Uden

Researchers are evaluating the efficacy and safety of tulisokibart in participants with moderately to severely active Crohns disease. This program includes two studies Study 1 involves both induction and maintenance treatment phases, while Study 2 focuses only on induction treatment. The main goal is to determine if one or more doses of tulisokibart are more effective than placebo in achieving clinical remission and endoscopic response at various time points up to Week 52. Participants are randomly assigned to receive different dosing regimens of tulisokibart or placebo. These regimens include high or low doses administered intravenously followed by subcutaneous injections, or subcutaneous injections alone. Some participants may continue in an extension phase receiving subcutaneous doses after completing their original treatment arm if they meet specific requirements. The studies use a double-blind design to compare tulisokibarts effects against placebo. During the trial, participants undergo regular assessments to measure clinical remission, endoscopic response, and other health outcomes using tools like the Crohns Disease Activity Index and stool frequency with abdominal pain scores. Safety evaluations include monitoring adverse events and treatment discontinuations. The studies last up to 52 weeks for Study 1 and 12 weeks for Study 2, with multiple visits to assess treatment effects and participant health under medical supervision.

Researchers are studying patients with non-metastatic stage II colon cancer who are part of the Dutch ColoRectal Cancer cohort PLCRC and who consented to additional blood samples. The study aims to evaluate how many patients with detectable circulating tumor DNA ctDNA after surgery begin adjuvant chemotherapy. This observational and interventional trial includes patients who do not have a standard indication for chemotherapy and involves a randomized design to compare ctDNA-guided treatment with standard care. Patients are randomly assigned to one of two groups the ctDNA-based treatment group or the standard care group. In the ctDNA group, blood samples taken after surgery are analyzed for ctDNA. Those with detectable ctDNA are offered 3 months of adjuvant chemotherapy using CAPOX a combination of fluoropyrimidine and oxaliplatin. Patients without detectable ctDNA receive routine follow-up care. The standard care group receives routine follow-up without knowledge of their ctDNA results. Participants will have blood collected before surgery, after surgery, and during follow-up. Researchers will monitor who starts chemotherapy within 8 to 12 weeks after surgery and will track recurrence rates, disease-free survival, overall survival, time to recurrence, quality of life, and cost-effectiveness over several years. Follow-up assessments occur up to 10 years, allowing detailed long-term evaluation of treatment impact and patient outcomes.

Researchers are studying whether adjuvant chemotherapy can prevent disease recurrence in adults with high-risk rectal cancer who have detectable circulating tumor DNA ctDNA after surgery. The study aims to determine if this chemotherapy improves disease-free survival compared to standard care. Rectal cancer remains a significant cause of mortality, and while current treatments reduce local recurrence, distant recurrence rates stay high. Identifying patients with residual disease through ctDNA may help target those who might benefit from additional chemotherapy. Participants with detectable ctDNA after surgery will be randomly assigned to receive either standard care or adjuvant chemotherapy consisting of 6 cycles of FOLFOX 5FUfolinic acid and oxaliplatin every 2 weeks or 4 cycles of CAPOX capecitabine and oxaliplatin within 8 to 12 weeks after surgery. The chemotherapy treatment lasts about 3 months. The study is conducted within a prospective colorectal cancer cohort using a randomized controlled design. During the study, participants will have blood samples taken and visits with their physicians before each chemotherapy cycle if assigned to treatment. Researchers will monitor disease-free survival, overall survival, and quality of life using questionnaires over several years. They will also assess the clearance of ctDNA after chemotherapy and study its presence at recurrence. The total follow-up includes up to 2 years for disease recurrence and up to 5 years for survival outcomes.

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 studying obefazimod to evaluate its effectiveness and safety as a treatment for adults with moderately to severely active Crohns disease who have not responded well or cannot tolerate conventional or advanced therapies. This Phase 2b trial compares obefazimod with a placebo to see if it can help control symptoms and improve disease activity. The study also aims to assess the long-term safety and tolerability of obefazimod during an extension period. The study includes three treatment phases a 12-week induction phase, a 40-week maintenance phase, and a 48-week extension phase. Participants receive one of four daily treatments obefazimod at doses of 50mg, 25mg, or 12.5mg, or a placebo. All treatments are taken once daily, ideally in the morning with food. The extension phase focuses on monitoring safety and tolerability compared to placebo. Participants will attend regular study visits for assessments including the Crohns Disease Activity Index and endoscopic scores to measure disease activity and response. Safety is monitored through adverse event reports and laboratory tests, including blood work for hematology, coagulation, and biochemistry at various weeks up to the end of the study. The total study duration spans several phases, allowing close observation of treatment effects and safety over time.

Researchers are investigating whether taking breaks from the standard combination therapy of daratumumab, lenalidomide, and dexamethasone Dara-Rd for newly diagnosed multiple myeloma patients affects survival and quality of life. This study aims to compare continuous treatment versus planned treatment-free intervals to see if stopping therapy temporarily may reduce side effects, allow recovery from toxicity, and improve overall well-being while controlling the disease. Participants who have completed 12 cycles of Dara-Rd with at least a partial response and no signs of disease progression will be randomly assigned to one of two groups. One group will continue Dara-Rd therapy without interruption until disease progression, while the other group will stop treatment temporarily and restart it at biochemical progression, continuing until disease progression. The trial is open-label and will follow patients for several years to assess outcomes. Throughout the study, researchers will monitor participants event-free survival and progression-free survival for up to about 57 and 69 months, respectively. Additional assessments include side effect burden, patient-reported quality of life, treatment costs, treatment-free interval length, response times, and survival after second-line therapy. Regular evaluations will help determine how treatment interruption affects toxicity, dose intensity, and overall treatment outcomes over the long term.

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 evaluating two diagnostic approaches for patients suspected of having muscle-invasive bladder cancer MIBC. This trial compares the standard care method, Transurethral Resection of the Bladder Tumor TURBT, with a newer approach using multiparametric MRI mpMRI followed by a same-day cystoscopic bladder biopsy. The study aims to assess progression-free survival, time to definitive treatment, and cost-effectiveness over two years. Participants will be randomly assigned to one of two groups one undergoing mpMRI plus same-day cystoscopic bladder biopsy, and the other receiving TURBT with blood samples taken shortly before and after the procedure. Both groups will be monitored and compared for their diagnostic outcomes and related healthcare costs. Throughout the study, participants will have regular evaluations including assessments of progression-free survival, quality of life, healthcare costs, and circulating tumor cells before and after TURBT. The main outcome measure is progression-free survival at two years. The study involves multiple centers and aims to provide detailed information on the effectiveness and cost implications of these diagnostic strategies.

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 trastuzumab deruxtecan T-DXd for adults with unresectable or metastatic breast cancer that is either HER2-low or HER2 IHC 0. This includes patients with hormone receptor-negative and hormone receptor-positive types. The study aims to assess the safety and effectiveness of T-DXd, focusing on how long patients benefit from this treatment before needing the next anticancer therapy. Participants receive T-DXd intravenously at a dose of 5.4 mgkg on the first day of each 21-day cycle. Treatment continues until disease progression, unacceptable side effects, other criteria for stopping, or two years after the first dose. The study includes four groups based on hormone receptor status and HER2 classification, with participants having had one to two prior treatments for metastatic breast cancer. During the study, participants will have regular assessments including imaging scans to measure tumors, blood tests to monitor organ function, and questionnaires to evaluate quality of life. Researchers will track the time to next treatment, progression-free survival, response rates, adverse events, and changes in patient-reported outcomes for up to 24 months. Safety monitoring and close follow-up will support participant well-being throughout the trial.