Treviglio

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 evaluating treatments for patients with small cell lung cancer SCLC to determine if brain MRI surveillance alone is not worse than prophylactic cranial irradiation PCI combined with brain MRI surveillance in terms of overall survival. This phase III study also aims to compare cognitive failure free survival, quality of life, cognitive functioning, and safety between these two approaches. Additional exploratory goals include evaluating survival and cognitive outcomes in various patient subgroups and assessing cost-effectiveness. Participants are randomly assigned to one of two groups. One group receives prophylactic cranial irradiation at 25 Gy in 10 fractions plus scheduled brain MRI scans at specific intervals up to 24 months. The other group undergoes active brain MRI surveillance without radiation, with clinical evaluations every three months. Imaging of other body areas is done as needed based on the treating physicians judgment. During the study, participants will have brain MRIs before randomization and at 3, 6, 9, 12, 18, and 24 months. Clinical evaluations will be conducted regularly, and researchers will collect data on survival, cognitive function, quality of life, and treatment safety. Blood samples will also be collected for biobanking. The overall participation lasts up to two years, with ongoing monitoring of health and quality of life.

Researchers are evaluating the clinical performance and long-term safety of scaffold implantation for patients with coronary artery disease in a real-world regional setting. This observational prospective study involves two networks of centers, including all cath-labs in Emilia-Romagna and centers from the MAGIC retrospective study. Investigators have agreed on specific indications and implantation strategies to ensure consistency across centers. The treatment being studied is the implantation of at least one scaffold device during percutaneous coronary intervention PCI. The study focuses on complete revascularization in patients under 65 years, long lesion revascularization especially in the left anterior descending artery, and spontaneous coronary dissection. Implantation strategies include mandatory predilation, precise sizing, avoiding vessels outside specific diameter ranges, and mandatory postdilation with a non-compliant balloon. Participants will be enrolled after approval and followed for safety and outcomes, with adverse events monitored continuously by a Data Safety Monitoring Board. All coronary angiographies and interventions are reviewed by an independent core laboratory to assess adherence to implantation techniques. The primary outcome measured is device-oriented cardiac events at one year, with study participation lasting at least one year to ensure follow-up and compliance.

Researchers are evaluating the study drug sacituzumab govitecan SG Trodelvy GS-0132 IMMU 132 compared to standard of care SOC treatments in participants who have previously been treated for extensive stage small cell lung cancer ES-SCLC. The main goal is to compare how SG versus SOC affects overall survival OS in this population. This is a global, multicenter, randomized, open-label, phase 3 clinical trial focusing on treatment outcomes for ES-SCLC. Participants are randomly assigned to one of two groups. Treatment Group A receives sacituzumab govitecan intravenously at 10 mgkg on Days 1 and 8 of a 21-day cycle, continuing until disease progression, death, unacceptable toxicity, or other reasons for stopping treatment. Treatment Group B receives investigator-selected standard care options within a 21-day cycle, including topotecan given daily on Days 1 through 5, lurbinectedin as an intravenous infusion on Day 1 where approved, or in Japan, amrubicin daily on Days 1 through 3. Treatment continues under the same conditions as Group A. Participants will undergo regular assessments including imaging scans to measure disease status, laboratory tests, and monitoring for side effects. Researchers will evaluate overall survival for up to 4.5 years and secondary outcomes such as progression-free survival, response rates, duration of response, and effects on symptoms like shortness of breath and physical functioning. Safety will be tracked through adverse event reporting and laboratory abnormalities throughout the study duration.

Researchers are creating a large registry of patients with ATTR amyloidosis to better understand the diseases natural history in a real-world setting. This study aims to collect data from diagnosis and during follow-up to develop and validate models that predict outcomes and response criteria at any stage of the disease. The registry also promotes data sharing and collaboration among amyloidosis experts and physicians nationwide, improving diagnosis and management of systemic amyloidosis. The study involves an online registry tool accessible to healthcare providers, facilitating data entry and sharing. This network allows physicians to request diagnostic support from the Amyloidosis Research and Treatment Center ARTC, enhancing patient care through expert collaboration. The registry collects ongoing data during patient follow-up at participating centers. Participants contribute by allowing their clinical data to be included in the registry, either prospectively or retrospectively if they have given informed consent. Researchers will monitor the establishment and use of the online data-sharing tool over five years. The study does not involve experimental treatments but focuses on observation and data collection to improve understanding and management of ATTR amyloidosis.