Passau

Researchers are evaluating the real-world effectiveness, safety, and tolerability of ribociclib combined with an aromatase inhibitor, with or without luteinizing hormone-releasing hormone (LHRH) therapy, for adjuvant treatment in patients with hormone receptor-positive, HER2-negative early breast cancer at high risk of recurrence. The study also compares data from patients treated with abemaciclib plus endocrine therapy with or without LHRH, and those receiving endocrine monotherapy with or without LHRH. This observational study aims to understand treatment decisions and clinical use of ribociclib after its approval, collecting socio-economic data, quality of life, and patient compliance information. Participants receive treatment based on their physician's clinical judgment without study-assigned interventions. The treatments observed include ribociclib with an aromatase inhibitor LHRH, abemaciclib with endocrine therapy LHRH, or endocrine monotherapy LHRH. The study is conducted in various breast cancer centers and gynecological practices in Germany and Austria to represent local healthcare settings. Participants undergo assessments to monitor treatment effectiveness, safety, quality of life, and adherence to therapy over time. Data collected include clinical outcomes, adverse events, socio-economic status, and patient-reported compliance. The primary outcome measured is invasive disease-free survival over 36 months. This information will help inform clinical decision-making and improve outcomes for patients with early breast cancer in routine practice.

Researchers are evaluating the safety and performance of Abbott annuloplasty devices used in surgical repair for mitral and tricuspid valve regurgitation. This multicenter observational study aims to meet post-market clinical follow-up requirements and includes adults undergoing valve repair surgery involving Abbott annuloplasty implants. The study includes several treatment groups based on the type of valve disease and implant used, with up to 550 participants followed for five years after implant. The study involves five groups: primary mitral disease repair with the Rigid Saddle Ring, Se9guin Ring, or full Tailor Ring; secondary mitral disease repair with those same devices; primary tricuspid disease repair with the full Tailor Ring; secondary tricuspid repair with the full Tailor Ring; and primary tricuspid repair with the Tailor Band or partial Tailor Ring with cut zone removed. Participants receive one of these Abbott annuloplasty devices during surgery. The devices vary in rigidity and flexibility, designed to repair the valves effectively. Participants will be followed annually for five years through in-clinic or telephone visits to collect data on adverse events, medication use, heart failure symptom severity using the New York Heart Association classification, and echocardiographic assessments of valve regurgitation. The primary outcomes include rates of survival, freedom from reoperation or reintervention for mitral regurgitation at five years, and improvement in heart failure symptoms at one year. This long-term monitoring helps understand device performance and patient health over time.

Researchers are evaluating whether systematic pelvic and para-aortic lymphadenectomy (LNE) improves overall survival in women with stage I or II endometrial cancer who have a high risk of recurrence. The study also aims to assess the impact of LNE on disease-free survival, quality of life, complications, side effects, and the number of lymph nodes removed. A total of 640 patients with confirmed high-risk endometrial cancer will be included in the trial. Participants will be randomly assigned to one of two groups. In the first group, patients will undergo a total hysterectomy and bilateral salpingo-oophorectomy, with an additional omentectomy if they have serous or clear cell cancer types. The second group will receive the same procedures plus systematic pelvic and para-aortic lymphadenectomy up to the level of the left renal vein. This approach allows comparison between standard surgery and surgery with lymphadenectomy. During the study, patients will be monitored for overall survival over 60 months. Researchers will also evaluate disease-free survival and quality of life, while tracking complications and side effects of the treatments. Informed consent will be obtained, and patients’ compliance and health status will be regularly assessed. The trial includes close follow-up to observe long-term effects and outcomes of the surgical procedures.

Researchers are collecting detailed information on adults diagnosed with Acute Lymphoblastic Leukemia (ALL) and related blood cancers such as other leukemias and certain types of Non-Hodgkin's Lymphoma. The purpose is to gather real-world data on diagnosis, treatments, and outcomes to support ALL research and improve quality of care. This registry includes patients whether or not they are part of other clinical trials. Participants included in this registry are adults aged 18 and older diagnosed with ALL or similar leukemias who are treated according to established ALL treatment protocols. It also includes patients with specific subtypes of Non-Hodgkin's Lymphoma treated according to B-ALL protocols. The study involves collecting clinical data and biological samples over time to understand treatment responses and disease progression. Throughout the study, researchers will monitor participants' health outcomes, including overall survival for up to 10 years. Data collected will cover diagnostics, treatments received, and patient outcomes in routine clinical care. This long-term follow-up aims to provide valuable insights into the effectiveness of current therapies and patient experiences with these blood cancers.

