Passau

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 observing the safety and performance of Abbott annuloplasty devices used in surgeries to repair mitral and tricuspid valve regurgitation. This study includes devices such as the SJM Rigid Saddle Ring, SJM Sguin Annuloplasty Ring, SJM Tailor Annuloplasty Ring, and SJM Tailor Annuloplasty Band. The trial aims to meet post-market clinical follow-up requirements and follows up with participants for five years after their valve repair surgery. Participants will be grouped based on their specific valve condition and the device implanted during surgery. The five groups include primary and secondary mitral disease repairs using different annuloplasty rings, as well as primary and secondary tricuspid disease repairs using the Tailor Ring or Tailor Band. Enrollment occurs before surgery, and subjects will be implanted with one of these Abbott devices as part of their standard surgical care. After implantation, participants will complete yearly follow-up visits either in clinic or by phone for up to five years. Data collected will include any adverse events, use of cardiac medications, heart failure symptom severity measured by the New York Heart Association functional classification, and echocardiographic assessments of valve regurgitation. The study will measure outcomes such as survival rates, need for reoperation or reintervention, and improvement in heart function over time.

Researchers are evaluating the addition of bleximenib to standard chemotherapy for adults with newly diagnosed acute myeloid leukemia AML who have specific genetic mutations in the NPM1 or KMT2A genes. This phase 3, randomized, double-blind, placebo-controlled trial aims to see if bleximenib can improve treatment outcomes compared to chemotherapy alone. The study includes patients eligible for intensive chemotherapy and focuses on those with DNA changes in their leukemia cells. Participants will receive standard chemotherapy combined with either bleximenib or a placebo. Treatment includes remission induction and consolidation therapy, followed by maintenance therapy with either bleximenib or placebo depending on the group. Treatment will continue until disease progression, unacceptable side effects, or other criteria require stopping. The study involves three groups one receiving bleximenib throughout, one receiving bleximenib during initial therapy and placebo for maintenance, and one receiving placebo throughout. Participants will be monitored for up to 4 years and 5 months to assess event-free survival, with additional follow-up up to nearly 8 years to evaluate overall survival and remission rates. Researchers will collect data on treatment response, remission duration, and the number of participants undergoing stem cell transplants. Safety and long-term outcomes will be observed to understand the effects of adding bleximenib to standard therapy.

Researchers are evaluating whether systematic pelvic and para-aortic lymphadenectomy LNE improves overall survival in patients with stage I or II endometrial cancer who have a high risk of recurrence. The trial also looks at how LNE affects disease-free survival, quality of life, complications, side effects, and the number of lymph nodes removed. A total of 640 patients with specific histological types and stages of endometrial cancer will take part in this study. Participants will be randomly assigned to one of two groups. In Arm A, patients will undergo the standard surgical procedure including total hysterectomy and bilateral salpingo-oophorectomy, with an omentectomy added for certain cancer types. In Arm B, patients will receive the same standard surgery plus systematic pelvic and para-aortic lymphadenectomy reaching up to the left renal vein. The study compares these two surgical approaches. Throughout the study, participants will be monitored for overall survival over 60 months. Researchers will also assess disease-free and disease-specific survival at multiple time points up to five years. Serious complications will be recorded during surgery and follow-up visits. Quality of life will be evaluated regularly using standardized questionnaires. The number of lymph nodes removed will be documented during surgery to support the evaluation of treatment impact and safety.

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.

