Viterbo

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 conducting an observational, prospective, multicenter study in Italian cardiology centers to evaluate how well patients with Heart Failure with Reduced Ejection Fraction (HFrEF) follow guideline-recommended treatments. The study also aims to assess the safety of these treatments, monitor treatment patterns in patients with acute heart failure, and observe treatment approaches in all chronic heart failure patients regardless of their ejection fraction levels. The study involves two phases of educational interventions and data collection. Initially, healthcare providers will receive education on guideline recommendations and treatment patterns, followed by 3 months of patient data collection or up to 30 consecutive patients with chronic or acute heart failure. After 6 months, treatment modifications and outcomes will be evaluated. Then, a second educational session will highlight gaps between guidelines and practice, followed by another 3 months of data collection. Patients will be followed for 12 months total, with ongoing monitoring of treatment changes and outcomes. Participants will be assessed at enrollment and during the follow-up periods through clinical evaluations and data collection on treatment adherence and safety. The main outcome measured is adherence to guideline-directed medical therapies over 6 months. The study includes evaluations at 6 and 12 months after enrollment, with close monitoring of treatment patterns and patient health status throughout the study duration.

Researchers are evaluating patients who have experienced athero-thrombotic events such as coronary artery disease, cerebrovascular disease, or peripheral artery disease. The study aims to assess how well patients follow guideline recommendations, particularly focusing on improving cholesterol levels and other modifiable risk factors to reduce the chance of cardiovascular event recurrence. This observational and prospective study takes place across multiple cardiology centers in Italy to represent a broad patient population. The study includes several phases starting with an educational intervention to discuss guideline recommendations for secondary prevention. Following this, data is collected for three months or until 30 patients with documented cardiovascular conditions are enrolled, using a web-based case record form that identifies when guidelines are not followed and records reasons for non-adherence. After six months, primary and secondary outcomes are evaluated. A second educational intervention then shares findings from the first phase to highlight gaps in clinical practice, followed by another three-month data collection period and a further six-month outcome assessment. Finally, all patients are followed for 12 months to monitor longer-term results. Participants provide informed consent and are monitored through data collection forms that track adherence to guidelines and clinical outcomes. The main outcome measured is adherence to cholesterol management guidelines over six months. Additional assessments include adherence to recommendations for other cardiovascular risk factors. Throughout the study, researchers gather data to understand how guideline adherence affects patient health and to identify barriers to following best practices, with continuous follow-up over a year to evaluate sustained effects.

Researchers are studying patients with Philadelphia chromosome-negative myeloproliferative neoplasms (MPN Ph negative) to observe inflammatory biomarkers and how these markers change over the course of the disease. The study aims to find links between these biomarkers and disease outcomes, focusing especially on the occurrence of blood clotting (thrombo-haemorrhagic) events and the progression to more severe disease phases. The goal is to develop new tools for better and quicker risk assessment in these patients. This is a multicenter, retro-prospective observational study that follows patients diagnosed with polycythemia vera, essential thrombocythemia, primary myelofibrosis, or related myelofibrosis types. Participants are observed over time without receiving experimental treatments. The study collects blood samples to measure inflammatory markers and monitors disease progression and complications. Participants will be followed for up to 60 months during which blood tests including complete blood count with leukocyte formula will be performed to calculate specific ratios (NLR and PLR). Researchers will track the occurrence of arterial and venous blood clots and other disease events. This long-term monitoring will help understand the role of inflammation in disease outcomes and response to therapy.

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 conducting an open-label, randomized, multicenter phase III study to evaluate the feasibility of allogeneic stem cell transplantation (HSCT) in patients with higher-risk myelodysplastic syndromes (HR-MDS). The study compares two approaches: hypomethylating therapy (HMT) followed by HSCT versus HSCT upfront in patients with less than 10% bone marrow blasts, and conventional chemotherapy (CHT) versus HMT followed by HSCT in patients with more than 10% bone marrow blasts. This non-inferiority trial aims to assess which treatment strategy is more feasible based on the proportion of patients who successfully receive HSCT over four years. Participants receive treatments based on their bone marrow blast counts. Those with under 10% blasts receive azacitidine, administered as 75 mg/m2 subcutaneously daily for 7 days every 28 days, followed by HSCT or HSCT upfront. Patients with more than 10% blasts are treated with standard chemotherapy consisting of two cycles of intravenous induction and consolidation therapy using cytarabine and daunorubicin before HSCT. The study compares these treatment regimens to determine the best sequence for transplantation. During the study, participants are closely monitored for treatment feasibility, including assessments of successful HSCT receipt. Researchers evaluate outcomes over a four-year period, focusing on the proportion of patients completing the transplantation process. Patients must meet specific health criteria and provide informed consent. Safety and treatment adherence are observed throughout the trial, ensuring comprehensive data on the transplantation strategies in HR-MDS patients aged 18 to 70 years.