The trial investigates the effectiveness, safety, and patients' quality of life when using additive chemotherapy after surgery or ablation in patients with metastatic colorectal cancer. This phase III, open-label, randomized, controlled, multicenter study compares two groups: one receiving chemotherapy and the other undergoing active follow-up without additional treatment. All patients have had their metastatic lesions definitively treated before joining the trial. Participants in the chemotherapy group receive up to six months of treatment with either mFOLFOXIRI or mFOLFOX-6, with up to 12 cycles administered every two weeks. The other group undergoes active surveillance without further chemotherapy. The study includes regular tumor biopsies at screening and upon relapse if possible, aiming to study tumor and blood markers. Imaging scans such as CT or MRI of the chest and abdomen are performed every three months during the first two years, then every six months thereafter, with follow-up continuing for up to five years. Throughout the study, patients are monitored every three months with radiologic assessments, blood tests, and quality of life questionnaires. Researchers aim to detect any cancer relapse through imaging and blood markers and evaluate progression-free survival over 24 months. Safety and clinical status are regularly assessed, and structured follow-up is maintained for both groups up to 60 months after randomization.

Researchers are studying adult patients with newly diagnosed Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL) to evaluate different treatment approaches involving tyrosine kinase inhibitors (TKIs) combined with low-dose chemotherapy. The trial aims to compare Ponatinib versus Imatinib, both combined with chemotherapy, and to assess different strategies based on patients' molecular response to therapy. The study challenges the current standard of care by examining alternative treatments for patients who respond well or poorly to initial therapy. Participants receive either Imatinib at 600 mg once daily with chemotherapy or Ponatinib at 45 mg once daily with chemotherapy. Patients with molecular failure or intermediate response receive one cycle of Blinatumomab before stem cell transplantation (SCT). Those who achieve molecular complete remission (CR) and are randomized to the experimental arm receive three cycles of Blinatumomab plus chemotherapy, while patients in the standard arm or with molecular failure or intermediate response have an indication for SCT. The trial includes randomization to different treatments and a non-randomized Blinatumomab treatment for suboptimal responders. During the study, participants will be monitored for overall survival up to four years from randomization. Molecular evaluations for BCR-ABL1 are performed to guide treatment decisions, and safety is closely observed. Patients must consent to participate in a registry and agree to contraception requirements if applicable. Clinical assessments include performance status, blood tests, and cardiac monitoring. The study involves multiple centers and aims to gather long-term data on survival outcomes and treatment effectiveness.

Researchers are collecting real-world data on the hemodynamic and clinical outcomes of the INSPIRIS RESILIA Aortic Valve, Model 11500A. This study focuses on patients who need replacement of their native or prosthetic aortic valve as the only heart valve procedure during their surgery. The aim is to understand the performance and effects of this valve in routine clinical practice. The study involves surgical replacement of the aortic valve with the Edwards INSPIRIS RESILIA Aortic Valve. Up to 500 patients will be enrolled across up to 20 sites in Germany. The valve implantation is the main intervention, and patients may have other non-heart valve procedures alongside the surgery if applicable. The registry is observational, tracking outcomes following this surgical valve replacement. Participants will be followed with assessments including echocardiography and CT imaging before the procedure. Outcomes measured include the subject's average mean and peak pressure gradients across the valve, as well as the amount of aortic transvalvular and paravalvular regurgitation. These measures will be evaluated before discharge, about 7 to 10 days after surgery, and again at 3 months. Written informed consent and standard pre-procedure imaging data are required for enrollment.

This research focuses on adult patients with newly diagnosed or relapsed/refractory acute myeloid leukemia (AML) and related myeloid neoplasms. It aims to register all patients treated at approximately 80-90 sites in Germany and Austria, capturing comprehensive data on patient characteristics, family history, biological disease features, and clinical outcomes. The study also seeks to analyze genetic markers related to the disease and evaluate treatment responses and survival outcomes over an extended period. Patients enrolled in the study will have their disease-related genetic markers analyzed rapidly to inform treatment recommendations. Biosamples such as bone marrow, blood, plasma, skin biopsy, fingernails, hair, sputum, or urine will be collected and stored for further analysis. The study intends to assess measurable residual disease using various methods and correlate biological markers with clinical outcomes. Participants will be observed for up to 10 years, during which researchers will monitor event-free survival, relapse-free survival, cumulative incidence of relapse and death, overall survival, and quality of life. Treatment decisions, response to therapy, and geographical representation will also be recorded. Data collection includes clinical assessments and storage of biosamples, with ongoing evaluation of disease progression and patient outcomes throughout the study period.