Carpi

Researchers are evaluating if a combination of atezolizumab and standard chemotherapy can improve treatment outcomes for patients with sensitive relapse Extensive-stage Small Cell Lung Cancer ES-SCLC who have progressed after first-line treatment with platinum-etoposide chemotherapy plus PD-L1 inhibitors like atezolizumab or durvalumab. This phase II trial is designed to find out if continuing PD-L1 inhibition along with rechallenge chemotherapy increases overall survival and to monitor medical problems participants may experience. Eligible patients receive induction treatment with atezolizumab 1200 mg given intravenously on day 1 every 3 weeks along with carboplatin and etoposide chemotherapy for up to 4 cycles. After induction, patients continue maintenance therapy with atezolizumab every 3 weeks for up to 18 cycles or one year. Treatment continues until disease progression, unacceptable side effects, patient choice, or loss of clinical benefit. The study spans an expected 45 months, including 24 months for recruitment, 15 months maximum treatment duration, and up to 6 months of follow-up. Participants visit the clinic every 3 weeks for treatment, checkups, and tests. Radiological assessments using CT scans are done at 6 weeks, 12 weeks, and then every 12 weeks to check treatment response. Researchers continuously monitor safety and adverse events during treatment. The primary outcome is overall survival over about one year, with additional measures including progression-free survival and the frequency of adverse events. Participants are closely observed throughout the study to evaluate treatment effects and safety.

Researchers are studying metastatic breast cancer in a program aiming to recruit 1300 patients from hospitals across Europe. Eligible participants are adults aged 18 or older, male or female, with a recent diagnosis of metastatic or locally advanced breast cancer or disease relapse who have not received more than one type of treatment for metastases. The goal is to better understand genetic changes in metastatic breast cancer and discover how tumors respond or resist therapy to eventually identify the most suitable treatment for each patient. The study is sponsored by the Jules Bordet Institute and focuses on molecular analysis of cancer samples. Participants will undergo a biopsy of a metastatic lesion either at program entry or up to six months before inclusion, and a sample of the primary tumor must be available. Blood, serum, and plasma samples will also be collected. These samples will be analyzed centrally, and any unused samples will be stored in a bio-repository for future research. The study offers the possibility for patients with certain genetic changes to join related clinical trials if available and approved in their country. Throughout the study, participants provide blood samples at screening and regular intervals during follow-up. Researchers will evaluate genetic alterations, identify exceptional responders and rapid progressors, and assess patient prognosis over up to 10 years. The study will also monitor the feasibility of molecular screening and correlate molecular findings with standard measures of treatment response. The total study duration extends to March 2031, with primary outcome review planned one year after recruitment ends.

This observational study investigates the impact of surgical centralization and treatment strategies on oncologic outcomes in female patients diagnosed with epithelial ovarian cancer EOC between 2018 and 2023 within the Emilia-Romagna region in Italy. The study aims to compare progression-free survival and overall survival across three time periods before centralization and the COVID-19 pandemic, during the pandemic peak, and during the post-pandemic control phase. This research is conducted by the AUSL-IRCCS of Reggio Emilia and includes both retrospective and prospective components. Participants are grouped based on when they received treatment prior to centralization and the pandemic 2018-2019, during the peak pandemic with changes in care due to resource limitations 2020-2021, and after the pandemic peak reflecting new care standards 2022-2023. No experimental treatments are given, as all patients receive standard care according to routine clinical practice. The study observes variations in surgical approaches, chemotherapy, and use of therapies like Bevacizumab and PARP inhibitors. Throughout the study, participants clinical records and outcomes are reviewed retrospectively, with ongoing clinical follow-up planned for up to five years. Researchers assess survival rates, treatment types, tumor characteristics, recurrence patterns, and use of secondary treatments including surgery and radiotherapy. Data collection includes information from multidisciplinary tumor boards and patient consents. The study spans until June 2031, allowing comprehensive evaluation of long-term outcomes.

Researchers are evaluating the effectiveness and safety of bowel cleansing using 100 g Mannitol compared to the standard Plenvu same-day dosing regimen for people undergoing elective colonoscopy. This Phase III international study aims to determine if Mannitol is not worse than Plenvu in preparing the bowel for colonoscopy. The study is randomized, parallel-group, and endoscopist-blinded to ensure unbiased results. Participants are randomly assigned to one of two groups. One group will self-administer a single dose of 100 g Mannitol dissolved in 1 liter of water within 45 minutes on the day of colonoscopy. The other group will follow a split-dose regimen of Plenvu the same day, involving dissolving doses in water and drinking specified amounts over a period with a waiting time between doses. Both groups consume a total of 2 liters of preparation liquid. During the study, participants will undergo colonoscopy within 28 days of signing consent, where bowel cleansing quality will be assessed using the Boston Bowel Preparation Scale. Researchers will also measure adenoma detection rate, cecal intubation rate, repeat colonoscopy rates, and presence of colonic bubbles. Participants must complete the entire study and follow instructions. Safety and patient acceptance will also be monitored throughout the trial period.

