Vogtei

Researchers are studying children and young adults aged 1 to 18 years with chronic kidney disease CKD and proteinuria, a condition where the kidneys leak protein into the urine. This study aims to evaluate the long-term safety of finerenone when added to standard treatments called ACE inhibitors or angiotensin receptor blockers ARBs, which are commonly used to control blood pressure and protect kidney function. The research also seeks to understand how well finerenone can reduce protein levels in urine and support kidney health over time. Participants will receive finerenone in doses adjusted by age and body weight, taken orally for up to 18 months alongside their usual ACEI or ARB treatment. The study includes patients who previously took part in a related trial and will follow them for about 19 months, including a one-month follow-up after treatment ends. The research involves one group receiving finerenone openly without placebo or comparison groups. During the study, participants will attend at least 8 to 12 visits depending on their treatment start status. At these visits, doctors will measure vital signs like blood pressure, heart rate, weight, and height perform physical exams collect blood and urine samples to monitor kidney function and protein levels and conduct heart tests using electrocardiograms and echocardiography. Participants and their caregivers will also answer questions about medication use, side effects, and overall well-being. Safety will be closely monitored by tracking any medical problems that arise during the trial.

Researchers are conducting a national, prospective, longitudinal, multicenter observational study to document detailed information on the treatment and progression of breast cancer in Germany. This study aims to collect uniform data on patient characteristics, molecular diagnostics, treatments, disease course, and patient-reported health-related quality of life over time. The study includes both early and advanced breast cancer patients and seeks to understand common treatment sequences and changes in therapies. Participants are divided into groups based on breast cancer subtype and stage, including HER2-positive, triple negative, and hormone receptor positive HER2-negative types, for both early and advanced breast cancer. Data collection involves recording all systemic treatments, radiotherapies, surgeries, and outcomes during up to five years of follow-up. The study also includes a decentralized biobank and patient-reported outcomes collected through questionnaires. During the study, researchers gather data at the start of treatment and throughout the observation period, including tumor characteristics, previous treatments, comorbidities, and ongoing therapy details. Key outcome measures include treatment reality, best response, progression-free survival, overall survival, disease-free survival, and patient-reported quality of life. Participation involves regular documentation and questionnaires, enabling comprehensive tracking of breast cancer treatment and outcomes over five years.

Researchers are investigating whether early atrial fibrillation ablation reduces cardiovascular events in patients with atrial fibrillation who have a high burden of other health problems, measured by a CHA2DS2-VASc score of 4 or more. This is an international, randomized, open trial designed to compare early ablation with usual care to see if it lowers risks of stroke, cardiovascular death, or heart failure events. The study also looks at safety, patient-reported outcomes, and cognitive function in this population. Participants are randomly assigned to one of two groups one group undergoes early atrial fibrillation ablation, specifically pulmonary vein isolation within two months of randomization, while the other group receives usual care following guideline-based treatments tailored to their individual medical needs. All treatments involved are approved therapies. The trial aims to enroll 2312 patients and will continue until a set number of cardiovascular events have occurred, with an estimated average follow-up of about four years. During the study, researchers will monitor cardiovascular complications including death, stroke, and hospitalizations related to heart failure. They will also track serious complications from atrial fibrillation therapy and assess quality of life, heart function, rhythm status, cognitive function, and hospital stays over the follow-up period. Patients will be regularly evaluated for both safety and effectiveness outcomes throughout the study duration.

Researchers are conducting a national, prospective, longitudinal study in Germany to collect detailed information on patients with Hepatocellular Carcinoma HCC or Cholangiocarcinoma CCC. The study aims to document patient characteristics, molecular diagnostics, treatments, and disease progression, as well as gather patient-reported outcomes and establish a decentralized biobank. This observational registry will help understand common treatment patterns and changes over time for these liver cancers. Patients diagnosed with HCC or CCC will be followed for up to three years. The study records data on systemic treatments, radiotherapies, surgeries, and outcomes as part of routine care determined by the treating physicians. Data collection includes patient characteristics, comorbidities, tumor details, and previous treatments at the time of inclusion. Patients are grouped based on their specific cancer type, either HCC or CCC. Participants will undergo regular evaluations throughout the three-year follow-up period. Researchers will monitor the course of treatment, treatment responses, progression-free survival, overall survival, and health-related quality of life through patient-reported outcomes. The study collects comprehensive data to better understand treatment realities and patient experiences, supporting improved care for liver cancer patients.

This research aims to establish a national, prospective, longitudinal, multicenter cohort study in Germany to collect standardized data on patients with Multiple Myeloma. The study focuses on documenting patient characteristics, molecular diagnostics, treatments, and disease progression over time. The goal is to better understand treatment patterns and outcomes across different therapies for Multiple Myeloma, while also collecting patient-reported quality of life measures. Participants receive routine care as determined by their physicians based on individual needs without experimental interventions. The study tracks all systemic treatments, radiotherapies, surgeries, and disease outcomes for up to five years. A decentralized biobank is also established to support molecular testing and research alongside the registry. The study includes a satellite project evaluating health-related quality of life through patient questionnaires. During participation, data on patient conditions, prior treatments, and comorbidities are collected at enrollment. Follow-up data include treatment details, response to therapy, survival outcomes, and quality of life assessments over five years. Researchers use these data to analyze treatment sequences, disease course, and patient well-being. Participation involves routine monitoring without additional treatment procedures, and the total follow-up can last up to five years.