Cholangiocarcinoma is a rare and aggressive bile duct tumor with poor outcomes and limited treatment options. Researchers are collecting real-world data on ivosidenib, an IDH1 inhibitor recently approved in Europe for adults with locally advanced or metastatic cholangiocarcinoma carrying an IDH1 R132 mutation who have undergone at least one prior systemic treatment. This observational study aims to evaluate ivosidenibs effectiveness, safety, and impact on quality of life in a broad patient population in Germany. Ivosidenib is given as monotherapy according to the current summary of product characteristics SmPC. The study follows patients receiving ivosidenib under routine clinical care without altering treatment decisions. It will gather data on treatment dosing, modifications, duration, and reasons for stopping treatment. Optional patient-reported outcomes PRO assessments are available for those who can participate in German. Participants are monitored during treatment and follow-up for up to 38 months from first patient in to last patient last visit. The study collects information on progression-free survival, overall survival, adverse events, quality of life related to cholangiocarcinoma, and physician treatment decisions. Data on prior therapies, concomitant medications, and subsequent cancer treatments are also recorded to assess real-world use and safety of ivosidenib.

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 treatments for adults aged 18 to 65 with newly diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia Ph ALL. This phase 2 multicenter trial, sponsored by Goethe University, aims to compare the current standard treatment of Imatinib plus low-dose chemotherapy with Ponatinib plus chemotherapy. It also seeks to explore different treatment strategies based on patients molecular response to therapy, including the use of Blinatumomab and the role of stem cell transplantation. Participants receive either Imatinib 600 mg once daily or Ponatinib 45 mg once daily reduced to 30 mg after induction, both combined with low-dose chemotherapy during induction and consolidation phases. Patients with a good molecular response are randomized to either end therapy with indication for stem cell transplantation or continue treatment with TKI, chemotherapy, and Blinatumomab. Those with poor molecular response receive Blinatumomab followed by end of therapy and transplantation indication. Stem cell transplantation itself is not part of the trial. During the study, participants undergo molecular evaluations for BCR-ABL1, regular monitoring of blood counts, and assessments of treatment response. Researchers measure overall survival in molecular complete remission patients receiving TKI-chemotherapy-Blinatumomab versus standard end of therapy with transplantation indication. Safety and remission rates are also tracked. The study involves follow-up for up to four years from randomization to assess long-term outcomes and treatment effects.

This observational registry study collects real-world data on the Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A, in patients who need replacement of their native or prosthetic aortic valve as the only heart valve procedure. The study aims to monitor hemodynamic and clinical outcomes to better understand the valves performance in routine medical practice. Up to 500 subjects will be enrolled at up to 20 sites in Germany. Participants will receive the INSPIRIS RESILIA Aortic Valve through surgical replacement during their index procedure. The study records data from standard-of-care imaging evaluations such as echocardiography and CT scans before the valve replacement. There is no randomization or comparator group as this is an observational study focusing on patients treated with this specific valve. Participants heart function and valve performance will be assessed primarily by measuring average mean and peak gradients, and the amount of aortic transvalvular and paravalvular regurgitation. These measurements will be taken prior to discharge typically 7 to 10 days after surgery and at 3 months post-surgery. Additionally, patients New York Heart Association functional classification will be evaluated at baseline and after 3 months. The study involves standard clinical visits and imaging as part of routine care, with data collected for up to 3 months after valve implantation.

Researchers are conducting a registry study involving adult patients diagnosed with acute myeloid leukemia AML and related myeloid neoplasms, including newly diagnosed or relapsedrefractory cases. The study aims to collect comprehensive data on patient characteristics, family history, biological disease profiles, and clinical outcomes. It also focuses on analyzing disease-related genetic markers and the impact of measurable residual disease MRD using various methods. The study does not involve specific treatments but collects data and biological samples such as bone marrow, blood, plasma, and normal tissue including skin biopsies and other specimens. This observational study enrolls patients from around 80 to 90 sites in Germany and Austria. Patients treatment responses, decisions, and outcomes are tracked over time. Participants are observed for up to 10 years, during which researchers gather information on treatment response, survival, relapse rates, quality of life, and genetic markers. The study includes assessments of event-free survival, relapse-free survival, cumulative incidence of relapse and death, and overall survival. Patient consent is required for registration, data storage, and biobanking of specimens for analysis throughout the observation period.