Researchers are evaluating the clinical characteristics and procedural outcomes of patients receiving permanent cardiac pacing to treat various heart rhythm disorders. This observational study compares the effectiveness and safety of different device implantation methods used in routine clinical practice, including the contribution of advanced non-fluoroscopic anatomical and electrophysiological mapping systems. The study focuses on patients over 18 years old who require a pacemaker or intracardiac defibrillator implant following European Society of Cardiology guidelines. The study includes several types of cardiac pacing approaches conventional right ventricular pacing, conduction system pacing such as His bundle or left bundle branch area pacing, cardiac resynchronization therapy CRT with biventricular or left ventricular pacing, epicardial pacing often done during cardiac surgery, and leadless pacing via a percutaneous femoral vein approach. Each method involves implantation of a device connected to cardiac leads positioned in specific heart locations, with vascular access through veins like the cephalic, axillary, or subclavian. Electrical parameters such as pacing threshold and sensing are measured to ensure device stability before final placement. Participants will be followed for up to 120 months with clinical and procedural data collected, including assessments of device efficacy and safety at 30 days, 6 months, and 12 months. Outcome measures include stable electrical device performance, absence of cardiovascular hospitalizations or death, and monitoring for heart failure or arrhythmia events. The study also tracks procedural times, radiation exposure, and complications such as infections or lead dislocations. This long-term observation aims to understand the benefits and risks of various pacing strategies in real-world settings.

Researchers are studying the role of Human Endogenous Retroviruses HERVs, ancient DNA sequences, and gut microbiota in children with various inflammatory diseases such as Kawasaki Disease, IgA VasculitisSchonlein-Henochs Purpura, SARS-CoV-2 infection, and febrile virosis. The study aims to understand how HERVs and gut bacteria might influence immune responses and disease symptoms in pediatric patients. This research could provide new insights for managing and treating these conditions. The study involves collecting blood and fecal samples from children diagnosed with the listed diseases. Blood samples are analyzed to study HERVs, while fecal samples are used to characterize the gut microbiota. Patients are enrolled consecutively as they receive a diagnosis, and the study monitors changes over approximately one year to assess associations between HERVs, gut bacteria, and clinical outcomes. Participants will have evaluations including sample collection for laboratory analyses. Researchers will measure HERV activity and gut microbiota profiles to explore their links with disease manifestations. The primary outcomes focus on these analyses throughout the study period, enabling a better understanding of immune regulation in these pediatric inflammatory diseases. The study is expected to last about one year for each participant.

Researchers are conducting a multicenter, observational study in Italy to collect detailed information on patients with bone metastases. The study aims to establish a national database to better understand clinical and biological factors related to primary tumors and their bone metastases. This research will also evaluate the impact of treatments and care pathways on skeletal events over a period of up to 15 years. Patients with bone metastases from solid tumors will be enrolled in this study and registered in a specialized online database. Each participant will be followed from enrollment until death or until they stop follow-up for other reasons. The study does not involve any experimental treatments but collects comprehensive data on patients conditions and care. Participants will provide informed consent and their medical data will be regularly recorded and analyzed. The study monitors clinical outcomes, skeletal-related events, and the efficiency of treatment pathways. Data collection will continue for up to 15 years, providing long-term insights into bone metastases and patient management.

Researchers are investigating whether using a genetic test called Prosigna4 can help decide if chemotherapy is necessary for premenopausal women with hormone receptor-positive HR and HER2-negative breast cancer. This study aims to determine if treatment guided by this test produces similar outcomes to the standard approach of systematic chemotherapy. The trial focuses on younger women who often experience more side effects from chemotherapy, affecting their quality of life and work capacity. Participants will be randomly assigned to one of two groups. In the experimental group, treatment depends on the Prosigna4 score women with a high score above 60 will receive chemotherapy plus hormone therapy, while those with a lower score will receive only hormone therapy with ovarian suppression. The control group will receive the standard treatment of chemotherapy followed by hormone therapy. The study includes a pre-inclusion period for eligibility testing and randomization. Throughout the study, participants will complete questionnaires about quality of life, treatment side effects, emotional well-being, and other health measures for up to five years after randomization. Researchers will monitor cancer recurrence, survival, fertility, osteoporosis, cardiovascular disease, and other outcomes. Regular assessments include physical activity levels, adherence to therapy, and patient perceptions of treatment and participation, aiming to evaluate the safety and impact of treatment guided by the genetic test.

This research focuses on infant weaning, the process of transitioning from exclusive milk feeding to a varied diet that supports healthy development. It explores different weaning methods, including traditional spoon-fed foods and baby-led approaches, and aims to understand how parents and pediatricians perceive the advantages and disadvantages of these methods. The study also investigates potential risks, such as feeding errors or choking hazards, during this dietary transition. Participants include two groups parents of children aged 4 to 18 months and free choice pediatricians PLSs in Italy. Parents will complete a questionnaire about their weaning practices, while pediatricians will answer a separate survey regarding their advice on weaning modes and food choices. The study collects data over about one year to assess the prevalence and perspectives on weaning methods. Throughout the study, parents and pediatricians will provide information via questionnaires accessed electronically. Researchers will evaluate how weaning is implemented and the suggestions pediatricians offer concerning weaning. The study aims to gather insights on weaning practices and safety, including potential risks like choking, by analyzing the questionnaires completed within the study period.