Macerata

Researchers are evaluating elacestrant compared to standard endocrine therapies in adults with node-positive, Estrogen Receptor-positive ER, HER2-negative early breast cancer who are at high risk of cancer returning. The study focuses on those who have had prior endocrine therapy and aims to measure how well elacestrant may prevent invasive breast cancer recurrence over five years. Participants are randomly assigned to receive either 345 mg of elacestrant daily for five years or continue their prior standard endocrine therapy, which may include an aromatase inhibitor anastrozole, letrozole, or exemestane or tamoxifen. The trial is open-label, meaning both participants and researchers know which treatment is given. During the study, participants will have regular assessments to monitor cancer recurrence, survival, side effects, and quality of life. Evaluations include questionnaires on health status and physical functioning at baseline, six months, and annually for up to five years. Safety is tracked through adverse event reporting up to five years plus 28 days. The total participation duration can last up to five years with ongoing monitoring and data collection.

Researchers are conducting a Phase III, randomized, open-label multicenter study to evaluate the effectiveness and safety of giredestrant compared with fulvestrant. Both drugs are combined with the investigators choice of a CDK46 inhibitor palbociclib, ribociclib, or abemaciclib in participants with estrogen receptor-positive ER, HER2-negative advanced breast cancer who have become resistant to prior adjuvant endocrine therapy. Participants will be randomly assigned to one of two groups one group will receive giredestrant 30 mg orally daily on Days 1-28 of each 28-day cycle, while the other will receive fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1 and Day 1 of subsequent 28-day cycles. Both groups will also receive a CDK46 inhibitor chosen by the investigator, with dosing schedules depending on the specific inhibitor selected. Preperimenopausal women and men will receive a luteinizing hormone-releasing hormone LHRH agonist during treatment. Participants will be assessed for progression-free survival over up to 5 years, with additional measures including overall survival, response rates, duration of response, clinical benefit, and quality of life. Safety will be monitored through adverse event reporting, vital signs, and laboratory tests during treatment and up to 28 days after the last dose. The study is led by Hoffmann-La Roche and aims to provide detailed information on the treatments effects in this patient population.

This observational study focuses on patients with metastatic Urothelial Carcinoma UC who have been treated with specific therapies. It aims to retrospectively analyze patients who received pembrolizumab as first-line therapy if they were not suitable for platinum chemotherapy, or as second-line therapy after progression following platinum-based chemotherapy. The study also includes patients treated with enfortumab vedotin after progression following platinum chemotherapy and anti-PD-1PD-L1 inhibitors. These analyses help understand treatment outcomes in this patient group. The study examines patients who received at least one cycle of pembrolizumab between January 1, 2018, and November 30, 2021, or at least one cycle of enfortumab vedotin between June 1, 2022, and July 31, 2023. Both treatments are evaluated based on their prior use following platinum-based chemotherapy and progression status. The study does not involve new treatments but reviews patient records to assess outcomes related to these therapies. Participants clinical data will be reviewed to measure overall survival, progression-free survival, and overall response rate to pembrolizumab or enfortumab vedotin. Secondary analysis includes the impact of smoking habits, obesity, and other medications on treatment outcomes. The study involves no active intervention and lasts until September 30, 2027, with data collected retrospectively to better understand treatment effectiveness and patient prognostic factors.

This research aims to gather and analyze real-world data on treatments for patients with metastatic prostate cancer in three specific settings. It focuses on patients with metastatic hormonecastration-sensitive prostate cancer mCSPC treated with androgen deprivation therapy ADT plus androgen receptor signaling inhibitors ARSI or with ADT, ARSI, and docetaxel. It also includes patients with metastatic castration-resistant prostate cancer mCRPC treated with Lutetium-177 PSMA therapy or with PARP inhibitors either alone or combined with ARSI, aiming to understand treatment outcomes across these groups. The study involves observing patients treated with various combinations ADTARSI or ADTARSIdocetaxel for mCSPC Lutetium-177 PSMA therapy for mCRPC and PARP inhibitors such as olaparib, niraparib, or talazoparib alone or with ARSI for mCRPC. These treatments reflect routine clinical management rather than investigational interventions. The study collects data retrospectively from these three patient groups to assess their treatment experiences and outcomes. Participants medical records and treatment histories will be reviewed to evaluate outcomes like overall survival, progression-free survival, and overall response rates for each treatment group. The study also examines time to progression based on metastatic sites and explores how lifestyle and other medications might influence outcomes. This observational study spans from January 31, 2024, to May 31, 2024, focusing on real-world treatment effects without requiring additional interventions or visits from participants.

Researchers are evaluating a mobile health m-health solution designed to support self-management skills in adults with Type 2 Diabetes Mellitus T2DM living in the Marche region of Italy. This randomized clinical trial compares the use of the personalized m-health tool integrated with the Electronic Patient Record EPR against usual diabetes care, focusing on changes in glycated hemoglobin HbA1c levels over an 18-month period. The study aims to enhance patients abilities to manage their condition through technology combined with healthcare collaboration. Participants are randomly assigned to one of two groups the treated group receives regular care plus access to the m-health solution, while the control group continues with standard care alone. The m-health solution includes mobile apps for tracking health data such as blood sugar, lifestyle habits, and diet, receiving alerts and motivational messages, communicating with healthcare professionals, and accessing educational materials. Healthcare providers will monitor patient data through an integrated platform and communicate as needed. The intervention begins at diabetic centers and continues at participants homes. Participants will undergo evaluations at the start and at 6, 12, and 18 months, including clinical assessments, questionnaires, and data collected from the m-health solution. Researchers will assess changes in diabetes severity, medication adherence, lifestyle habits, self-efficacy, quality of life, and the usability and satisfaction with the m-health tool. There are no additional visits or lab tests beyond usual care. The study includes cost-effectiveness analysis and gathers participant feedback to understand their experience with the intervention.

