Heidenheim An Der Brenz

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 evaluating the real-world effectiveness of asciminib in adult patients with Philadelphia chromosome-positive chronic myeloid leukemia in the chronic phase Ph CML-CP. This observational study compares patients who are newly diagnosed or previously treated with one ATP-competitive tyrosine kinase inhibitor TKI to those treated with other TKIs. The study aims to assess tolerability, safety, and molecular response outcomes in routine clinical care. Participants are grouped into cohorts based on their treatment those receiving asciminib, those newly diagnosed treated with imatinib, and those newly diagnosed treated with second-generation TKIs such as dasatinib, bosutinib, or nilotinib. Treatment decisions are made by physicians prior to enrollment, and treatment must not have started more than 14 days before joining the study. The study follows patients over time to document treatment patterns, dose changes, interruptions, and discontinuations. Participants will attend routine follow-up visits and complete patient-reported outcome questionnaires assessing medication adherence, quality of life, and work productivity at multiple time points up to 24 months. Researchers will measure major molecular response at 12 months as the primary outcome and evaluate various secondary molecular responses, reasons for treatment changes, and quality of life scores. The study duration extends through September 2030, allowing long-term observation of treatment effectiveness and safety.

Immune thrombocytopenia ITP is a rare blood disorder caused by an autoimmune condition that reduces platelet counts, increasing the risk of bleeding or prolonged bleeding. New treatments for ITP have emerged recently, but existing clinical studies are limited in their applicability to everyday patient care due to strict criteria. This registry aims to collect real-world clinical data and biospecimens from patients with various types of ITP to improve understanding of diagnosis, therapy, and patient outcomes in routine treatment. The registry includes patients diagnosed with primary or secondary ITP who consent to participate. Data collection occurs at defined points in the disease course either prospectively or retrospectively up to 12 months after diagnosis, provided continuous documentation is available. Biospecimens are collected and stored systematically to support research. Clinical information collected includes disease characteristics, treatment types, complications, quality of life, fatigue scores, and survival data over a follow-up period of up to 5 years. Participants provide clinical data and biosamples at enrollment, then again at 6 months and annually for up to 5 years. Assessments include platelet counts, bleeding and thromboembolic events, laboratory markers such as specific antibodies, and patient-reported outcomes like quality of life and fatigue. The study gathers epidemiological data on incidence, age, sex distribution, causes of ITP, treatment received, and remission status. The registry helps advance knowledge about ITP through long-term monitoring and standardized data collection.

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 observing the real-world effects and patient experiences of trastuzumab deruxtecan T-DXd treatment in adults with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer. This prospective, non-interventional study takes place in multiple centers in Germany and aims to collect patient-reported outcomes along with safety and efficacy data during routine clinical practice. Approximately 800 patients will be enrolled, divided evenly between HER2-positive and HER2-lowultralow cohorts. Participants will receive T-DXd treatment as prescribed by their doctors according to the approved product guidelines SmPC. Treatment and visit schedules are determined by the treating physician and are not fixed by the study protocol. Patients will also be informed about using a digital healthcare application DiGA during the study. The study includes two cohorts based on HER2 status, both receiving T-DXd in routine care. During the study, participants will be followed to measure the time until their next treatment or death, assessed for up to 60 months from the first T-DXd dose. Quality of life will be evaluated using questionnaires at six months after baseline. Patient safety and treatment effects will be monitored through data collected in routine clinical visits. The total participation period may extend up to eight years, allowing for long-term observation of treatment outcomes in real-world settings.