Asti

This research aims to evaluate the effectiveness of trastuzumab deruxtecan (T-DXd) in adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have previously been treated with a trastuzumab-based regimen. The study also collects patient demographic and clinical information, treatment patterns, and safety data including serious adverse events and drug reactions. It includes a disease registry for patients receiving conventional therapies in a real-world European setting. The study is non-interventional, meaning no investigational drugs are administered beyond standard care. Patients receiving T-DXd will be treated according to the Summary of Product Characteristics (SmPC), and data on conventional therapies such as platinum-fluoropyrimidine chemotherapy, nivolumab, ramucirumab-paclitaxel, taxane, irinotecan, and pembrolizumab will also be gathered. Treatment choices and administration follow the physician's decision and routine clinical practice. Participants will be monitored from baseline to about two years to assess the time to next treatment. Researchers will collect clinical data, treatment details, tolerability, and patient surveys to understand outcomes and safety. The study involves regular follow-up and data collection to track treatment effectiveness and patient experience in real-world settings.

Researchers are evaluating the safety and effectiveness of pulmonary vein isolation using high power short duration radiofrequency energy in patients with paroxysmal or persistent atrial fibrillation. This prospective, multi-center study aims to understand how clinical and procedural factors relate to the recurrence of atrial fibrillation 12 months after ablation. At least 850 patients will be enrolled to provide reliable data on treatment outcomes and safety. Patients will undergo catheter ablation with approved mapping and ablation catheters. The procedure includes sedation or anesthesia, vascular access through femoral or subclavian veins, and creation of electrical isolation around the pulmonary veins using the QDot Micro catheter at specified power and duration settings. Mapping catheters will verify effective isolation and identify any vein reconnections for additional treatment. Post-procedure assessments include ECG and optional echocardiograms to check for complications. After the ablation, participants will have regular follow-ups at 3 months and detailed evaluations up to 12 months, including physical exams, ECGs, and 24-hour Holter monitoring to detect arrhythmia recurrence. The study will measure the relationship between clinical and procedural details and arrhythmia recurrence rates, with safety and efficacy monitored throughout. Freedom from atrial fibrillation symptoms during follow-up indicates successful treatment.

Researchers are evaluating the safety and effectiveness of combining JSB462 (luxdegalutamide) at doses of 100 mg and 300 mg once daily with abiraterone, compared to an androgen receptor pathway inhibitor (ARPI) such as abiraterone or enzalutamide in adult men with metastatic hormone-sensitive prostate cancer (mHSPC). This Phase II study aims to select the recommended dose of the combination for further Phase III trials by assessing overall efficacy, safety, tolerability, and pharmacokinetics in participants. Participants receive JSB462 orally every day at either 100 mg or 300 mg doses continuously from randomization until disease progression, unacceptable side effects, death, or decision to stop treatment. Alongside this, abiraterone (1000 mg daily) or enzalutamide (160 mg daily) is also given continuously under the same conditions. The study includes a 28-day screening period, followed by the treatment period and then a 30-day post-treatment safety follow-up. After this, a long-term follow-up phase collects ongoing safety, efficacy, and survival data until the study ends. Throughout the study, participants undergo monitoring for prostate specific antigen (PSA) response, adverse events, dose adjustments, and duration of treatment exposure. Safety visits occur 30 days after treatment stops, and long-term follow-up tracks participant health until study completion. The total participation duration varies depending on individual treatment response and follow-up schedules, with assessments continuing for up to approximately 75 months from randomization.

Researchers are investigating the effects of a medicine called BI 690517 in combination with empagliflozin for adults with chronic kidney disease who are at risk of their condition worsening. This study includes people both with and without type 2 diabetes and those already taking certain kidney-related medicines like ACE inhibitors or angiotensin receptor blockers. The goal is to understand if adding BI 690517 helps protect kidney function and reduces risks related to kidney failure and heart problems. This is a Phase 3 clinical trial conducted over about 3 to 4 years. The study has two parts. First, participants receive either empagliflozin or a placebo similar to BI 690517 for at least six weeks, while continuing other indicated treatments like ACE inhibitors or ARBs. In the second part, participants are randomly assigned to take either BI 690517 tablets or placebo tablets once daily alongside empagliflozin for the rest of the study. The placebo tablets look like BI 690517 but contain no active medicine. Participants have regular visits to the study site, about four times in the first six months, then every six months afterward. During these visits, doctors monitor kidney function, heart health, blood pressure, weight, and any side effects. Blood and urine samples are taken to track health changes. The main outcomes measured are the time until worsening kidney disease, hospitalization for heart failure, or cardiovascular death. The study ends when a certain number of these events have occurred.