Researchers are investigating the use of Trastuzumab deruxtecan T-DXd in adults with unresectable or metastatic HER2-low and HER2-ultralow breast cancer. This includes patients who have previously received chemotherapy for metastatic breast cancer or have hormone receptor-positive disease treated with endocrine therapy but are unsuitable for further endocrine treatment. The study aims to understand treatment effectiveness, patient characteristics, and experiences in a real-world setting through a non-interventional approach. Participants will be observed while receiving either T-DXd or conventional chemotherapy as part of their routine care, without any drug administration by the study itself. The study includes two groups one with patients having HER2-low breast cancer treated with T-DXd after prior chemotherapy, and another with hormone receptor-positive, HER2-low or HER2-ultralow breast cancer patients treated with either T-DXd or conventional chemotherapy but not prior chemotherapy for metastatic disease. Data will be collected on treatments, side effects, and management of adverse drug reactions. During the study, participants demographic and clinical data, treatment patterns, tolerability, and quality of life will be monitored over approximately 37 months. Assessments include the time to next treatment, treatment discontinuation, physician-reported safety events, patient-reported tolerability, quality of life questionnaires, and symptom diaries. This long-term observation will help evaluate real-world outcomes and patient experiences with T-DXd and conventional chemotherapy in this population.

This research aims to study the epidemiology of invasive bacterial diseases caused by Streptococcus pneumoniae pneumococcus, Neisseria meningitidis meningococcus, and Haemophilus influenzae hemophilus. These infections can cause severe illness and serious complications. The study focuses on monitoring these infections to guide public health efforts, evaluate vaccine impacts, and plan prevention and treatment strategies by identifying circulating strains and assessing vaccine failures. The study uses molecular diagnostic testing to identify these bacteria from blood samples, even when traditional culture methods may fail due to prior antibiotic use or sample handling issues. Pediatric and adult patients diagnosed with invasive bacterial diseases caused by these pathogens are included. This approach enables more accurate detection and characterization of the bacteria. Participants diagnosed with these invasive bacterial infections will have their samples analyzed using molecular methods. Researchers will monitor the incidence rates of these infections in children, the distribution of bacterial types, and the proportion of cases preventable by vaccination. The study will also assess vaccine failure rates. The average study duration for outcome measurement is about one year, supporting improved surveillance and public health interventions.

Researchers are conducting a global registry to monitor the long-term safety and effectiveness of Increlex therapy in children and adolescents with Severe Primary Insulin-like Growth Factor-1 Deficiency SPIGFD. This observational, non-interventional registry collects data from multiple countries including Austria, France, Germany, Italy, Poland, Spain, Sweden, the United Kingdom, and the USA. The main goal is to gather safety information during treatment and for at least five years after treatment ends. The registry includes participants who are starting, planning to start, or already receiving Increlex treatment as per local prescribing information. Increlex mecasermin is given as an injection with doses ranging from 40 to 120 mcgkg twice daily, prescribed by a physician. Data may be collected retrospectively for those already on treatment. The study tracks participants over long periods to observe treatment exposure, dose, and various health outcomes related to growth and development. Participants will be monitored for adverse events, including serious events and neoplasia, during treatment and up to five years afterward. Researchers will also assess changes in height, bone age, body mass index, pubertal stage, and quality of life. Biological markers like growth hormone and IGF-1 levels will be measured periodically. The registry collects comprehensive data on safety, effectiveness, and other health indicators to better understand outcomes in children and adolescents receiving Increlex therapy.

Researchers are conducting the ARON-1 Study, an international and multicenter observational study, to gather worldwide experiences on using immuno-combination therapies for patients with metastatic renal cell carcinoma RCC. This research includes two supplementary studies focused on analyzing genomic signatures from tumor samples and characterizing immune cell populations in patients treated with first-line immuno-combinations for advanced RCC. The treatments being evaluated include combinations such as pembrolizumab plus axitinib, nivolumab plus ipilimumab, nivolumab plus cabozantinib, pembrolizumab plus lenvatinib, avelumab plus axitinib, and atezolizumab plus bevacizumab. These therapies are studied as first-line treatments for metastatic RCC, allowing researchers to compare outcomes across different immuno-combination regimens. Participants provide data retrospectively, with researchers reviewing clinical outcomes such as progression-free survival, overall survival, and overall response rate. Additional analyses focus on treatment efficacy in elderly patients, patients with bone or brain metastases, and those with non-clear cell RCC. The study also examines the prognostic impact of smoking and obesity. Data collection continues until September 2027, with no direct intervention or active treatment administration during the study period.

Researchers are observing adult male patients with metastatic castration resistant prostate cancer mCRPC who are treated with lutetium 177Lu vipivotide tetraxetan. This non-interventional, prospective, multicenter study aims to describe routine clinical practice and gather real-world data on this treatment. The study will follow patients for a maximum of 18 months after their treatment ends. The study includes patients who have been prescribed lutetium 177Lu vipivotide tetraxetan by their treating physician team. There are no additional experimental treatments or interventions, as this is an observational study. The observation period covers from the start of treatment up to 18 months post-treatment, including monitoring during the treatment duration. Participants will be monitored through regular clinical assessments and data collection on outcomes such as progression-free survival, overall survival, prostate-specific antigen response, pain medication use, and quality of life measures. Researchers will also track hospitalizations related to the treatment, dosimetry, number of visits, and workdays lost. The total involvement for each participant can last up to 18 months after treatment completion.