Neumunster

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 large real-world observational study called LIVER-R to gather data on patients with hepatobiliary cancers, specifically unresectable hepatocellular carcinoma uHCC and advanced biliary tract cancers aBTC. The study aims to evaluate the outcomes of patients treated with durvalumab-based regimens, including combinations like STRIDE and durvalumab plus chemotherapy, as part of routine clinical practice or early access programs. This study is descriptive and noncomparative, focusing on real-world effectiveness and clinical characteristics across multiple countries and centers. The study will collect both primary data during patients routine visits and secondary data from medical records at enrollment and every 6 months. It includes a baseline period of up to 5 years before starting durvalumab treatment and a follow-up period lasting up to 3 years for uHCC patients and 2 years for aBTC patients. Data collected will cover treatment patterns, clinically significant events, concomitant medications, and various real-world clinical outcomes such as survival rates, progression-free survival, time to treatment progression, and recurrence-free survival. Participants will be adults diagnosed with hepatobiliary cancer and treated with durvalumab-based regimens as decided by their physicians. Researchers will monitor overall survival and other outcomes at multiple time points over the follow-up period. Data collection involves routine clinical visits, medical record review, and tracking of treatment and event timelines. The study will provide insights into the real-world use and outcomes of durvalumab therapies for these cancers, with continuous monitoring until death, withdrawal, loss to follow-up, or study completion.

Researchers are investigating the effects of additional chemotherapy treatment after surgery or ablation in patients with metastatic colorectal cancer whose tumor lesions have been definitively treated. This phase III, open-label, randomized, controlled trial aims to compare the effectiveness, quality of life, and safety of mFOLFOXIRImFOLFOX-6 chemotherapy against active follow-up without additional chemotherapy. The study also includes a translational research component to analyze tumor biopsies and blood samples for disease relapse markers. Patients are assigned randomly in a 21 ratio to receive either active chemotherapy mFOLFOXIRI, mFOLFOX6, FOLFIRI, or CAPOX for up to six months or structured follow-up without chemotherapy. Chemotherapy regimens involve intravenous infusions and oral medications administered in cycles every two or three weeks, with a maximum of 12 cycles for most treatments. After treatment or follow-up, participants continue with structured monitoring for up to five years. Participants undergo re-assessments every three months during the first two years, including CT or MRI scans of the thorax and abdomen, blood tests, and quality of life evaluations to detect disease relapse. After two years without relapse, follow-up intervals extend to every six months. The primary outcome measured is progression-free survival at 24 months, with secondary outcomes including overall survival, lesion control, adverse events, and quality of life monitored for up to five years following randomization.

Researchers are evaluating the impact of implantable cardioverter-defibrillators ICDs on patients who have survived a myocardial infarction heart attack and have a severely reduced left ventricular ejection fraction LVEF of 35% or less. This group is at increased risk of sudden cardiac death caused by dangerous heart rhythms. Past landmark trials showed ICDs improved survival, but advances in medical therapy have changed patient outcomes, prompting the need to reassess the benefits and risks of ICDs alongside current optimal treatments. In this randomized trial, participants receive optimal medical therapy OMT based on European Society of Cardiology guidelines for managing heart failure and chronic coronary syndromes. One group will also receive an ICD device, while the other group will not. The study compares outcomes between these two groups to determine if OMT without ICD is not worse than OMT with ICD in preventing death. The trial includes patients with symptomatic heart failure and reduced LVEF after a myocardial infarction. Participants will be followed over time with regular evaluations to monitor health and outcomes. Researchers will measure the time from randomization to death from any cause as the primary outcome, with additional assessments including cardiovascular death, sudden cardiac death, hospital readmissions, length of hospital stays, and quality of life over a year. The study is event-driven and expects to observe outcomes about 15 months after the last participant is enrolled. Safety and effectiveness of treatments will be carefully monitored throughout.

Researchers are observing adults with Chronic Lymphocytic Leukemia CLL who are receiving the drug venetoclax, either alone or combined with other medications such as rituximab, obinutuzumab, ibrutinib, or acalabrutinib. The study aims to understand how these treatments work in real-life settings, focusing on the effectiveness, costs related to health economics, and outcomes reported by the patients themselves. Participants receive venetoclax as prescribed by their doctors following local medical guidelines. They may receive it alone or alongside one of the other drugs mentioned. This study does not assign treatments but observes patients as they undergo therapy according to routine clinical practice across several countries. During the study, participants are monitored for their response to treatment, with the main focus on the best overall response rate within 12 months. Researchers collect data on health outcomes, costs, and patient experiences to better understand the impact of these therapies. The study spans several years, allowing long-term observation of treatment effects and outcomes.

Ulcerative colitis UC is a chronic inflammatory bowel disease causing inflammation and bleeding in the rectum and large intestine. This research aims to assess changes in disease activity in adults with moderate to severe UC who are treated with risankizumab in real-world clinical practice. The study will observe approximately 200 adult participants prescribed risankizumab by their physicians in Germany and Austria. Participants will receive risankizumab as prescribed by their doctors according to the approved local label and routine clinical care. The study does not introduce additional treatments or procedures beyond what is normally provided. Participants will be followed for up to 52 weeks while continuing their usual medication schedule. Throughout the study, participants will attend regular hospital or clinic visits as part of their routine care. Researchers will track the percentage of participants achieving symptomatic remission using the Partial Adapted Mayo Score over about 52 weeks. There is no expected added burden, and participants will receive standard monitoring and care during this period.