Leer Ostfriesland

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 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 investigating ribociclib combined with standard endocrine therapy for women with advanced hormone receptor-positive HR and HER2-negative breast cancer receiving first-line treatment. This phase IV, open-label study aims to understand how ribociclib works over time and identify patterns of resistance. The study also focuses on survival rates at 12 months and includes a comprehensive program to discover and validate biomarkers related to treatment outcomes. Participants will receive ribociclib once daily for 21 days followed by 7 days off, in 28-day cycles, alongside standard endocrine therapy prescribed by their doctors. The treatment follows the approved guidelines Summary of Product Characteristics for ribociclib. This trial plans to enroll 1000 female patients across 75 sites in Germany and involves extensive biomarker sampling from blood, tissue, and immune cells before, during, and after treatment or disease progression. During the study, participants will have regular assessments including survival monitoring at various time points up to 36 months, quality of life evaluations, and safety checks for treatment-related side effects. Samples for biomarker research will be collected to help understand treatment response. Follow-up includes collecting data on progression-free and overall survival, quality of life, and adverse events, with total study involvement lasting up to 36 months.

Researchers are studying patients with ER-positive, HER2-negative breast cancer who have experienced a relapse detected through circulating tumor DNA ctDNA testing. This phase III international trial compares a new drug, elacestrant, with standard endocrine therapies to determine which is better at preventing distant metastasis in these patients. The study includes a ctDNA screening phase to identify eligible patients who have no evidence of distant metastases. During the ctDNA screening phase, patients will undergo blood tests every six months to detect ctDNA while continuing standard endocrine therapy, such as tamoxifen or an aromatase inhibitor. If ctDNA is detected without distant metastases, patients are randomized to receive either elacestrant 400 mg daily or continue their current endocrine treatment. Treatment duration varies from 2 to 6 years depending on prior endocrine therapy exposure, followed by physician-directed care after protocol completion. Participants will have regular follow-up visits with ctDNA tests at weeks 4, 16, and every 16 weeks thereafter for up to three years to monitor disease markers. Imaging studies including mammograms, bone scans, and CT scans will be performed regularly to check for cancer recurrence. Researchers will measure outcomes such as distant metastasis-free survival and quality of life over a long-term period, with safety and survival assessments continuing up to nearly 12 years after study entry.

This research aims to gather a large group of patients diagnosed with BCR-ABL 1-negative myeloid neoplasms, classified according to WHO 20082016 standards. The study focuses on collecting detailed clinical, biological, and quality-of-life data to better understand disease characteristics, outcomes, and potential prognostic markers. It is an observational registry conducted by the University of Ulm to improve knowledge about this condition over time. Participants in this registry will provide various biological samples, such as bone marrow aspirate, peripheral blood, plasma, buccal swabs, and occasionally skin biopsies. These samples will be used for morphological and genetic analysis. The study does not involve any experimental treatments but collects comprehensive data and samples to assess disease features and clinical outcomes. Throughout the study, researchers will collect clinical information using a defined catalog of relevant variables and assess quality of life with specific symptom assessment forms. They will track outcomes including treatment decisions, responses, overall survival, progression-free survival, and duration of response for up to 25 years. This long-term follow-up allows detailed monitoring of patient health and disease progression.

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 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 studying patients with breast cancer, focusing on those with metastatic disease who typically have the poorest outlook. The trial aims to improve treatment decisions and quality of care by analyzing tumor characteristics. Although national guidelines recommend molecular reassessment of metastatic tumors, biopsies are rare due to invasiveness, so the study explores blood-based methods to assess tumor features and their relation to treatment outcomes and health economics. The study involves two groups about 3,500 patients with locally advanced or metastatic breast cancer receiving any line of treatment, and approximately 10,000 patients with early breast cancer undergoing neoadjuvant or adjuvant therapy regardless of regimen. Blood samples will be collected during routine blood draws to analyze tumor molecular characteristics and biomarkers for progression and survival. Participants will be followed with assessments including quality of life, therapy adherence, depression factors, and adverse events at study entry and regularly up to 60 months. The study will measure progression-free survival in metastatic breast cancer and disease-free survival in early breast cancer, along with overall survival and health economic outcomes. Results of molecular testing will be shared with patients at study end, providing comprehensive data to support improved breast cancer care.

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.