Higashi-morokata, Japan

National Database of Bone Metastases

Exposures to Perinatal Adverse Experiences: Multimodal Omics Signature of Stress Vulnerability and Resilience and Preventive Strategies

National Register of Actionable Mutations

The primary objective of this observational study is to describe the frequency of actionable mutations in patients with solid tumors in advanced stage, receiving a genetic-molecular characterization with high throughput methods. The secondary objectives are: 1. assess the correlation between genetic alterations and clinical and pathological characteristics of enrolled patients (gender, age, histological variant, location and extent of neoplasm, comorbidity, familiarity for neoplasms); 2. describe, where possible, any variation in the molecular profile for patients who are subjected to genetic screening analysis at different stages of the disease. 3. record retrospectively clinical efficacy and toxicity data when patients were treated with a target therapy based on the detected molecular alterations. The national register of actionable mutations will be created collecting the following data: 1. Data extracted retrospectively from medical records of patients that have received during the study period a test with high-throughput technologies for the molecular characterization of their tumor, either by clinical routine or for research purposes. 2. Data collected prospectively from analysis of biological samples (FFPE and biopsy liquid) of patients that meet the elibility criteria and that perform the molecular-genetic screening using Foundation Medicine services or in selected italian laboratories. 3. Clinical data collected retrospectively (RR, DOR, PFS, OS, toxicity), in case where the patients are treated with a target therapy, based on the highlighted molecular alterations and on the choice of the clinician. Only samples already available for clinical practice will be used in the study. The register will be limited to collecting information on molecular alterations that can then be used for the insertion of patients in clinical studies already active, for the design of new studies proposed by members of the Steering Committee or of the participating sites, or for treatment with other modality.

PRophylactic Cerebral Irradiation or Active MAgnetic Resonance Imaging Surveillance in Small-cell Lung Cancer Patients (PRIMALung Study)

The primary objective is to test with a one-sided significance of 5% whether for the treatment of small cell lung cancer (SCLC) patients, brain MRI surveillance alone is non-inferior in terms of overall survival compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the entire study population under the treatment policy strategy. The secondary objectives are: - To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of cognitive failure free survival (CFFS) compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. - To test with a one-sided type I error of 2.5% whether brain MRI surveillance is superior in terms of global health status/QoL and cognitive functioning according to EORTC QLQ-C30 questionnaire compared to prophylactic cranial irradiation (PCI) combined with brain MRI surveillance in the study population. - To evaluate the frequency and severity of toxicities according to CTCAE v5.0 in the two arms in the treated population (i.e. patients who have started treatment). The exploratory objectives are: - To compare OS and CFFS between the arms within the subgroups of patients with LS and ES disease. - To compare OS and CFFS between the arms within the subgroups: HA-PCI or not, first-line immunotherapy or not, memantine or not. - To compare cognitive failure free survival (CFFS) rate at 12 months after randomization between the arms. - To compare the cumulative incidence of cognitive failures with death as a competing risk between the arms. - To compare brain-metastasis-free survival (BMFS) between the arms. - To compare progression free survival (PFS) between the arms. - To compare time to brain-metastasis-attributed death (TBMAD) between the arms. - To compare other QoL scales according to EORTC QLQ-C30 and QLQ-BN20 questionnaires between arms. - To evaluate the cost-effectiveness of MRI surveillance alone versus MRI surveillance combined with PCI. - To collect blood for biobanking.

A Study of Milvexian in Participants After a Recent Acute Coronary Syndrome