Roermond

Researchers are evaluating a shorter treatment duration with androgen receptor pathway inhibitors ARPIs, specifically Apalutamide or Enzalutamide, in patients with low-volume hormone-sensitive metastatic prostate cancer. This phase 3 clinical trial aims to determine if stopping ARPI therapy after 12 months, with the option to restart if the cancer progresses, is not worse than continuing ARPI treatment. The goal is to reduce side effects and costs while maintaining effective disease control. Participants will be randomly assigned after completing 12 months of ARPI treatment to one of two groups one group will continue androgen deprivation therapy ADT combined with ARPI, while the other will stop ARPI after 12 months but may restart it if a confirmed rise in prostate-specific antigen PSA occurs. The PSA confirmation sample must be taken at least four weeks after the initial rise. Treatment will be monitored closely according to these protocols. During the study, participants will be followed for up to 6 years, including 5 years after randomization to track clinical progression-free survival. Researchers will regularly assess disease status, treatment effects, and possible side effects. The study includes regular visits and monitoring to evaluate how long patients remain free from disease progression while comparing the two treatment approaches.

Researchers are evaluating the long-term safety and effectiveness of periodic adalimumab as an initial treatment for newly diagnosed Crohns disease CD patients. The study compares this approach to the standard step-up care that begins with corticosteroids. The goal is to improve treatment outcomes and reduce side effects by avoiding overtreatment, especially since current markers cannot predict disease progression at diagnosis. This trial addresses the limitations of existing therapies, such as delayed use of disease-modifying biologicals and risks associated with combination treatments. Participants are randomly assigned to one of two groups one receives episodic subcutaneous adalimumab monotherapy for 6 months as the first-line treatment, while the other follows the standard step-up care starting with corticosteroids. This study is a phase 4 trial that focuses on comparing these two treatment strategies over time, with detailed monitoring of drug effects and disease progression. During the study, participants will be closely monitored through clinical visits, imaging tests like ileo-colonoscopy and small bowel MRI or CT-enterography, and use of the myIBDcoach app for remote monitoring. Researchers will assess the number of yearly quarters of corticosteroid-free remission at week 96 as the primary outcome. Additional measures include bowel damage progression, adverse events, corticosteroid use, endoscopic remission, time to remission, quality of life, and healthcare costs. The total study duration includes assessments at weeks 24, 48, and 96 to capture both short- and long-term effects of the treatments.

Researchers are evaluating chemotherapy dosing strategies in older patients aged 70 years and above who have metastatic colorectal cancer and are eligible for first-line palliative chemotherapy. This phase III randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard full-dose chemotherapy, focusing on progression-free survival PFS. Patients are assessed using the Geriatric 8 G8 questionnaire to determine their risk of chemotherapy toxicity, which guides treatment assignment. The study seeks to balance treatment effectiveness with minimizing toxicity, hospital admissions, and maintaining quality of life QoL and physical functioning. Participants classified as low risk for toxicity G8 score 15 or higher are randomized to receive either doublet chemotherapy a fluoropyrimidine combined with oxaliplatin at full dose or with a 25% dose reduction upfront. Those at high risk G8 score 14 or lower or judged high risk by their oncologist receive fluoropyrimidine monotherapy either at full dose or with a 25% dose reduction. The study also allows the addition of targeted treatments like bevacizumab or EGFR inhibitors. Dose adjustments are made for patients with moderate kidney impairment. Chemotherapy is given orally or intravenously on schedules varying between every two and three weeks, depending on the regimen. Participants will be closely monitored throughout treatment, with assessments including radiological or clinical evaluations for disease progression, quality of life and physical functioning questionnaires at 1, 3, 6, and 12 months, and tracking of chemotherapy toxicity, overall survival, treatment cycles, dose changes, hospital admissions, and cumulative drug dosage. Safety and cost-effectiveness will also be evaluated over an average study duration of eight months and up to one year for some outcomes. The study plans to include 587 patients and will continue until December 2028.

Researchers are investigating whether voice recordings or capnometry measurements, alone or combined with other non-invasive biomarkers, can detect emphysema on chest CT scans in people with chronic obstructive pulmonary disease COPD. The study aims to develop a machine-learning algorithm to classify the extent of emphysema using features from speech and capnometry data. This research is observational and focuses on patients diagnosed with COPD with related respiratory symptoms and CT imaging results. Participants will perform various voice tasks such as paced reading, sustained vowels, coughing, and quiet breathing. Capnometry measurements will be taken before and after a light exercise task, specifically the 5-sit-to-stand test. These procedures will be done in a single clinic visit. Clinical data including lung function tests and CT scans are already collected as part of routine care. The study will analyze voice and capnometry data using machine learning models to classify emphysema severity. During the visit, participants will complete voice-related tasks and capnometry tests, perform a short exercise, and have blood drawn. Researchers will measure outcomes including emphysema extent on CT scans, various voice features, and capnography parameters. Additional lung function measures and serum biomarkers will also be reviewed. The study monitors data quality and uses statistical models to explore how well these non-invasive measures predict emphysema. Participation involves a single visit with no intervention treatment.

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 treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

Researchers are evaluating the impact of a combined exercise and nutrition program on quality of life in patients with incurable gastroesophageal adenocarcinoma, particularly after their first-line cancer treatment has failed. This study focuses on patients with metastatic or recurrent disease, aiming to address declines in muscle mass, physical ability, and nutritional health, which can worsen quality of life. The trial seeks to understand whether improving physical capacity and nutrition can benefit patients in this challenging condition. Participants will be randomly assigned to one of two groups one receiving standard medical care, including nutritional support and general advice on physical activity the other receiving this usual care plus a 12-week intervention involving supervised exercise sessions twice weekly with an oncology physiotherapist and biweekly nutritional assessments by a dietician. The exercise includes aerobic and resistance training tailored to individual fitness, alongside education to increase daily activity, supported by activity trackers. Nutritional guidance follows established cancer-related nutrition guidelines, emphasizing protein intake post-exercise. Throughout the study, participants will complete questionnaires on quality of life at baseline, 6 weeks, and every 12 weeks up to one year. Measures such as aerobic capacity, muscle strength, body composition, nutritional status, physical activity levels, and treatment effects will be regularly assessed. The trial also monitors treatment toxicity, progression-free and overall survival, and performance status. The full observation period extends up to one year after the intervention, ensuring comprehensive evaluation of outcomes and safety.