Offenburg

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.

This research aims to evaluate the effectiveness of trastuzumab deruxtecan (T-DXd) in adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have previously been treated with a trastuzumab-based regimen. The study also collects patient demographic and clinical information, treatment patterns, and safety data including serious adverse events and drug reactions. It includes a disease registry for patients receiving conventional therapies in a real-world European setting. The study is non-interventional, meaning no investigational drugs are administered beyond standard care. Patients receiving T-DXd will be treated according to the Summary of Product Characteristics (SmPC), and data on conventional therapies such as platinum-fluoropyrimidine chemotherapy, nivolumab, ramucirumab-paclitaxel, taxane, irinotecan, and pembrolizumab will also be gathered. Treatment choices and administration follow the physician's decision and routine clinical practice. Participants will be monitored from baseline to about two years to assess the time to next treatment. Researchers will collect clinical data, treatment details, tolerability, and patient surveys to understand outcomes and safety. The study involves regular follow-up and data collection to track treatment effectiveness and patient experience in real-world settings.

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy). The planned duration of treatment in either arm of the study is 7 years. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs). Patients will be followed for 10 years from randomization of the last patient.

Researchers are studying metastatic colorectal carcinoma (mCRC) patients whose tumors have a BRAFV600E mutation, which is known to have a poorer outlook compared to non-mutated cases. Standard treatments after the first therapy have shown limited success, with low response rates and short survival times. This study aims to understand how the combination of encorafenib and cetuximab works in real-world settings, focusing on effectiveness, quality of life, safety, and tolerability in German, Austrian, and Swiss patients who have already received prior therapies. Participants will receive encorafenib combined with cetuximab, treatments that target specific cancer mutations. This study is observational and non-interventional, meaning it records how patients respond to these drugs in routine care without altering their treatment. The study allows initial retrospective data collection and will follow patients longitudinally to gather comprehensive information about their experiences with the therapy. During the study, patients will be monitored for overall survival twelve months after starting treatment. Researchers will assess how well the treatment controls the cancer, side effects experienced, and patients' quality of life. Data will be collected from medical records and patient reports in regular clinical care, providing insights into the real-life use and impact of encorafenib and cetuximab for this patient group.

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.

Immune thrombocytopenia (ITP) is a rare blood disorder where the immune system causes a shortage of platelets, leading to increased bleeding risk. New treatment options have emerged recently, but clinical studies often focus on specific patient groups. This research collects real-world data from a broad range of ITP patients to better understand the diagnosis, treatment, and outcomes in everyday care. The study also aims to improve personalized therapy and patient results by gathering detailed clinical and biospecimen information. The study involves creating a national registry where clinical data and biospecimens are collected from patients diagnosed with primary or secondary ITP. Data are gathered prospectively at defined points during the disease course, and patients can also be included retrospectively within 12 months of diagnosis if ongoing documentation is available. This includes information about disease factors, treatment types, complications, quality of life, fatigue, and survival over 5 years. Participants will provide written consent and undergo clinical assessments at enrollment and follow-up visits. Researchers will collect epidemiological data such as disease incidence, age and sex distribution, causes, treatment types, and remission status over 5 years. The registry also includes biospecimen collection to support high-quality, standardized research. This ongoing monitoring will help improve knowledge of ITP and support better patient care.

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 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 evaluating the use of venetoclax combined with induction and consolidation chemotherapy in adults newly diagnosed with acute myeloid leukemia (AML) or myelodysplastic syndrome with excess blasts-2 (MDS-EB-2). This phase III, multicenter, double-blind, randomized, placebo-controlled study aims to establish the effectiveness and safety of adding venetoclax to standard chemotherapy compared to placebo. The study includes a feasibility run-in dose-escalation phase to determine the appropriate venetoclax dose for the main phase 3 trial. Eligible patients will first enter a dose-escalation phase if applicable, then be randomized to receive either venetoclax or placebo along with intensive chemotherapy. Treatment includes two induction chemotherapy cycles with cytarabine and daunorubicin, followed by consolidation chemotherapy based on age and response. Patients achieving complete remission or morphologic leukemia-free states may continue consolidation therapy. Some patients may also proceed to allogeneic stem cell transplantation based on institutional guidelines and individual factors. Participants will be closely monitored for events such as survival without leukemia relapse and treatment toxicities over 6 and 16 months. Safety assessments include tracking dose-limiting toxicities during the first treatment cycle. The study also involves molecular testing, kidney and liver function tests, and adherence to contraceptive measures for participants of childbearing potential. The total study participation duration varies based on treatment response and follow-up needs.