Gutersloh

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are collecting data in a registry study focused on adults with newly diagnosed or relapsed acute myeloid leukemia (AML). The study aims to gather detailed epidemiological information such as age, prognostic factors, and subgroup distributions. It also compares AML incidence and age distribution with population-based tumor registry data. Important clinical outcomes like relapse-free survival, time to relapse, cumulative incidence of relapse, and overall survival are being evaluated over a 10-year period. This study does not involve experimental treatments but instead documents current treatment strategies used in AML patients. Data collection occurs at 60 investigator sites across Germany, providing a broad overview of patient characteristics and management. There is no upper age limit, and all adult patients diagnosed according to WHO criteria, including acute promyelocytic leukemia, are eligible. Participants will be followed for up to 10 years, during which epidemiological parameters and survival outcomes will be monitored. Researchers will record relapse events, time until relapse, and survival status to understand long-term outcomes. This extensive follow-up intends to support improved knowledge about AML patient prognoses and treatment impacts over time.

Researchers are evaluating the effects of stopping CDK4/6 inhibitors in women with metastatic hormone receptor-positive, HER2-negative breast cancer who have had long-lasting disease control. This phase II, low-intervention trial aims to assess whether patients can maintain stable disease after discontinuing CDK4/6 inhibitors following at least 12 months of combined treatment with endocrine therapy. The study focuses on long-term disease stabilization and progression-free survival 12 months after randomization. Participants are assigned to either continue or discontinue CDK4/6 inhibitors such as Palbociclib or Abemaciclib while maintaining endocrine therapy. The study is open-label and multicenter, allowing close observation of treatment effects. During the trial, patients will be monitored to see if disease control persists after stopping the CDK4/6 inhibitor treatment. Throughout the study, participants undergo regular assessments including evaluations of disease status and safety monitoring. Researchers will track progression-free survival at 12 months after randomization as the primary outcome. The trial includes detailed monitoring of participants' health and treatment responses to understand the impact of discontinuing CDK4/6 inhibitors in this patient population.

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.

Researchers are evaluating the effectiveness and safety of combining carboplatin, paclitaxel, bevacizumab, and niraparib compared to carboplatin and paclitaxel followed by niraparib alone in women newly diagnosed with advanced ovarian, peritoneal, or fallopian tube cancer. This Phase III international, multicenter, randomized open trial focuses on patients with specific advanced stages of these cancers who have undergone or plan to undergo surgery and chemotherapy. The study aims to see if adding bevacizumab to the treatment improves progression free survival. All participants first receive one cycle of chemotherapy with carboplatin and paclitaxel. Based on tumor BRCA testing, patients are then randomly assigned to one of two groups: one group receives five more cycles of carboplatin and paclitaxel followed by daily niraparib for up to three years; the other group receives the same chemotherapy combined with bevacizumab, continuing bevacizumab for up to one year and niraparib daily for up to three years. Treatment schedules follow a three-week cycle. Participants will be closely monitored throughout the trial with frequent assessments to track progression free survival until either 586 events occur or three years after the last patient joins, whichever happens first. The study includes detailed safety evaluations, laboratory tests, and patient questionnaires. To participate, women must meet specific health criteria, including performance status and organ function, and agree to follow study procedures for up to three years of treatment and observation.

Researchers are evaluating real-world clinical data in women with primary advanced (FIGO stage III or IV) or recurrent endometrial cancer who are receiving first-line treatment with Carboplatin, Paclitaxel, and Durvalumab (CPD). The study focuses on patients treated with CPD followed by maintenance therapy using either durvalumab alone or durvalumab combined with olaparib. This multi-center, prospective, non-interventional study aims to understand the effectiveness, safety, and patient-reported outcomes of these treatments in routine clinical practice in Germany. Participants receive first-line CPD chemotherapy after surgery and/or radiation if applicable. Following this, maintenance therapy is given with durvalumab for patients with DNA mismatch repair deficient tumors (dMMR cohort) or with durvalumab plus olaparib for those with DNA mismatch repair proficient tumors (pMMR cohort). Treatment decisions are made jointly by patients and their physicians as part of standard care, independent of the study itself. During the study, data on treatment effectiveness and safety will be collected along with patient-reported outcomes after the chemotherapy phase. Researchers will monitor real-world time to the next treatment over 12 months. Patients will complete questionnaires and their tumor mismatch repair status must be known. The study includes women aged 18 years or older and involves regular follow-ups to gather comprehensive information about the treatment effects and patient experience.

