Recklinghausen

Researchers are studying the clinical and health-related outcomes of treatments containing amivantamab for people with common EGFR-mutated advanced non-small cell lung cancer (NSCLC), which is the most common type of lung cancer. This type of cancer can spread to other parts of the body and occurs due to changes in genes such as the epidermal growth factor receptor (EGFR). The study focuses on real-world use of these treatments outside of controlled clinical trials. Participants will receive amivantamab-containing regimens as part of their standard care, decided by their doctors according to approved guidelines and local recommendations for supportive medications. The study observes patients starting these treatments for the first time and follows their clinical course as they receive care in usual medical settings. During the study, researchers will collect data for up to approximately 60 months to understand how long patients continue treatment and other health outcomes. Data collection includes monitoring treatment use, clinical responses, and safety in a real-world context. Participants or their representatives must provide consent for data verification, and the study tracks outcomes during routine clinical visits without altering standard treatment practices.

Researchers are investigating sovateltide, a new drug that targets ETB receptors, for treating acute cerebral ischemic stroke (ACIS), a condition caused by a blocked blood vessel in the brain leading to brain tissue damage. ACIS is the most common type of stroke and a serious emergency with limited treatment options. Current standard treatment with tissue plasminogen activator (t-PA) has a narrow time window and limited success in fully resolving stroke effects. Sovateltide has shown promise in animal studies and early human trials by promoting brain repair and improving neurological outcomes. The study compares sovateltide treatment alongside standard care to a placebo (normal saline) in patients who recently experienced ACIS. Participants will receive the study drug within 24 hours of stroke symptom onset. This phase III trial is randomized, double-blind, and placebo-controlled, conducted across multiple centers in the United States, Canada, the United Kingdom, and Europe. The trial builds on positive results from earlier phase II and III studies conducted in India. Participants will be followed for 90 days after treatment to assess recovery using scales that measure disability and neurological function. Researchers will monitor safety and effectiveness by evaluating participants' abilities and stroke outcomes, including the modified Rankin Scale score. The trial aims to provide further evidence on whether sovateltide can improve recovery and function after acute ischemic stroke when added to standard treatment.

Researchers are evaluating the clinical safety and effectiveness of the DERIVO4heal4 Embolisation Device in treating intracranial aneurysms. This prospective, single-arm, multicenter, open-label study is conducted in Germany across approximately 15 sites. The study aims to assess mid- and long-term clinical and angiographic outcomes, focusing on potential risks and updating the device's clinical evaluation to ensure its safety and performance after market approval. Participants will receive flow diversion therapy using the DERIVO4heal4 Embolisation Device to treat their intracranial aneurysm. The study plans to enroll up to 158 patients over 36 months, followed by a 12-month observation period. The device will be implanted as part of standard clinical routine, and treatment success, safety, and technical performance will be systematically recorded. During the study, patients will have scheduled follow-ups to monitor clinical progress and safety, with key outcome assessments at approximately 6 weeks, 6 months, and 12 months. Data on clinical and safety endpoints will be collected and validated using electronic case report forms and monitored for accuracy. Personal data will be securely handled according to regulations, and study results will be shared with ethics committees and may be published with investigator agreement.

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 collecting new real-world data on first-line treatment for women newly diagnosed with advanced high-grade epithelial ovarian cancer in Germany. This study aims to understand how maintenance treatment with Poly ADP ribose polymerase inhibitors (PARPi) affects routine medical care, patient outcomes, and treatment sequences, especially in those undergoing surgery and chemotherapy. It also explores patient-reported experiences, physician insights, genetic testing practices, and drug safety in this setting. The study observes patients receiving first-line platinum-based chemotherapy, including those who have completed primary debulking surgery. It includes patients who have started or are planning to start chemotherapy, with the total number of chemotherapy cycles tailored by the treating physician. Women of childbearing potential must use reliable contraception during the study. The study does not involve any experimental interventions but monitors treatments as they occur in regular clinical practice. Participants will be followed to evaluate progression-free survival and other outcomes up to 84 months from the start of chemotherapy. Patient-reported outcomes will be collected electronically to capture experiences and needs during and after maintenance therapy. The study also tracks the use of BRCA/HRD testing, treatment safety, and physician experiences to better understand care patterns and long-term results in routine clinical settings.

