Crema

Researchers are studying patients with hormone receptor-positive, HER2-negative early breast cancer HRHER2- EBC who are at high risk of their cancer returning. This observational study includes both past and future phases to assess the clinical and pathological features, treatment choices, and outcomes of patients treated with CDK46 inhibitors ribociclib or abemaciclib combined with endocrine therapy in the adjuvant setting. The study also focuses on patients whose cancer returned during or within 12 months after finishing this adjuvant treatment. Participants are those who have started or are starting adjuvant treatment with ribociclib or abemaciclib along with endocrine therapy since January 1, 2021. This study does not involve assigning treatments but observes patients receiving these therapies in real-world settings. It gathers data on treatment patterns, recurrence, and clinical outcomes without altering patient care. During the study, researchers will collect and analyze data on patient health, tumor characteristics, and treatment responses. They will track invasive disease-free survival over 3 years as the main outcome, along with distant relapse-free survival, progression-free survival, and overall survival up to 5 years. Participants will provide consent for their data to be used, and their health status will be monitored through routine medical records and follow-ups. The study is expected to continue until August 2030.

Researchers are studying patients with advanced pancreatic cancer that cannot be removed by surgery or has spread to other parts of the body. The trial compares two chemotherapy approaches after an initial treatment period continuing the current chemotherapy regimen called mFOLFIRINOX or switching to a different chemotherapy combination of gemcitabine plus nab-paclitaxel. This phase III randomized trial aims to find out which approach helps patients live longer without disease progression after three months of initial chemotherapy. Participants first receive mFOLFIRINOX chemotherapy every two weeks for about 14 weeks, with at least 4 cycles required to continue in the trial. Those whose cancer has not worsened are then randomly assigned to one of two groups. One group continues mFOLFIRINOX, which includes oxaliplatin, irinotecan, leucovorin, and 5-fluorouracil given by infusion every two weeks. The other group switches to gemcitabine and nab-paclitaxel, given on days 1, 8, and 15 in 28-day cycles. Treatment continues until the cancer progresses, side effects become unacceptable, the participant withdraws consent, or death. During the study, participants will have regular scans to monitor their cancer and assessments to track side effects, quality of life, and treatment response. Researchers will measure overall survival up to 48 months after randomization, along with progression-free survival, time until treatment stops, and other health outcomes. The trial includes ongoing evaluations of toxicity and quality of life to understand the impact of each treatment approach on patients. Participants remain under close medical supervision throughout the study period.

Researchers are studying patients experiencing arrhythmic storm, a serious heart condition characterized by frequent and sustained ventricular arrhythmias that do not respond to standard antiarrhythmic drugs. This international multicenter observational study aims to evaluate the safety and effectiveness of Percutaneous Stellate Ganglion Block PSGB in reducing arrhythmic relapses in such emergency cases. The study is coordinated by Fondazione IRCCS Policlinico San Matteo of Pavia, Italy, and addresses a gap in large-scale data on this procedure. Participants who meet the criteria will receive PSGB using either the anatomical or echo-guided approach. Depending on patient needs, the procedure may involve a single anesthetic injection or continuous anesthetic infusion via a catheter connected to a pump. The study compares the number of arrhythmic events and defibrillations before and after PSGB treatment and notes any complications occurring within 12 hours post-procedure. During participation, patients will be monitored closely for arrhythmic relapses using defibrillation counts and anti-tachycardia pacing data. Complications such as hematomas, vascular injuries, and nerve damage will be recorded. Data are collected using a secure electronic system, with effectiveness measured by arrhythmic event reduction in the 12 hours following PSGB compared to the 12 hours prior. The study plans to enroll patients over several years with ongoing safety and outcome evaluations.

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.