Herdecke

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

This research aims to observe the frequency of antibiotic prescriptions in children hospitalized with community-acquired pneumonia. It focuses on how doctors decide whether or not to use antibiotics in these cases, especially in a pediatric setting with a practice of limited antibiotic use. The study also records parent satisfaction regarding the treatment their child receives. Children admitted to the pediatric departments of the Filderklinik or Herdecke Community Hospital with pneumonia are enrolled consecutively. They are treated following the hospital's standard procedures, which may include either antibiotic treatment or no antibiotic treatment. The study monitors antibiotic treatment rates, disease severity, medical complications, and factors influencing physicians' decisions on antibiotic use. Throughout the hospitalization, researchers track antibiotic treatment rates and document parental satisfaction. Parents are contacted at least four weeks after discharge to check for any recurrence of pneumonia or readmission. The main outcome measure is the rate of antibiotic treatment during the hospital stay, which typically lasts an average of seven days.

Researchers are conducting a multinational clinical trial called LBL 2018 to study treatment approaches for children and adolescents newly diagnosed with lymphoblastic lymphoma. The trial aims to see if replacing prednisone with dexamethasone in induction therapy can reduce relapse involving the central nervous system (CNS) and if intensified treatment improves event-free survival in high-risk patients. Participants are grouped into high risk and standard risk categories based on disease characteristics to guide treatment and randomization. The study compares standard chemotherapy treatment using prednisone to an experimental approach using dexamethasone during induction. Patients in standard risk groups receive induction, consolidation, extra-compartment phases, reintensification (for some), and maintenance therapy over 24 months. High-risk patients can be randomized again after induction to receive either standard or intensified chemotherapy including additional PEG asparaginase and alternating high-risk courses. Patients with CNS involvement receive intensified intrathecal therapy and additional doses during maintenance without cranial irradiation. Participants undergo treatment phases lasting up to 24 months with follow-up for up to 7.25 years to monitor relapse rates and event-free survival. Evaluations include disease status, CNS involvement, and response to therapy. The trial collects pathology and genetic samples for risk stratification and monitors safety and treatment effects across multiple international centers. This comprehensive study seeks to improve outcomes while reducing CNS relapses in young patients with lymphoblastic lymphoma.

Researchers are collecting clinical data and biological samples from children and adults diagnosed with rare brain tumors such as medulloblastoma, ependymoma, pineal tumors, and choroid plexus tumors. This international registry, known as the I-HIT-MED, includes patients from Germany and other countries that meet ethical requirements. The goal is to improve understanding of these rare diseases and support better treatment recommendations and counseling through international cooperation. Participants in the registry contribute data including tumor characteristics from neuroradiology, pathology, and molecular biology, alongside details of their standard treatments. Biological specimens such as tumor tissue, cerebrospinal fluid, and blood may also be collected to study disease causes, factors affecting treatment response and survival, and potential targets for new therapies. The registry also evaluates quality assurance systems used in diagnosing and treating brain tumors. During the study, researchers will follow patients over time to monitor clinical courses, long-term outcomes, quality of survival, and neuropsychological effects. The data collected supports patient-centered research and collaboration with external partners. The registry includes patients diagnosed since January 1, 2012, and tracks event-free survival over 10 years, aiming to advance care and knowledge in these uncommon tumor types.

This research aims to explore the effects of music therapy on children with cancer and their families, focusing on improving parent-child interactions within a family setting. The study is a randomized controlled pilot trial evaluating how music therapy may enhance mutual attunement, nonverbal communication, and emotional parental responses, while also assessing impacts on quality of life and psychosocial and psychosomatic health. The study addresses a need for more clinical research on family interaction processes through music therapy in pediatric oncology. Participants are assigned to one of three groups: the first group receives interaction-focused music therapy involving both the child and significant family members; the second group receives music therapy involving only the child; and the third group is a waiting group that will receive the intervention after 10 weeks. All music therapy sessions are conducted by trained music therapists, focusing on the parent-child dyad or the child alone as applicable. Throughout the study, parent-child interaction is assessed before and during the 10th hour of intervention using a specialized music therapy assessment (APCI). Secondary outcomes, including quality of life and psychosocial measures, are evaluated using self-report questionnaires at multiple time points: before, after, and during follow-up. The study monitors the psychosocial functioning of the family system and hopes to provide evidence to support tailored family-centered care for children with cancer.

Researchers are studying pre- and perimenopausal women with estrogen- and/or progesterone-receptor-positive, HER2-negative early breast cancer who have an intermediate to high clinical risk but low genomic risk of recurrence based on MammaPrint4 testing. The study aims to understand the real-world use of ovarian function suppression (OFS) combined with endocrine therapy, with or without prior chemotherapy, and how secondary amenorrhea after chemotherapy might affect outcomes. It also focuses on treatment adherence and quality of life over time, given the importance of long-term endocrine treatment up to 10 years. The registry will follow patients receiving standard-of-care treatment, which may include endocrine therapy with or without ovarian function suppression, and potentially chemotherapy based on clinical decisions. Data on treatment choices, including the use of OFS and chemotherapy, will be collected along with tumor characteristics assessed by local pathology and genomic signatures. Quality of life assessments will be conducted at baseline and multiple time points up to five years, while treatment adherence and outcomes will be tracked over up to 10 years. Participants will provide baseline information including tumor and treatment details. Researchers will collect follow-up data on treatment adherence, quality of life using specific questionnaires, and disease outcomes such as the five-year distant recurrence-free interval. Monitoring will include hormonal status and clinical assessments to correlate treatment effects with genomic risk scores and clinical markers. The overall goal is to improve understanding of treatment patterns and outcomes in this specific breast cancer population under real-world conditions.

Researchers are studying acute lymphoblastic leukemia (ALL) in children and adolescents to improve treatment approaches. Recent genetic research shows ALL is a varied disease with different underlying mechanisms. This trial focuses on using new prognostic markers for better risk assessment and tests immunotherapy with the bispecific antibody blinatumomab as an alternative to some intensive chemotherapy in certain patients. It also evaluates the proteasome inhibitor bortezomib for patients with slow chemotherapy response and explores intensified consolidation chemotherapy in T-cell ALL patients to reduce relapse risk. Participants are assigned to risk groups based on leukemia type, genetics, and treatment response. The study tests four main questions through different randomizations comparing standard chemotherapy with added treatments: bortezomib during extended consolidation for early high-risk precursor B-cell ALL; blinatumomab immunotherapy replacing intensive chemotherapy courses for high-risk precursor B-cell ALL; blinatumomab after reintensification chemotherapy for intermediate-risk precursor B-cell ALL; and a longer, intensified consolidation phase for certain T-cell ALL patients. Some very high-risk patients may receive stem cell transplantation, and specific patients may get cranial irradiation. During the study, participants undergo comprehensive evaluations including genetic testing, bone marrow assessments, and minimal residual disease monitoring. Researchers track event-free survival and disease-free survival for up to 10 years from study start. They also monitor treatment safety, side effects, and overall survival. The trial enrolls patients under 18 years old recently diagnosed with ALL or related leukemias and follows individualized treatment plans based on risk and response.