The study duration extends up to 10 years, with ongoing data analysis and publication of findings.