Flensburg

Researchers are evaluating whether using an automated Carbon Dioxide CO2 injection system during infrainguinal peripheral vascular interventions PVI can reduce major adverse kidney events within 90 days in patients at moderately increased risk for contrast-associated acute kidney injury CA-AKI. This Phase 3 randomized controlled trial compares a CO2-based contrast medium sparing strategy to the standard use of iodinated contrast media in patients with peripheral vascular and kidney diseases. Participants are randomly assigned to one of two groups. The intervention group receives PVI using an automated CO2 injection system as the primary contrast agent, with iodinated contrast media available as a backup if image quality is insufficient or if the patient cannot tolerate CO2 angiography. The control group undergoes routine PVI using iodinated contrast media according to local standards, avoiding high-osmolar contrast agents. All patients are followed for up to 12 months after their procedure. During the study, participants undergo the planned PVI procedure with either contrast method. Researchers carefully record the amount and reasons for any iodinated contrast media used in the CO2 group. Patients are monitored for kidney-related outcomes, focusing on major adverse kidney events up to 90 days after the intervention. The trial includes ongoing follow-up assessments to evaluate safety and effectiveness over one year.

Researchers are evaluating the efficacy and safety of rilvegostomig compared to pembrolizumab monotherapy as the first-line treatment for patients with metastatic non-small cell lung cancer mNSCLC whose tumors express high levels of PD-L1. This Phase III, randomized, double-blind, multicenter global study focuses on patients with mNSCLC without certain genetic mutations who are suitable for this treatment approach. Participants are randomly assigned to receive either rilvegostomig or pembrolizumab intravenously on Day 1 of each 21-day cycle. The study compares these two drugs over repeated treatment cycles as first-line therapy. Both treatments are biological agents given by infusion, and the study is designed to monitor their effects over up to approximately five years. During the trial, participants will undergo regular assessments including physical exams, imaging scans such as CT or MRI to measure tumor lesions, and laboratory tests to evaluate organ function. Researchers will closely monitor overall survival, progression-free survival, treatment response, duration of response, and patient-reported outcomes on physical functioning and quality of life. Safety and immunogenicity of rilvegostomig will also be evaluated. Participants are followed and assessed for up to five years to gather comprehensive data on treatment effects and long-term outcomes.

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 conducting a prospective observational study to examine asthma control, health-related quality of life HRQL, lung function, and asthma medication use in patients with severe eosinophilic asthma treated with benralizumab in routine clinical practice settings in Germany. The study aims to gather real-world evidence on these patients over a 52-week period. Participants will be treated with benralizumab as part of their standard care, and no additional treatment will be assigned by the study. Asthma control will be assessed using the Asthma Control Test ACT and the Asthma Impairment and Risk Questionnaire AIRQae at various timepoints. Health-related quality of life will be measured using the mini Asthma Quality of Life Questionnaire miniAQLQ at baseline and follow-up visits. Patients will record their weekly asthma medication intake using either paper or electronic diaries throughout the study. During the study, participants will attend routine follow-up visits where investigators will collect clinical assessments and questionnaire data. Researchers will monitor changes in asthma control, lung function parameters, medication use, and patient-reported outcomes up to 52 weeks after the first dose of benralizumab. The primary outcomes include changes in ACT scores and inhaled corticosteroid use, while secondary outcomes cover remission criteria, lung function, biomarkers, exacerbation rates, and quality of life measures.

Researchers are evaluating the combination of adagrasib, pembrolizumab, and platinum-doublet chemotherapy compared to placebo plus pembrolizumab and platinum-doublet chemotherapy in adults with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer NSCLC carrying the KRAS G12C mutation. This Phase 3 trial aims to assess the efficacy, safety, and tolerability of these treatment combinations in this specific patient group. Participants will receive either adagrasib plus pembrolizumab combined with platinum-doublet chemotherapy or placebo plus pembrolizumab and platinum-doublet chemotherapy. Treatments involve specified doses administered on scheduled days, with the chemotherapy consisting of carboplatin or cisplatin along with pemetrexed. Participants are randomly assigned to one of the two study groups and treatments are blinded to ensure unbiased assessment. Throughout the study, participants will undergo regular evaluations including imaging scans to measure tumor response and progression-free survival, as well as assessments of overall survival. Safety is closely monitored by recording adverse events for up to 90 days after the last dose. Quality of life and symptom assessments are also conducted using validated questionnaires. The study duration includes follow-up for up to seven years to gather comprehensive data on treatment outcomes and participant health.

