Mirano

Researchers are studying women who carry mutations in the breast cancer susceptibility genes BRCA1 and BRCA2 to better understand their risk of developing cancer. This observational study aims to collect national data from women with these mutations, as current management strategies are not fully established. The study focuses on the Italian population, where an estimated 140,000 to 150,000 women carry these mutations, and many face a high lifetime risk of genetically linked tumors. Participants will be registered on a platform where their clinical data related to BRCA1 or BRCA2 mutations will be collected. The study does not involve treatment but gathers detailed information about mutation distribution, access to genetic evaluation, lifestyle risk factors, preventive strategies, and surgical risk reduction approaches such as salpingo-oophorectomy. Women in the study will provide data that researchers will analyze to understand mutation geography, related cancer types, and screening criteria. Data collection occurs over different time frames, including immediate and six-month intervals. The study continues through long-term observation to monitor outcomes and preventive efforts, with no active intervention applied to participants.

Researchers are investigating advanced breast cancer that is hormone receptor-positive and HER2-negative, focusing on patients receiving first-line treatment with CDK46 inhibitors combined with endocrine therapy. The study is observational and multicenter, aiming to gather real-world evidence from clinical data, medical imaging, and biological samples. The study includes various sub-studies that address different aspects of treatment outcomes and patient responses. The study involves collecting data from five sub-studies real-world clinical data comparing survival outcomes among patients treated with three CDK46 inhibitors safety data on comorbidities, medications, and toxicities medical imaging analyses using CT and PET scans genomic and transcriptomic analyses from tumor samples and evaluation of treatment patterns after progression on first-line therapy. These sub-studies use different methods for data collection, extraction, and analysis to build predictive models to assist treatment decisions. Participants will have their medical records reviewed for clinical outcomes, imaging studies collected and analyzed, and biological samples obtained for molecular testing. Researchers will assess overall survival up to 120 months from treatment start, along with progression-free survival and time to subsequent treatments. The study tracks severe toxicities and gathers detailed comorbidity information to understand treatment safety. Participant involvement is based on data collection rather than active treatment assignment, with the study continuing through various follow-up periods to monitor long-term outcomes.

Researchers are evaluating INCB123667 compared to the investigators choice of chemotherapy in adults with platinum-resistant ovarian cancer characterized by cyclin E1 overexpression. This Phase 3 trial aims to assess treatment outcomes in participants who have specific tumor types and prior treatment histories. The study focuses on participants with high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who meet detailed criteria for platinum resistance and prior therapies. Participants are randomly assigned to receive either INCB123667 as an oral tablet or chemotherapy selected by the investigator following protocol guidelines. The chemotherapy options are defined by the study protocol, and both treatments are given at protocol-defined doses. The trial includes two experimental treatment groups and does not use masking or blinding. Treatment continues with monitoring over a period of up to two years. Throughout the study, participants undergo regular assessments including tumor measurements by RECIST criteria, safety evaluations for adverse events, and quality of life questionnaires such as the EORTC QLQ-Core 30 and EQ-5D-5L. Researchers will monitor progression-free survival and overall survival as primary outcomes, along with response rates and treatment tolerability. The total study duration for participants may extend up to two years, with close follow-up to evaluate treatment effects and safety.

Researchers are evaluating the long-term clinical and instrumental response to Cardiac Contractility Modulation CCM therapy in adults with symptomatic heart failure caused by systolic left ventricular dysfunction despite adequate medical treatment. This observational cohort study, both retrospective and prospective, focuses on subjects already receiving CCM as part of their regular care. The study aims to assess clinical response, hospitalizations, quality of life, walking distance, and changes in heart biomarkers over 12 months. Participants carry the OPTIMIZER Smart Mini CCM device, a programmable implantable pulse generator connected to leads in the heart. The study groups are defined by their response to low-dose dobutamine stress echocardiography before implantation, with one group showing a reduction of 15% or more in left ventricular end-systolic volume LVESV and the other less than 15%. The low-dose dobutamine test involves incremental infusions of the drug to assess heart contractile reserve. During the 12-month follow-up, researchers will monitor changes in New York Heart Association NYHA class, hospitalizations, quality of life using the Minnesota Living with Heart Failure Questionnaire, walking test distance, and NT-proBNP biomarker levels. Additional assessments include echocardiographic measures and recording adverse events, cardiac device implants, or surgery. This comprehensive monitoring helps evaluate the clinical and functional effects of CCM therapy over time.

This research evaluates whether transcatheter aortic valve implantation TAVI can be safely and effectively performed in hospitals without on-site cardiac surgery for patients with severe symptomatic aortic stenosis. The study compares outcomes between centers without on-site cardiac surgery and those with such facilities, focusing on clinical results one year after the procedure. It builds on earlier findings that suggest selected patients may have safe access to TAVI even without immediate surgical backup, given proper safeguards and experienced operators. Participants will be randomly assigned to receive TAVI either in a center lacking on-site cardiac surgery but equipped with experienced operators, advanced imaging, and rapid transfer protocols, or in a center with on-site cardiac surgery. The procedure will be performed according to current guidelines and local standards by skilled TAVI operators. Both study arms involve the same procedure but differ in the setting, allowing assessment of safety and effectiveness in these different hospital environments. During the study, participants will undergo thorough evaluations before the procedure, including clinical, imaging, and laboratory tests to confirm eligibility. After the procedure and hospital discharge, they will be followed for one year to monitor clinical events such as death, stroke, and hospitalizations related to the procedure or valve. An independent committee will review clinical events while patient safety is overseen by a monitoring board, aiming to ensure reliable and unbiased assessment of outcomes.