Rudersdorf Bei Berlin

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 studying adults with Chronic Inflammatory Demyelinating Polyradiculoneuropathy CIDP to understand why they choose certain treatments, particularly switching to HyQvia, and how satisfied they are with HyQvia and their previous therapies. The study also explores how CIDP affects work productivity and daily activities, as well as the signs and symptoms of CIDP. The research collects information on medical problems or side effects during HyQvia treatment, its effectiveness, and healthcare needs such as emergency or hospital visits. Participants are divided into two groups those who plan to switch to HyQvia within six weeks after joining the study and those who have already switched within six weeks before joining. Data will be collected over 12 months through interviews, medical record reviews, and questionnaires. Treatment follows the doctors usual clinical care and is not controlled by the study. During the study, participants will complete questionnaires about their treatment preferences, satisfaction, quality of life, disability, and work productivity at the start and throughout the 12 months. Researchers will monitor any adverse effects and changes in physical strength and disability scores. Healthcare use and treatment details will be tracked regularly to understand the real-world use and impact of HyQvia in managing CIDP.

Researchers are evaluating how Digital Navigators DN can assist general practitioners, outpatient psychiatrists, psychologists, and their patients in using digital mental health apps DiGAs and integrating them into treatment. The study aims to understand the opportunities and barriers to implementing DNs, acceptance and expectations towards them, and their effects on patients psychological health and digital literacy. Medical assistants and other medical team employees receive training to become Digital Navigators. These trained navigators support treatment teams in selecting and integrating suitable mental health apps and accompany patients for 12 weeks to help them find and use an appropriate app. The study includes a preliminary phase with interviews and focus groups, followed by DN training and a 12-week intervention period with 48 patients. Participants undergo assessments before and after the 12-week intervention to measure digital health literacy, acceptance and expectations of Digital Navigators, psychological health, and digital competence. Data collection involves interviews, focus groups, and validated scales to evaluate symptom severity and treatment effects. The study also evaluates implementation barriers and aims to establish accredited DN training for sustainable use.

The German Dementia Registry DEMREG is a large-scale national study focused on collecting real-world data from patients diagnosed with Subjective Cognitive Decline SCD, Mild Cognitive Impairment MCI, and early dementia of various types in Germany. The study aims to follow patients over time to better understand the natural progression of dementia and differences between types such as Alzheimers and other dementias. It provides a clinical platform for research that aligns with current diagnostic and treatment guidelines. This is an observational registry study where no treatments are given as part of the research. Instead, patients usual care and medications are documented. Data are collected through patient visits using questionnaires and tests related to early dementia. The registry collects biomarker data, including cerebrospinal fluid and imaging markers, and follows patients annually for as long as possible to track changes over time. Participants will have baseline and yearly follow-up visits where clinical data, biomarker results, and questionnaire information are gathered. The study monitors the natural course of dementia and changes in biomarkers, aiming to inform future diagnostic criteria and treatment approaches. Participation involves consenting patients and optionally family members who are involved in the patients care. The registry is ongoing with long-term follow-up planned.

Researchers are evaluating RAY121, an inhibitor of the classical complement pathway, in a Phase 1b basket trial involving patients with various immunological diseases including antiphospholipid syndrome, bullous pemphigoid, Behets syndrome, dermatomyositis, immune-mediated necrotizing myopathy, and immune thrombocytopenia. This study aims to investigate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of multiple doses of RAY121 in these patient populations. All enrolled patients will receive multiple doses of RAY121 administered by injection. The study is designed as a single-group trial where participants receive the experimental treatment without comparison to placebo or other interventions. Treatment monitoring and assessments will continue up to 32 weeks following the baseline visit to evaluate the effects and behavior of the drug in the body. Participants will be involved in regular assessments including monitoring for adverse events, measurement of drug concentration and activity, complement pathway activity, and antibody formation against RAY121 from baseline through week 32. The study includes safety evaluations and collection of pharmacokinetic and pharmacodynamic data to understand how the drug works and is tolerated over time. The total participation duration may last up to 32 weeks with ongoing monitoring throughout this period.

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.