Researchers are studying metastatic colorectal carcinoma mCRC patients who have a specific BRAFV600E mutation, which is linked to poorer outcomes compared to those without it. This mutation leads to shorter survival times after initial treatments, prompting the need for new therapy combinations. This research aims to observe how the drugs encorafenib and cetuximab work together in real-world settings for patients who have already received prior systemic therapies. This non-interventional, prospective, longitudinal study focuses on patients treated with encorafenib plus cetuximab following prior systemic therapy. The study collects data on treatment effectiveness, safety, and quality of life among a broader patient population in Germany, Austria, and Switzerland. Patients may have started treatment up to three months before joining the study or plan to start soon, and the study observes their outcomes without influencing treatment decisions. Participants will be monitored through data collection on their disease and treatment profiles, including patient and physician assessments, adverse events, and treatment details. The main outcome measured is overall survival at 12 months after starting treatment. Additional information gathered includes treatment duration, dose intensity, interruptions, and patient-reported quality of life using questionnaires. Safety and tolerability are also evaluated throughout treatment, with follow-up averaging nine months.

Researchers are evaluating whether using a reminder app alongside standard skin care helps reduce the occurrence of moderate to severe radiation dermatitis in female breast cancer patients receiving adjuvant radiotherapy. This multinational, randomized trial compares standard skin care alone to standard skin care supported by an app that reminds patients to perform skin care four times daily. The study also looks at pain levels, patient satisfaction with the app, and how the app affects the use of health technology, especially in different age groups. Participants receive radiotherapy over about three to four weeks using hypo-fractionated doses, with some patients receiving additional radiation boosts based on age and risk factors. All patients perform standard skin care, which includes applying fatty cream with urea and possibly mometasone furoate cream in the app-supported group, patients also receive reminders and guidance through the app. The app allows patients to set notification schedules, postpone care reminders, and earn points for adherence. Patients in the app group will complete a questionnaire on their satisfaction and the apps impact at the end of treatment. During the study, radiation dermatitis is assessed weekly and at the end of radiotherapy by trained observers. Pain scores and patient satisfaction are also measured throughout the approximately four-week treatment period. Data on the apps use and support benefits are collected from the app group. The study includes 268 female patients aged 18 years and older with invasive breast cancer, who can use a smartphone and provide consent. Safety and compliance are monitored, with statistical analysis planned to compare outcomes between groups.

This research aims to gather detailed data and biomaterials from adults diagnosed with Acute Lymphoblastic Leukemia ALL and related diseases, including certain types of Leukemia and Non-Hodgkins Lymphoma. The registry supports ALL research and quality assurance by collecting information regardless of whether patients participate in clinical trials. The study is observational and involves adults diagnosed and treated under ALL protocols. Participants include adults aged 18 and older with ALL subtypes, other leukemias treated according to ALL protocols, and specific subtypes of Non-Hodgkins Lymphoma treated under B-ALL protocols. The study collects data prospectively on diagnosis, treatment, and outcomes, along with biomaterials related to these conditions. Participants provide information during routine clinical care and follow-up visits for up to 10 years. Data collected includes survival rates, remission status assessed by various methods including PET scans, relapse rates, quality of life questionnaires, and monitoring of toxicities and comorbidities. The study tracks overall survival and other outcomes over long-term follow-up to support research and quality assurance in adult ALL and related diseases.

Researchers are evaluating maintenance therapies for patients with newly diagnosed multiple myeloma who have undergone induction therapy and autologous stem cell transplantation ASCT. The study compares a combination of iberdomide and isatuximab with iberdomide alone to determine if adding isatuximab reduces measurable myeloma cells in the bone marrow after two years. This is a multicenter, randomized, open phase III trial building on prior treatments from the GMMG-HD8DSMM XIX trial or similar regimens. Participants are randomly assigned to one of two groups. One group receives oral iberdomide alone for 39 cycles, each lasting 29 days, with dexamethasone added during the first cycle. The other group receives the same iberdomide regimen plus subcutaneous isatuximab injections using a wearable injector system, with dexamethasone also given in the first cycle. Treatment continues for up to 36 months. Randomization considers factors like minimal residual disease MRD status and the number of transplantations. During the study, participants will undergo bone marrow assessments to measure MRD using next-generation flow cytometry. Researchers will monitor progression-free survival, overall survival, response rates, and quality of life using validated questionnaires. Safety and treatment effects will be followed for up to five years after randomization. Participants will have regular evaluations including laboratory tests and clinical assessments throughout the maintenance period and follow-up.

Researchers are investigating treatments for adults diagnosed with acute myeloid leukemia AML or MDSAML that have a mutation in the IDH1 gene and who cannot undergo intensive chemotherapy. The study evaluates whether adding the drug venetoclax to the existing standard treatment of ivosidenib and azacitidine improves patient outcomes compared to a placebo. The safety and effectiveness of venetoclax are key focuses of this phase 3 trial. Participants receive either venetoclax or a placebo alongside ivosidenib and azacitidine. Treatments are given in continuous 28-day cycles and continue until disease relapse, progression, unacceptable side effects, death, withdrawal, or other protocol-defined reasons for stopping. The trial uses a triple-blind, randomized design to fairly compare the two treatment groups. During the study, researchers will monitor event-free survival as the primary outcome, assessing patients for signs of disease control or progression up to 12 months after the last patient is included. Secondary measures include overall survival, response rates, transfusion independence, and the duration and timing of responses. Participant involvement includes regular assessments, blood tests, and monitoring for side effects throughout the treatment period and follow-up.