Bremerhaven

Researchers are studying the real-world effectiveness, safety, and patient experience 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 patient compliance and quality of life among those treated with ribociclib, abemaciclib with endocrine therapy, or endocrine therapy alone. The goal is to understand treatment decisions and how these therapies perform in routine care settings. Participants receive treatment as prescribed by their doctors based on local guidelines and product information for ribociclib plus aromatase inhibitor with or without LHRH, abemaciclib with endocrine therapy plus or minus LHRH, or endocrine therapy alone plus or minus LHRH. There is no random treatment assignment since this is an observational study. Baseline data are collected shortly before or after treatment initiation depending on the cohort. During the study, patients will be followed for up to 36 months to monitor invasive disease-free survival and other health outcomes. Researchers will collect information on adverse events, treatment modifications, adherence measures, quality of life questionnaires, and socio-economic factors at various timepoints. This will provide insights into treatment tolerability, patient compliance, and overall impact on quality of life in a real-world setting.

Researchers are evaluating the real-world effectiveness of asciminib for adults with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase Ph CML-CP. This includes patients who are newly diagnosed or have been treated before with one tyrosine kinase inhibitor TKI. The study aims to gather information on how well asciminib works and its tolerability and safety compared to other TKIs used in routine care. The study includes three groups patients treated with asciminib, newly diagnosed patients treated with imatinib, and newly diagnosed patients treated with second-generation TKIs such as dasatinib, bosutinib, or nilotinib. Treatment decisions are made by the patients doctor as part of routine care, and treatment must start no more than 14 days before joining the study or after the baseline assessment. Patients are followed over time while receiving their assigned treatments. Participants will attend routine follow-up visits and complete questionnaires about their health and quality of life throughout the study. Researchers will measure the percentage of patients achieving a major molecular response at 12 months as the main outcome. Additional outcomes include treatment adherence, dose changes, interruptions, discontinuations, and quality of life scores. The study will continue until September 2030 to monitor safety and effectiveness in real-world settings.

Researchers are investigating the real-world use of encorafenib plus binimetinib for patients with unresectable advanced or metastatic melanoma that has a BRAF V600 mutation. This observational study focuses on documenting treatment effects, quality of life, safety, and tolerability after these drugs became commercially available in Germany, Austria, and Switzerland. The study specifically looks at patients treated in the first and second line settings after prior checkpoint inhibitor therapy. The study observes patients who are treated with encorafenib plus binimetinib according to the approved product guidelines. Participants may have started this treatment up to six months before joining the study or may begin treatment soon after enrollment. The study tracks treatment details, effectiveness, side effects, and patient-reported outcomes over a median treatment duration of about 12 months, with a total observation period of up to 90 months. Participants will be followed through regular documentation of their disease and treatment progress, including patient and disease profiles, treatment sequences, adverse events, and quality of life assessments using questionnaires. The main outcome measured is progression-free survival at 12 months after treatment start. Researchers will also evaluate treatment duration, interruptions, dose intensity, and physician satisfaction. Long-term safety and prognostic factors will be monitored throughout the observation period until study completion in September 2027.

Researchers are studying the clinical safety and effectiveness of the DERIVOae 2healae Embolisation Device used in treating intracranial aneurysms. This study is a prospective, single-arm, multicenter, open-label trial conducted in Germany to gather information on mid- and long-term clinical and angiographic outcomes. It aims to identify any risks and update the devices clinical evaluation to ensure its ongoing safety and performance after market approval. The study involves treating patients with the DERIVOae 2healae Embolisation Device as part of routine flow diversion therapy for intracranial aneurysms. Approximately 158 patients will be enrolled over 36 months across about 15 sites in Germany, with each patient followed for 12 months after treatment. Informed consent is obtained before or, in emergencies, shortly after the procedure. Data collected include technical success, safety, and clinical outcomes related to the devices use. Participants will be monitored through clinical evaluations at multiple time points including 6 weeks, 6 months, and 12 months after treatment. Researchers will assess primary safety, efficacy, and clinical endpoints, along with secondary outcomes measured immediately after treatment and at 12 months. Data are securely collected and monitored, with quality control steps ensuring accuracy. Results will be reported to ethics committees upon study completion.

Septic shock is a life-threatening condition caused by a harmful response to infection that leads to organ failure and high risk of death. This trial is designed to evaluate whether adding therapeutic plasma exchange TPE early in treatment can reduce organ damage and improve outcomes in patients with early septic shock. The study addresses a critical need for more specific treatments beyond current supportive care. Participants will be randomly assigned to receive either one or two sessions of TPE using donor fresh frozen plasma within the first day after randomization or standard care without TPE. The first TPE session occurs within 6 hours and lasts about 2 to 3 hours, with a second session possible if high doses of vasopressors are still needed. Plasma is replaced at a fixed volume ratio to the patients plasma. Anticoagulants like heparin or citrate may be used during TPE. During the study, researchers will monitor participants for 28 days to assess survival, organ function, and need for organ support. They will collect detailed data on organ failure scores, heart and lung function, blood tests, infections, and length of hospital stay. Safety and treatment effects will be closely followed up to 90 days after randomization. The overall study duration varies per patient based on recovery and hospital discharge.