Researchers are investigating the effectiveness of adding Atezolizumab to a chemotherapy combination of FOLFOXIRI plus bevacizumab as the first treatment for patients with metastatic colorectal cancer that has proficient mismatch repair (pMMR) and high Immunoscore IC. This phase III, open-label, multicenter trial focuses on patients with initially unresectable and untreated metastatic colorectal cancer. The main goal is to compare how well patients do in terms of progression-free survival over 24 months when treated with these regimens. Participants will be randomly assigned to one of two groups: one group receives FOLFOXIRI plus bevacizumab for up to 8 cycles, followed by maintenance therapy with 5-FU/LV plus bevacizumab; the other group receives the same chemotherapy plus atezolizumab, followed by maintenance including atezolizumab as well. Treatment continues until disease progression, unacceptable side effects, or patient choice. The study accounts for differences in patients' performance status, tumor location, and liver metastases. After the study treatment, further therapies are chosen by the investigators. Throughout the study, patients will undergo regular assessments including scans and laboratory tests to monitor disease status and safety. Researchers will track progression-free survival as the primary outcome over two years. Participants must meet specific health criteria and agree to follow the study procedures over the treatment and monitoring periods. The study aims to better understand the benefits of adding immunotherapy to standard chemotherapy in this patient group.

This research aims to evaluate the use of HIV pre-exposure prophylaxis (PrEP) in Italy by establishing a large prospective cohort of HIV-negative adults who are sexually active and eligible for PrEP. The study focuses on assessing PrEP's effectiveness, tolerability, adherence, and barriers to long-term use in a real-world setting. It also monitors the incidence of new HIV infections and other sexually transmitted infections (STIs), along with psychological, behavioral, and treatment factors related to PrEP use. Participants include about 5,000 adults aged 18 years or older who are either starting or already using PrEP according to national and international guidelines. The study is conducted across 49 university and hospital infectious disease clinics and 4 community-based checkpoints throughout Italy. Participants attend routine clinical visits every 3 to 5 months, where they undergo HIV and STI testing, safety laboratory tests, and complete electronic questionnaires through a dedicated mobile app. The study will continue for at least 10 years and is coordinated by the National Institute for Infectious Diseases "L. Spallanzani" IRCCS in Rome. During the study, researchers collect sociodemographic, clinical, laboratory, behavioral, and quality-of-life data in a secure electronic case report form managed by the ICONA Foundation. The main outcome measured is the incidence of HIV seroconversion from enrollment onward. Secondary outcomes include monitoring STIs, evaluating PrEP safety and tolerability, and analyzing adherence, persistence in care, and related behavioral factors. Ethics committees at all participating centers have approved the study, ensuring participant safety and confidentiality throughout the long-term follow-up.

Researchers are studying adults with primary or secondary myelofibrosis, a type of bone marrow disorder, who have started treatment with ruxolitinib as part of their usual care. This observational study looks at patient records from multiple centers and follows patients over time to understand how clinical and lab characteristics affect long-term survival. The study collects data from routine clinical tests and investigations, including laboratory tests, histology, cytogenetics, molecular studies, and imaging, all done as part of standard care. Information on symptoms and spleen enlargement is gathered at diagnosis and during regular disease assessments. The study follows patients for a minimum of 3 months, with a planned total duration of 10 years to evaluate outcomes. Participants provide informed consent for data collection. Researchers review clinical history before starting ruxolitinib and monitor patients over time using data from normal clinical practice. The main outcome measured is long-term survival over 10 years. This approach allows for understanding the prognosis of patients treated with ruxolitinib under real-world conditions.