Mulheim An Der Ruhr

Researchers are evaluating various approved injectable and oral disease-modifying treatments (DMTs) in patients with relapsing multiple sclerosis (RMS) in Germany. This observational, non-interventional, multicenter, open-label study collects primary data prospectively over up to four years, alongside retrospective data. The study captures medical history, disease duration, laboratory values, disability scores (EDSS), MRI results, and relapse information to provide real-world insights into treatment use and outcomes. Patients receiving routine medical treatment with any approved injectable or selected oral DMTs—including ofatumumab, glatiramer acetate, interferon 21, teriflunomide, dimethyl fumarate, and diroximel fumarate—are enrolled without treatment allocation by the study. Two cohorts are observed: one treated primarily with injectable DMTs and another with injectable or oral DMTs. The core study period lasts about two years, with an optional extension providing an additional two years of observation, totaling up to four years. Follow-up visits and monitoring happen at the investigator's discretion and may include telemedicine. During the study, participants provide data through questionnaires and electronic case report forms. Routine clinical care procedures, such as diagnostic tests and monitoring, continue as usual. Researchers measure the proportion of patients continuing their baseline treatment at 24 months and collect ongoing clinical and imaging data. The study emphasizes real-world treatment patterns, safety, and disease activity over the extended follow-up period.

Researchers are studying metastatic colorectal carcinoma (mCRC) patients whose tumors have a BRAFV600E mutation, which is known to have a poorer outlook compared to non-mutated cases. Standard treatments after the first therapy have shown limited success, with low response rates and short survival times. This study aims to understand how the combination of encorafenib and cetuximab works in real-world settings, focusing on effectiveness, quality of life, safety, and tolerability in German, Austrian, and Swiss patients who have already received prior therapies. Participants will receive encorafenib combined with cetuximab, treatments that target specific cancer mutations. This study is observational and non-interventional, meaning it records how patients respond to these drugs in routine care without altering their treatment. The study allows initial retrospective data collection and will follow patients longitudinally to gather comprehensive information about their experiences with the therapy. During the study, patients will be monitored for overall survival twelve months after starting treatment. Researchers will assess how well the treatment controls the cancer, side effects experienced, and patients' quality of life. Data will be collected from medical records and patient reports in regular clinical care, providing insights into the real-life use and impact of encorafenib and cetuximab for this patient group.

This research aims to gather real-world information on using intravascular lithotripsy (IVL) with the Shockwave IVL system to treat calcified lesions in the femoropopliteal and crural arteries of patients with chronic limb-threatening ischemia (CLTI). The main goal is to understand how effective IVL is in helping wounds heal and avoiding amputations. The study also looks at how well the treatment restores blood flow immediately, its safety, and its effect on patients' quality of life. Participants receive treatment with the Shockwave Medical IVL System, a comprehensive device that includes a generator, connector cable, and a single-use catheter with an integrated balloon designed to break up artery calcification. The study is observational and collects data on patients who undergo this treatment for their calcified arterial lesions. During the study, researchers will monitor wound healing and whether participants avoid amputation over 12 months. They will also assess how well the blood vessels open after treatment and track safety and quality of life outcomes. Participants will be followed to collect this information over the course of a year to understand the impacts of IVL treatment for CLTI.

Researchers are evaluating the effects of stopping CDK4/6 inhibitors in women with metastatic hormone receptor-positive, HER2-negative breast cancer who have had long-lasting disease control. This phase II, low-intervention trial aims to assess whether patients can maintain stable disease after discontinuing CDK4/6 inhibitors following at least 12 months of combined treatment with endocrine therapy. The study focuses on long-term disease stabilization and progression-free survival 12 months after randomization. Participants are assigned to either continue or discontinue CDK4/6 inhibitors such as Palbociclib or Abemaciclib while maintaining endocrine therapy. The study is open-label and multicenter, allowing close observation of treatment effects. During the trial, patients will be monitored to see if disease control persists after stopping the CDK4/6 inhibitor treatment. Throughout the study, participants undergo regular assessments including evaluations of disease status and safety monitoring. Researchers will track progression-free survival at 12 months after randomization as the primary outcome. The trial includes detailed monitoring of participants' health and treatment responses to understand the impact of discontinuing CDK4/6 inhibitors in this patient population.

Researchers are evaluating the real-world clinical use and outcomes of men with metastatic castration-resistant prostate cancer (mCRPC) who are treated with a combination of olaparib and abiraterone. The study focuses on patients who have either not previously received next-generation hormonal agents (NHA-naive) or who have been exposed to NHAs before starting this combined treatment. This prospective observational study aims to describe patient demographics, clinical characteristics, and treatments before and after olaparib plus abiraterone therapy. The study will enroll patients who have started treatment with olaparib plus abiraterone after the study site became active. It will follow patients for up to 2 years to collect data on their treatment experience. No experimental interventions are administered as part of the study; instead, it observes patients receiving standard treatment in routine clinical settings. Participants will be monitored from the start of olaparib treatment until one year after the last patient enrolls. Researchers will collect clinical data to assess treatment discontinuation times and overall outcomes during this period. The study will capture information on patients’ clinical progress and any subsequent therapies, providing insights into the real-world effectiveness and use of this treatment combination.

Researchers are evaluating how well the drug cabozantinib works and how safe it is for adults with neuroendocrine tumors (NETs), a type of cancer that can occur in various parts of the body. This study focuses on participants whose cancer has continued to grow despite having received at least one previous systemic treatment. The study is conducted in regular hospitals and clinics in Germany and Austria, involving about 150 participants taking cabozantinib as part of their usual care. The study is observational, meaning no extra tests or procedures are performed beyond routine medical care. Participants receive cabozantinib treatment as decided by their doctors before joining the study. Researchers collect information from regular medical visits, tests, and scans to monitor how the cancer responds to the treatment and how long participants stay on cabozantinib. They also track any side effects and assess the impact of treatment on participants' quality of life. Participants are involved by attending their usual medical appointments where doctors gather data on their health and treatment progress. The main outcome measured is the Disease Control Rate (DCR) at 6 months. Safety is monitored through observations of side effects during regular care. The study duration depends on each participant's treatment course, with data collected throughout their time on cabozantinib.