Researchers are evaluating the use of Percutaneous Stellate Ganglion Block (PSGB) in patients experiencing arrhythmic storm, a serious emergency condition involving multiple sustained ventricular arrhythmias in 24 hours that do not respond to standard antiarrhythmic drugs. This international multicenter observational study, coordinated by Fondazione IRCCS Policlinico San Matteo of Pavia, Italy, aims to assess the safety and effectiveness of PSGB, which has limited large-scale evidence despite growing interest in neuromodulation treatments. Patients who meet the criteria will receive PSGB using one of two common approaches: the anatomical method, which targets Chassaignac's tubercle as the needle insertion point, or the echo-guided method. Depending on patient needs, the doctor may perform either a single injection of anesthetic or a continuous infusion via a catheter connected to a pump. This short-term study observes patients for 24 hours around the procedure. Participants’ arrhythmic episodes and the number of defibrillations will be recorded before and after PSGB to measure reduction in arrhythmic relapses within 12 hours post-procedure compared to 12 hours prior. Researchers will also track complications such as hematomas, vascular or nerve damage, and anesthetic side effects. Data will be collected electronically, and the study will monitor safety and effectiveness outcomes over time, potentially enrolling around 33 patients at the main center with expansion to other sites.

Researchers are collecting epidemiological data on adults newly diagnosed with myelodysplastic syndrome (MDS) to better understand the disease. The study aims to develop a network of Italian regional registries that use a unified electronic case report form to store patient data. This network will allow for the aggregation and analysis of anonymous data from different regions and enable combining this information with other international registries. There are no specific treatments or interventions in this study as it focuses on data collection and registry development. The main goal is to gather consistent and comprehensive epidemiological data through regional registries across Italy. Participants will have their diagnosis and related information recorded in the registry. Researchers will monitor outcomes over six years, including the incidence and prevalence of MDS, overall response rates, survival rates, progression-free survival, and progression to acute myeloid leukemia (AML). The study involves long-term follow-up to track these outcomes and improve understanding of MDS epidemiology.

Researchers are studying men with metastatic castration-resistant prostate cancer (mCRPC) who are treated with lutetium (177Lu) vipivotide tetraxetan. This study is a long-term, prospective, multicenter, observational research project designed to describe routine clinical use of this treatment in real-world settings. The focus is on understanding patient experiences and outcomes outside of clinical trials. The study observes patients receiving lutetium (177Lu) vipivotide tetraxetan as prescribed by their doctor, without any experimental interventions introduced by the study itself. The observation period starts from the beginning of treatment and continues for up to 18 months after treatment ends. No additional procedures or changes to treatment are made by the study team. Participants will be monitored through regular clinical assessments to track their progression-free survival, which measures how long patients remain free from disease worsening after treatment. The study collects primary data during this observation to provide insight into the real-world effectiveness and safety of lutetium (177Lu) vipivotide tetraxetan for men with mCRPC. Overall, involvement in this study lasts up to 18 months post-treatment.

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 evaluating a structured telenursing intervention to support women with breast cancer who are receiving cyclin-dependent kinase (CDK) inhibitor therapy. These treatments can cause side effects like blood problems, gastrointestinal symptoms, and fatigue, which may lead to treatment interruptions and increased hospital visits. The study aims to see if regular remote nursing follow-ups can help detect and manage these side effects early to improve treatment outcomes and patient safety. Participants are randomly assigned to either standard care or standard care plus a structured telenursing program. The telenursing involves scheduled telephone or video calls by trained oncology nurses at set times during each treatment cycle (for example, around days 7, 14, and 21). During these calls, nurses assess symptoms, provide education, support treatment adherence, and identify early signs of side effects that need medical attention. If needed, patients are quickly referred to their doctors for further care. Throughout the study, data on side effects, emergency visits, hospitalizations, treatment adherence, dose changes, and patient-reported outcomes are collected. The main measure is the incidence of treatment-related adverse events during six months from treatment start. Participants are monitored using standardized forms and institutional records. The study seeks to provide evidence supporting the use of telenursing programs to enhance care and improve clinical outcomes for breast cancer patients on CDK inhibitors.