Ansbach

Researchers are evaluating the real-world effectiveness, safety, and patient compliance of ribociclib combined with an aromatase inhibitor for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. This observational study also compares ribociclib treatment with abemaciclib plus endocrine therapy and endocrine therapy alone, aiming to better understand treatment decisions and clinical adoption in routine practice. The study is conducted across breast centers and gynecological practices to represent typical healthcare settings. Participants receive treatment based on their physicians clinical judgment without randomization or intervention assignment. The study collects data from patients treated with ribociclib plus aromatase inhibitor with or without luteinizing hormone-releasing hormone LHRH, abemaciclib plus endocrine therapy with or without LHRH, or endocrine therapy alone with or without LHRH. Baseline data and follow-up information on adverse events, quality of life, treatment adherence, and socio-economic factors are gathered over time. During the study, participants undergo assessments including evaluation of invasive disease-free survival up to 36 months, quality of life questionnaires, medication adherence reports, and monitoring of adverse events and treatment changes. Data on reasons for treatment decisions, patient perceptions, and healthcare provider involvement are also collected. The study duration extends up to 39 months to provide a comprehensive overview of treatment impact and patient experience in real-world clinical settings.

Researchers are conducting a prospective observational study to examine asthma control, health-related quality of life HRQL, lung function, and asthma medication use in patients with severe eosinophilic asthma treated with benralizumab in routine clinical practice settings in Germany. The study aims to gather real-world evidence on these patients over a 52-week period. Participants will be treated with benralizumab as part of their standard care, and no additional treatment will be assigned by the study. Asthma control will be assessed using the Asthma Control Test ACT and the Asthma Impairment and Risk Questionnaire AIRQae at various timepoints. Health-related quality of life will be measured using the mini Asthma Quality of Life Questionnaire miniAQLQ at baseline and follow-up visits. Patients will record their weekly asthma medication intake using either paper or electronic diaries throughout the study. During the study, participants will attend routine follow-up visits where investigators will collect clinical assessments and questionnaire data. Researchers will monitor changes in asthma control, lung function parameters, medication use, and patient-reported outcomes up to 52 weeks after the first dose of benralizumab. The primary outcomes include changes in ACT scores and inhaled corticosteroid use, while secondary outcomes cover remission criteria, lung function, biomarkers, exacerbation rates, and quality of life measures.

Researchers are studying patients with colorectal liver metastases CRLM that have a mutation in the RAS gene. The trial aims to compare two surgical methods anatomical resection removal of the entire liver segment containing the tumor versus non-anatomical resection removal of the tumor with some healthy liver tissue, regardless of liver segments. This is the first prospective, randomized trial to evaluate the safety and effectiveness of using molecular information to guide surgery for this condition. Participants will be randomly assigned to one of two groups one undergoing anatomical resection and the other undergoing non-anatomical resection. These surgeries will be performed at specialized centers experienced in liver surgery. The study includes 220 patients and aims to see if the anatomical approach leads to better long-term outcomes compared to the non-anatomical approach. During the study, participants will be closely monitored for intrahepatic disease-free survival over 24 months. Researchers will also assess surgery-related factors such as blood loss, operating time, hospital and intensive care stays, complications, and liver function tests before and after surgery. Quality of life will be measured at 12 months. Safety and survival outcomes will be tracked up to 24 months to provide a complete view of both surgical methods.

Researchers are evaluating whether systematic pelvic and para-aortic lymphadenectomy LNE improves overall survival in patients with stage I or II endometrial cancer who have a high risk of recurrence. The trial also looks at how LNE affects disease-free survival, quality of life, complications, side effects, and the number of lymph nodes removed. A total of 640 patients with specific histological types and stages of endometrial cancer will take part in this study. Participants will be randomly assigned to one of two groups. In Arm A, patients will undergo the standard surgical procedure including total hysterectomy and bilateral salpingo-oophorectomy, with an omentectomy added for certain cancer types. In Arm B, patients will receive the same standard surgery plus systematic pelvic and para-aortic lymphadenectomy reaching up to the left renal vein. The study compares these two surgical approaches. Throughout the study, participants will be monitored for overall survival over 60 months. Researchers will also assess disease-free and disease-specific survival at multiple time points up to five years. Serious complications will be recorded during surgery and follow-up visits. Quality of life will be evaluated regularly using standardized questionnaires. The number of lymph nodes removed will be documented during surgery to support the evaluation of treatment impact and safety.

Researchers are studying patients with breast cancer, focusing on those with metastatic disease who typically have the poorest outlook. The trial aims to improve treatment decisions and quality of care by analyzing tumor characteristics. Although national guidelines recommend molecular reassessment of metastatic tumors, biopsies are rare due to invasiveness, so the study explores blood-based methods to assess tumor features and their relation to treatment outcomes and health economics. The study involves two groups about 3,500 patients with locally advanced or metastatic breast cancer receiving any line of treatment, and approximately 10,000 patients with early breast cancer undergoing neoadjuvant or adjuvant therapy regardless of regimen. Blood samples will be collected during routine blood draws to analyze tumor molecular characteristics and biomarkers for progression and survival. Participants will be followed with assessments including quality of life, therapy adherence, depression factors, and adverse events at study entry and regularly up to 60 months. The study will measure progression-free survival in metastatic breast cancer and disease-free survival in early breast cancer, along with overall survival and health economic outcomes. Results of molecular testing will be shared with patients at study end, providing comprehensive data to support improved breast cancer care.

Researchers are observing the real-world effects and patient experiences of trastuzumab deruxtecan T-DXd treatment in adults with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer. This prospective, non-interventional study takes place in multiple centers in Germany and aims to collect patient-reported outcomes along with safety and efficacy data during routine clinical practice. Approximately 800 patients will be enrolled, divided evenly between HER2-positive and HER2-lowultralow cohorts. Participants will receive T-DXd treatment as prescribed by their doctors according to the approved product guidelines SmPC. Treatment and visit schedules are determined by the treating physician and are not fixed by the study protocol. Patients will also be informed about using a digital healthcare application DiGA during the study. The study includes two cohorts based on HER2 status, both receiving T-DXd in routine care. During the study, participants will be followed to measure the time until their next treatment or death, assessed for up to 60 months from the first T-DXd dose. Quality of life will be evaluated using questionnaires at six months after baseline. Patient safety and treatment effects will be monitored through data collected in routine clinical visits. The total participation period may extend up to eight years, allowing for long-term observation of treatment outcomes in real-world settings.

Researchers are evaluating the effectiveness and safety of a subcutaneous treatment using one cycle of cladribine for patients with hairy cell leukemia who need treatment. This study focuses on patients who are either untreated or have been previously treated only with alpha-interferon. The goal is to determine the rate of complete remission and to assess whether a second cycle of treatment benefits those with a non-optimal response, defined as detectable residual disease or partial remission four months after the initial treatment. Participants receive cladribine at a dose of 0.14 mgkg body weight administered subcutaneously as a bolus injection once daily for five consecutive days. After four months, remission status is evaluated. Patients showing non-optimal response may be considered for a second treatment cycle. This phase 23 trial is designed to optimize therapy for hairy cell leukemia by closely monitoring treatment response and toxicity. During the study, participants undergo evaluations including disease status assessment through bone marrow and blood tests, with a focus on remission rates four months post-treatment. Researchers track complete remission rates and monitor for residual disease. Safety is also monitored by assessing potential toxicities. Participants general health status and other laboratory tests are reviewed to ensure eligibility and ongoing suitability for treatment throughout the study period, which spans several months with follow-up assessments.