Researchers are studying both early and advanced/metastatic breast cancer to improve therapy decisions and healthcare quality. Metastatic breast cancer patients often have the poorest prognosis, and there is a need to better understand tumor characteristics to guide targeted therapies. This study aims to establish methods for analyzing molecular features of tumors and metastases using blood samples, as tumor biopsies can be invasive and are not routinely performed despite recommendations. Participants will have blood samples taken during routine blood draws to analyze tumor expression, mutations, gene copy number changes, and other molecular markers. The study focuses on creating a comprehensive infrastructure for molecular assessment in breast cancer patients at different stages. The research also explores healthcare outcomes and economics to enhance patient integration and awareness. Participants will be monitored to discover biomarkers that predict progression-free survival in metastatic breast cancer and assess disease-free survival in early breast cancer over up to 60 months. The study involves routine clinical assessments and blood collections, with data collected on tumor characteristics and patient health outcomes. Overall participation spans long-term follow-up to evaluate progression and survival measures.

Researchers are evaluating the patient-reported outcomes, real-world efficacy, and safety of trastuzumab deruxtecan (T-DXd) in patients with HER2-positive, HER2-low, or HER2-ultralow unresectable or metastatic breast cancer receiving treatment according to the approved product guidelines in routine clinical practice in Germany. This prospective, non-interventional, multicenter study includes approximately 800 patients divided equally into HER2-positive and HER2-low/ultralow groups. Patients will also be informed about the use of a digital healthcare application (DiGA). Eligible patients must be receiving T-DXd as part of their routine care, with all diagnostic tests and treatment visits determined by their treating physicians and not by the study protocol. The study observes patients treated with T-DXd in line with the applicable summary of product characteristics. Treatment decisions, including visit frequency and procedures, follow standard clinical practice rather than study-mandated schedules. Participants will be followed to monitor the time from the first dose of T-DXd until the start of the next treatment or death, assessed for up to 60 months. Data collection will include patient-reported outcomes, safety information, and real-world clinical data. The study aims to gather comprehensive information on treatment effects and patient experiences during routine care without altering their treatment plan.

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.

Researchers are evaluating the effectiveness and safety of using the self-expandable CREDOae Heal Stent for permanent stenting in patients with acute ischemic stroke caused by large vessel occlusion. This treatment is studied after unsuccessful attempts to reopen the blocked vessel using thrombectomy. The study focuses on patients who have persistent vascular occlusion due to severe intracranial artery narrowing and aims to improve blood flow in the brain. The intervention involves rescue stenting with the CREDOae Heal Stent combined with the NeuroSpeed PTA Balloon Catheter. This device-based treatment is applied after at least one failed mechanical thrombectomy attempt using devices like stent retrievers or direct aspiration. The procedure targets arteries in either the anterior or posterior brain circulation and is considered suitable by the treating physician based on the patient's condition. Participants will be monitored for success of vessel reopening immediately after treatment and assessed for their clinical outcome around 90 days later, focusing on their level of disability. The study measures include technical success of the procedure and functional recovery using standard scales. Safety and efficacy will be closely observed, with eligibility including adults over 18 years with specific stroke characteristics and symptom onset within 24 hours before treatment.

This study is an exploratory, interventional, open label, single-arm, multi-centre prospective clinical investigation. In this post-market clinical investigation, the aim is to further evaluate the efficacy and safety of the iNstroke 4F aspiration catheter, with a view to, in future clinical investigations, comparing the product with the standard therapy or with other similar products. In addition, this clinical investigation will generate results that could be used to further assess the safety and effectiveness of mechanical thrombectomy for the treatment of DMVO.