Geldrop

Researchers are evaluating the effectiveness of the RISE blended behavioral intervention in people who have had a first stroke. The study aims to prevent major adverse cardiovascular events such as recurrent stroke, transient ischemic attack TIA, acute coronary events, and cardiovascular death over a one-year follow-up, compared to standard care. The study also examines the cost-effectiveness of the intervention and its impact on reducing sedentary behavior in community-dwelling stroke survivors with sedentary movement patterns. Participants are randomly assigned to either the experimental group receiving the 15-week RISE intervention alongside usual care or the control group receiving usual care only. The RISE intervention involves coaching by a primary care physiotherapist using behavior change techniques and the RISE eCoaching system, which includes an activity monitor, smartphone app with real-time feedback and e-learning modules, and a monitoring dashboard for the physiotherapist. Participants also receive support from someone in their social network. Usual care follows hospital-specific guidelines. Participants will be involved in baseline, post-treatment four months, and follow-up assessments at six, nine, and twelve months after randomization. These include wearing an activity monitor, completing questionnaires, and performing physical tests. Researchers measure major adverse cardiovascular events, 24-hour activity patterns including sedentary behavior, physical activity, and sleep, as well as cost-effectiveness, quality of life, healthcare utilization, and productivity losses. The study is designed to minimize burden with home or online sessions and non-invasive assessments, lasting approximately 3.5 hours per measurement period.

Researchers are studying lung cancer patients to improve diagnosis and monitoring using a blood test called liquid biopsy, which analyzes tumor markers, circulating tumor cells, and circulating tumor DNA ctDNA. This multicenter, prospective observational study aims to introduce up-front ctDNA analysis into routine diagnostic care for advanced lung cancer patients in the Southeast of the Netherlands. The study also seeks to develop and validate decision support models that predict imaging outcomes and patient survival, and to create a new test detecting PD-L1 expression on circulating tumor cells. The study involves collecting blood samples from patients suspected of lung cancer, with extra blood draws for those with advanced disease. These samples will be used to analyze ctDNA and tumor markers. The study will track how the introduction of ctDNA testing affects the number of tissue genetic tests performed and the time needed to make treatment decisions. Over up to three years, researchers will develop and validate models to support patient diagnosis and monitoring, including a test using super-resolution microscopy to detect PD-L1 on tumor cells. Participants will have blood drawn during routine visits, with up to 20 draws over a maximum of 36 months. Researchers will compare genetic information from blood tests to tissue analyses, measure how decision support models perform, and assess the timing of imaging and survival predictions. The study involves minimal risk from blood draws and aims to enhance personalized care by integrating new testing methods into clinical practice.

Researchers are evaluating whether customizing blood thinner treatment after hip or knee replacement surgery can reduce both blood clots and bleeding compared to the standard approach used for all patients. This study focuses on patients undergoing elective total hip or knee arthroplasty and aims to determine if shorter treatment is safe for low-risk patients and if higher doses for high-risk patients lower clot risks without causing too much bleeding. Participants are grouped based on their predicted risk of venous thromboembolism VTE using a risk score called TRiPplasty. Low-risk patients are randomly assigned to either a shortened prophylaxis during hospital stay only or standard treatment for about 4 weeks. High-risk patients are randomly assigned to receive intensified and extended prophylaxis for 6 weeks or standard treatment. Intermediate-risk patients participate in an observational arm without treatment changes. Treatments include types of blood thinners such as low molecular weight heparin or direct oral anticoagulants given according to Dutch guidelines. During the study, participants complete four questionnaires one before surgery, and at 2 weeks, 6 weeks, and 3 months after surgery to assess blood clots and bleeding events. An additional questionnaire at 1 year evaluates quality of life and joint function for those who experienced complications or a matched group. No extra hospital visits are required. Researchers will measure rates of venous thromboembolic events and major bleeding within 90 days, along with other health outcomes and patient-reported quality of life.

Researchers are evaluating the use of the ENDORISK Bayesian network model to improve preoperative risk assessment for lymph node metastasis in patients with early stage endometrial cancer. This study aims to see if implementing ENDORISK in everyday clinical practice enhances risk stratification compared to the current standard care. The study also looks at patient information sharing, treatment decisions, survival outcomes, quality of life, clinician experiences, and healthcare costs. Participants are divided into two groups a control group receiving standard care based on prior data, and an intervention group using the ENDORISK model to receive personalized risk assessments and treatment plans including hysterectomy with or without lymph node surgery. The model is applied during preoperative counseling to guide treatment decisions. The study is conducted over several years in two oncology regions, with the intervention introduced sequentially. During the study, participants will undergo lymph node staging if indicated, and complete questionnaires about information provision and shared decision-making up to 12 weeks after surgery. Researchers will monitor the proportion of patients choosing lymph node assessment, positive predictive value of detected metastases, survival rates over 5 years, health-related quality of life at 12 weeks and 12 months, treatment-related morbidity, clinician feedback, and regional care costs. The study starts in October 2025 and continues through October 2032.

Researchers are investigating how various factors beyond tumor stage, such as biochemical, histopathological, genomic, environmental, and clinical characteristics, affect the outcomes of patients diagnosed with colorectal cancer CRC, small bowel cancer, and anal cancer. This observational study aims to collect detailed information from diagnosis through long-term follow-up to better understand prognosis and treatment effects in both early and late-stage cancers. The study addresses the gap between clinical trial populations and real-world patients by including a broader patient group treated in general practice. Participants will be followed prospectively from their initial diagnosis until death. Data collection includes medical history, clinical parameters, imaging, pathology, tumor details, treatments, hospital stays, interventions, and adverse events. With separate consent, patient-reported quality of life and work ability information will also be gathered. Additionally, biological samples obtained during routine care may be collected for further observational and molecular research. This cohort serves as a platform for evaluating new interventions through a Trials within Cohorts TwiCs design. Throughout up to ten years of follow-up, participants will undergo assessments of progression-free survival, disease-free survival, overall survival, and serious adverse events. Quality of life and work ability are assessed at intervals of 3, 6, 12, 24, 36, and 48 months. This extensive data collection supports a wide range of research aims including prognostic studies, molecular analyses, comparisons of new treatments, and health policy evaluations. The study provides a comprehensive view of treatment outcomes and patient experiences in everyday clinical settings.

Researchers are evaluating AGN1 LOEP, a local osteo-enhancement procedure, to prevent secondary hip fractures in osteoporotic women who have already had an initial hip fracture and surgery. This randomized controlled trial involves postmenopausal women aged 65 to 91 years who experienced a low-energy fragility hip fracture. The study aims to reduce the chance of a second hip fracture by comparing the new treatment to standard care alone. Participants will be randomly assigned to one of two groups the treated group receives standard hip fracture repair plus the AGN1 LOEP procedure on the opposite unfractured hip, while the control group receives standard repair without the AGN1 LOEP treatment. The AGN1 LOEP procedure involves injecting implant material into the unfractured hip immediately after surgery. This study is single-blinded, except in Canada where it is not blinded. Participants will attend scheduled follow-up visits at 6 weeks, 6 months, and every 6 months thereafter for at least 5 years. During these visits, researchers will monitor for new hip fractures, adverse events, and measure bone mineral density at 12 and 24 months. The study will assess the cumulative incidence of secondary hip fractures and safety outcomes over time, with a minimum follow-up of 5 years after the initial hip repair surgery.