Researchers are investigating treatments for triple-negative breast cancer TNBC, a type of breast cancer known for its aggressive nature, poor outlook, and diverse molecular features. The study focuses on patients with lower-risk, early-stage TNBC, where current chemotherapy standards exist but optimal treatment strategies and durations remain unclear. This trial aims to compare neoadjuvant therapies to improve outcomes in this common patient group, addressing a significant medical need in Western Europe and the USA. The trial compares two neoadjuvant treatment options sacituzumab govitecan SG alone versus SG combined with pembrolizumab PEM. Both treatments are given intravenously over 12 weeks in four cycles. Depending on the patients response after 12 weeks, some may receive additional cycles before surgery. After surgery, further treatment depends on the pathological response, with some patients receiving chemotherapy if residual cancer remains. The study evaluates if these regimens can achieve high rates of complete remission with a better safety profile compared to standard chemotherapy. Participants will undergo regular clinical assessments, including pathology reviews and imaging, throughout treatment and follow-up. Researchers will monitor responses at surgery, invasive disease-free survival up to three years, and overall survival over six years. Quality of life is also assessed through questionnaires during and after treatment. The trial involves careful safety monitoring and long-term follow-up to understand the effects of these therapies on disease recurrence and patient well-being.

Researchers are evaluating durvalumab-based treatments in patients with hepatobiliary cancers, including unresectable hepatocellular carcinoma uHCC and advanced biliary tract cancers aBTC. This observational study aims to gather real-world data on how these treatments perform outside of clinical trials, focusing on overall survival and other clinical outcomes. The research includes patients treated as part of routine care or through early access programs, reflecting diverse international settings. The study will collect both primary data during patients routine visits and secondary data from medical records at enrollment and every six months. Data collection covers a baseline period of up to five years before starting durvalumab-based therapy, with follow-up lasting up to three years for uHCC patients and two years for aBTC patients. The study observes treatment patterns, clinical events, and outcomes such as progression-free survival and time to treatment progression without testing any specific hypotheses. Participants will be monitored through regular collection of clinical information, treatment details, and significant events related to their care. Researchers will assess survival rates at various intervals up to three years and measure other outcomes including treatment duration, recurrence-free survival, and time to next treatment. The studys descriptive analyses will help understand the real-world effectiveness and safety of durvalumab-based regimens in hepatobiliary cancer populations across multiple countries.

Researchers are studying pre- and perimenopausal women with estrogen- andor progesterone-receptor-positive, HER2-negative early breast cancer who have intermediate to high clinical risk but low genomic risk of recurrence according to MammaPrint. This observational registry aims to understand the real-world use of ovarian function suppression OFS combined with endocrine therapy, especially in relation to chemotherapy use and secondary amenorrhea. The study also examines the impact of various clinical and genomic factors on treatment outcomes and quality of life. Participants receive standard-of-care treatments including endocrine therapy with or without ovarian function suppression and possibly chemotherapy, based on individual risk assessments. The registry collects data on treatment paths, adherence to therapy, and the use of ovarian function suppression over time. Quality of life is assessed regularly using specific questionnaires at multiple time points up to 5 years, and treatment adherence is monitored for up to 10 years. Throughout the study, researchers gather detailed baseline, treatment, and relapse information. They measure outcomes such as 5-year distant recurrence-free interval and monitor quality of life through validated questionnaires at intervals ranging from every 3 months in the first year to yearly up to 5 years. Long-term follow-up includes adherence tracking and evaluation of molecular and pathological markers over 10 years, providing insights into treatment effectiveness and patient well-being in real-world conditions.

Researchers are evaluating patient-reported outcomes and real-world data on the use of trastuzumab deruxtecan T-DXd in adults with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer. This observational study focuses on the effectiveness and safety of T-DXd as used in routine clinical practice in Germany, including how patients respond to the treatment over time. The study is non-interventional and involves patients receiving T-DXd according to approved guidelines. The study includes two groups one with patients having HER2-positive tumors and another with patients having HER2-low or HER2-ultralow tumors. All patients receive T-DXd treatment as recommended by the products summary of characteristics, and all medical decisions including treatment schedules are made by the treating physicians. Participants will also be informed about the use of a digital healthcare application DiGA to support their care. Participants will be observed for up to 60 months to track the time until the next treatment or death, whichever occurs first. Patient quality of life will be assessed six months after starting treatment using specific questionnaires FACT-B and FACT-G. Other data collected will include safety and efficacy outcomes reported during regular clinical visits. The study aims to enroll approximately 800 patients, with about 400 in each cohort, and will continue until the end of 2031.

This research aims to assess the effectiveness and safety of permanently placing a self-expandable CREDO4 heal Stent in patients with symptomatic intracranial artery narrowing, following unsuccessful attempts to reopen blocked large blood vessels in the brain caused by acute ischemic stroke. The study focuses on cases where mechanical thrombectomy has failed to restore blood flow, targeting arteries in either the front or back circulation of the brain. Participants will receive rescue stenting using the CREDO4 heal Stent combined with the NeuroSpeed PTA Balloon Catheter after at least one unsuccessful mechanical recanalization attempt with devices such as stent retrievers or aspiration. Treatment is intended for patients with suitable intracranial artery stenosis and symptoms starting less than 24 hours before the procedure. The stenting procedure is performed according to specific instructions for use and physician assessment. During the study, researchers will evaluate technical success by the proportion of patients achieving good blood flow eTICI 2b-3 immediately after treatment and clinical success by the proportion of patients with good functional outcome mRS 0-2 at about 90 days post-procedure. Participants will be monitored for stroke symptom changes and disability levels, with assessments at the procedures end and follow-up visits to measure recovery and safety over time.