Herdecke

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 observing how often antibiotics are prescribed to children hospitalized with community-acquired pneumonia and how doctors decide whether antibiotics are needed. The study also records parental satisfaction with the treatment process. It focuses on a pediatric department known for cautious antibiotic use. This observational study aims to understand treatment patterns and outcomes without altering standard care. Children with non-severe community-acquired pneumonia and fever will be followed either with antibiotic treatment or without antibiotics, depending on the attending physicians decision according to hospital procedures. These two groups include children managed with antibiotics and those managed without. Treatment follows the hospitals standard operating procedures without experimental interventions. During the hospital stay, which averages about 7 days, researchers will track antibiotic use rates, disease severity, medical complications, oxygen use, medication use, and hospital stay duration. Parents will be contacted at least 4 weeks after discharge to check for pneumonia recurrence or readmission. Parental satisfaction with care during hospitalization will also be assessed.

This research aims to improve treatment for children and adolescents newly diagnosed with lymphoblastic lymphoma. The trial is a large, international, randomized clinical study involving multiple countries and specialized centers. It focuses on whether using dexamethasone instead of prednisone during the induction phase can reduce relapses in the central nervous system CNS, and for high-risk patients, whether an intensified treatment improves event-free survival compared to standard therapy. Participants are grouped by risk level based on disease characteristics like CNS involvement and genetic markers. All patients first receive a prednisone prephase, then are randomized to either standard induction with prednisone or experimental induction with dexamethasone. Treatment phases include consolidation, extra-compartment phases adjusted by risk group, reintensification for some groups, and maintenance therapy lasting up to 24 months. Patients with CNS involvement receive intensified intrathecal therapy without cranial irradiation. High-risk patients may undergo a second randomization to receive either standard or intensified treatment during later phases. During the study, patients undergo various treatments including chemotherapy drugs such as cyclophosphamide, methotrexate, and PEG asparaginase. Researchers monitor disease relapse involving the CNS and measure event-free survival over a maximum of 7.25 years. Secondary assessments include overall survival, treatment-related toxicity and mortality, adverse events, and molecular markers. The trial involves ongoing follow-up for safety and effectiveness outcomes throughout the study period, which can last several years.

Researchers are collecting detailed clinical and biological data from children and adults diagnosed with rare brain tumors, including medulloblastoma, ependymoma, pineal tumors, and choroid plexus tumors. This international registry aims to improve understanding of these rare diseases, support quality assurance networks, and enhance collaboration across countries. The registry focuses on patients treated outside of clinical trials to help establish standard treatment recommendations and counseling. Participants provide information on tumor characteristics, treatment details, and biological samples such as tumor tissue, cerebrospinal fluid, and blood. The registry evaluates disease causes, molecular risk factors, and potential targets for future drug treatments. It also monitors the use of quality assurance systems during diagnosis and treatment and supports long-term follow-up studies on survival, neuropsychology, and patient-centered outcomes. During participation, patients contribute data over time, allowing researchers to track clinical courses and treatment responses. The registry assesses long-term outcomes including event-free survival, relapse patterns, and overall survival for up to 10 years. Ethical approval and informed consent are required, ensuring data is collected responsibly. This ongoing observational study provides valuable insights to improve care for patients with these rare brain tumors.

Researchers are investigating the real-world use and effects of ovarian function suppression OFS combined with endocrine therapy in pre- and perimenopausal women with breast cancer who have low genomic risk according to MammaPrint testing. The study aims to understand differences in treatment outcomes based on menopausal status, chemotherapy use, and endocrine therapies, with a focus on adherence and quality of life over time. This observational registry will collect data to provide insights into treatment paths, outcomes, and factors influencing prognosis in these patients. Participants receive standard-of-care endocrine therapy with or without ovarian suppression and may have received chemotherapy based on clinical decisions and genomic risk assessments. The registry observes various treatment approaches in a real-world setting, including management of ovarian function, and follows patients for up to 10 years. Quality of life assessments occur regularly during the first five years, and treatment adherence is monitored throughout the study period. During the study, participants medical data including baseline characteristics, treatment details, relapse information, and quality of life questionnaires will be collected at multiple time points. Researchers will evaluate outcomes such as distant recurrence-free interval, disease-free survival, overall survival, and endocrine response over 5 to 10 years. The long-term follow-up allows for detailed monitoring of treatment adherence and correlation of genomic and clinicopathological markers with patient outcomes.

Researchers are studying acute lymphoblastic leukemia ALL in children and adolescents, recognizing it as a diverse disease with complex genetic features. The study aims to improve treatment by using more precise risk assessments and testing immunotherapy as an alternative to intensive chemotherapy, especially for patients at high risk of relapse. It also explores targeted therapy to overcome chemotherapy resistance and evaluates extended chemotherapy for T-cell ALL patients with slower treatment responses. The study divides patients into risk groups based on leukemia type, genetics, and treatment response, then tests different experimental treatments alongside standard chemotherapy. These include the proteasome inhibitor bortezomib during consolidation for high-risk B-cell ALL, immunotherapy with blinatumomab replacing intensive chemotherapy in high-risk patients, and blinatumomab for intermediate-risk patients. T-cell ALL patients receive extended consolidation chemotherapy to reduce relapse risk. Participants undergo a series of treatment phases including induction, consolidation, extra-compartment, reinduction, and maintenance therapy lasting up to two years after diagnosis. Treatments include various chemotherapy drugs and immunotherapy cycles depending on the assigned group. Researchers monitor outcomes such as event-free and disease-free survival over up to ten years, along with treatment toxicity and minimal residual disease response. Some high-risk patients may receive stem cell transplants or cranial irradiation as part of their treatment plan.