Out-of-hospital cardiac arrest (OHCA) is a leading cause of death with low chances of survival until hospital discharge. Researchers are evaluating how different ventilation strategies during resuscitation may affect oxygen delivery and patient outcomes. This trial focuses on comparing positive-end-expiratory-pressure (PEEP) set at 5 mbar versus zero-end-expiratory-pressure (ZEEP) in adult patients who experience OHCA. This prospective, multicenter, cluster-randomized controlled trial enrolls adults aged 18 years and older with non-traumatic OHCA who require mechanical ventilation via an airway device. Participants are grouped by regional districts and randomized to receive either ventilation with PEEP at 5 mbar (intervention group) or ventilation with ZEEP at 0 mbar (control group). The primary goal is to observe the rate of return of spontaneous circulation (ROSC) during or after resuscitation. Participants will be treated and monitored by emergency medical services across several regions. Researchers will track outcomes such as the rate of re-arrest, death during pre-hospital care, hospital admission status during ongoing resuscitation, and hospital admission with spontaneous circulation. Additional measures include peripheral oxygen saturation and end tidal CO2 at hospital admission, helping assess the effectiveness and safety of the ventilation strategies used.

Researchers are evaluating the effectiveness and safety of Datopotamab Deruxtecan (Dato-DXd) combined with Rilvegostomig or Rilvegostomig alone compared to Pembrolizumab alone as first-line treatments for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Participants must have high PD-L1 expression (tumor cells 50% or greater) and no actionable genetic changes. This Phase III, randomized, open-label global study focuses on this specific group of lung cancer patients without known targetable mutations. The trial includes three treatment groups: one receiving Dato-DXd plus Rilvegostomig intravenously, one receiving Rilvegostomig alone intravenously, and one receiving Pembrolizumab alone intravenously. Treatments are given as first-line therapy, meaning participants have not received prior systemic treatment for advanced disease. The study compares these treatments to assess their effect on cancer progression and survival. Participants will be closely monitored throughout the study, which includes assessments of progression-free survival over about four years and overall survival over about six years. Researchers will collect tumor samples to confirm PD-L1 and TROP2 status, perform scans to measure tumor response, and evaluate organ function and performance status. Safety and side effects will be tracked to understand treatment tolerability. The entire participation duration may extend up to several years to capture long-term outcomes.

Researchers are studying patients who have survived a heart attack (myocardial infarction) and are at higher risk for sudden cardiac death caused by dangerous heart rhythms. This study focuses on patients with a severely reduced heart function measured by left ventricular ejection fraction (LVEF) of 35% or less. Previous landmark trials showed that implantable cardioverter-defibrillators (ICDs) improved survival compared to medical therapy alone, but since then, new medications have decreased sudden death rates and the need for ICD therapy. Because ICDs carry risks and costs, this study aims to compare modern optimal medical therapy (OMT) alone versus OMT with ICD implantation to see if medical therapy without ICD is not worse for patient survival. Participants will be divided into two groups: one receiving OMT only and the other receiving OMT plus an ICD device. The ICD options include transvenous ICDs, subcutaneous defibrillators, or a newer extravascular ICD with substernal lead placement. OMT will follow current European guidelines for managing coronary syndromes and heart failure. The study is designed to assess outcomes over time from the point of randomization. During the study, researchers will track survival by measuring the time until death from any cause, expecting about 15 months of follow-up after the last participant joins. Patients must have a history of heart attack at least three months prior, symptomatic heart failure, and have been on OMT for at least three months before enrollment. Safety and effectiveness of treatments will be monitored closely throughout the study period.