This study is a national, observational research project focusing on patients with metastatic esophageal, gastric, or gastroesophageal junction cancer in Germany. It aims to collect detailed information on antineoplastic treatments given with palliative intent in routine clinical practice. The goal is to understand the common treatment sequences, changes over time, and their outcomes, especially quality of life, in patients receiving systemic therapy for these cancers. Participants receive routine care based on their physicians choice and clinical needs, reflecting standard treatments used in daily practice. The study follows patients for up to two years, documenting all systemic treatments, radiotherapy, surgeries, and related outcomes longitudinally. No experimental treatments are assigned, as this is an observational study capturing real-world clinical data. Throughout the study, data on patient characteristics, tumor details, comorbidities, and prior treatments are collected at the start. During follow-up, researchers monitor treatments and outcomes, including health-related quality of life, via questionnaires and medical records. The primary outcome is the course of treatment over two years. Participants usual care continues uninterrupted, and data collection helps provide a comprehensive picture of treatment patterns and patient experiences.

Researchers are conducting a national, prospective, longitudinal, multicenter cohort study in Germany to collect detailed data on patients with advanced or metastatic ovarian cancer OC or endometrial cancer EC. This study aims to document tumor characteristics, molecular diagnostics, treatments, and disease progression, while also gathering patient-reported outcomes and establishing a decentralized biobank. The study focuses on high-grade ovarian, fallopian tube, primary peritoneal cancers, and advanced endometrial cancer in routine clinical practice. Participants include female patients with high-grade advanced or metastatic OC who are either newly diagnosed at FIGO stage IIb-IV and starting systemic treatment or have recurrent disease starting treatment for relapse. Also included are female patients with locally advanced or metastatic endometrial cancer FIGO stage III-IV beginning systemic first-line therapy. Treatment follows physicians choice based on patient needs and routine care standards without any experimental interventions. Participants will be followed for up to three years, with data collected at inclusion on patient characteristics, comorbidities, tumor features, and previous treatments. During observation, all systemic treatments, surgeries, radiotherapies, and outcomes will be documented. Health-related quality of life will be evaluated through patient-reported outcomes. The study will monitor the course of treatment, best response, progression-free survival, overall survival, and quality of life over the three-year period.

Researchers are conducting a national, prospective, longitudinal, multicenter observational study called CARAT to collect detailed information on patients with advanced renal cell carcinoma and urothelial cancer in Germany. This study aims to gather uniform data on patient characteristics, molecular diagnostics, treatments, and disease progression. It includes patients with advanced renal carcinoma, advanced urothelial cancer, and muscle-invasive bladder cancer, tracking their treatment courses and outcomes over several years. Participants receive routine care as per their treating physicians choice, reflecting standard clinical practice. The study follows patients with advanced renal carcinoma for up to three years, those with advanced urothelial cancer for up to two years, and patients with muscle-invasive bladder cancer for up to five years. Data collection includes systemic treatments, surgeries, radiotherapies, perioperative therapies, and neoadjuvant therapies, depending on the cancer type and patient cohort. During the study, researchers collect data on patient characteristics, tumor features, previous and ongoing treatments, and outcomes, including patient-reported health-related quality of life for up to two years. They monitor treatment responses, progression-free survival, overall survival, and symptom-related quality of life. This comprehensive data helps identify common treatment sequences and changes over time, providing valuable insights into the real-world management of these cancers.

Researchers are conducting a national, prospective, longitudinal, multicenter cohort study called RHODOLITE to gather consistent data on characteristics, molecular diagnostics, treatment, disease progression, and patient-reported outcomes for individuals with primary and secondary myelofibrosis and anemia in Germany. The study aims to understand treatment patterns and changes over time among patients starting or continuing systemic therapy for myelofibrosis. RHODOLITE is an open-label, non-interventional observational study without assigned treatments. Patients will be followed for up to three years to document all systemic treatments and therapy sequences received in routine clinical care. The study also involves collaboration with the German Study Group for Myeloproliferative Neoplasms GSG-MPN Bioregistry, which will provide additional long-term follow-up for at least five years. Participants will provide data on their health, treatments, and quality of life during the study. Health-related quality of life and myelofibrosis-related symptoms will be assessed through patient-reported outcomes for up to three years. Researchers will monitor hematologic and splenic responses, overall response rates, progression-free and overall survival, and document systemic treatment courses. Participation involves providing informed consent and completing quality of life assessments alongside routine clinical data collection.

Researchers are investigating how well the drug VITRAKVI generic name larotrectinib works and how well patients tolerate it in real-world use for those with TRK fusion cancer. This cancer type involves a genetic change called an NTRK gene fusion that can cause tumors to grow. The study includes adults and children with locally advanced or metastatic solid tumors that have this specific gene fusion, reflecting a variety of common and rare cancers. Patients enrolled in this observational study are those for whom their doctors have decided to treat with larotrectinib. Treatments and medical care follow local standard practices without interference from the study. Participants are grouped based on cancer types like gastrointestinal, head and neck, soft tissue sarcoma, CNS, lung, melanoma, pediatric tumors, and others. Data on treatments, other medications, disease changes, and health symptoms will be collected during routine care. Participants will be observed for 24 to 60 months. Researchers will collect information on treatment side effects up to 30 days after treatment ends and monitor responses, disease control, survival, doses, and developmental milestones for up to 8 years. Medical records, including height, weight, neurological assessments, and Tanner stage will be reviewed as part of this long-term observation.