Drachten

This research investigates treatments for metastatic castration-resistant prostate cancer mCRPC focusing on a drug called ifinatamab deruxtecan I-DXd. The study aims to assess the safety, how well participants tolerate the treatments, and appropriate dosing levels of I-DXd alone or combined with other therapies. Researchers will also monitor participants prostate specific antigen PSA levels during treatment to understand its effects. Participants are assigned to one of several treatment groups. One group receives docetaxel every three weeks for up to 10 cycles. Other groups receive I-DXd alone or combined with either opevesostat or androgen receptor pathway inhibitors such as abiraterone acetate or enzalutamide. I-DXd is given every three weeks until unacceptable side effects, disease progression, death, or withdrawal, while the other drugs continue until specific discontinuation criteria are met. Premedication is required before each I-DXd dose to prevent nausea and vomiting. Throughout the study, participants undergo various assessments including monitoring of dose-limiting toxicities, adverse events, and PSA response rates. Researchers also track objective response rates, progression-free survival, overall survival, and other clinical outcomes over up to approximately 54 months. The study involves regular evaluations to assess safety and treatment effects until study completion.

This research aims to evaluate whether preventive endovascular stenting of a significant narrowing over 50% in the superior mesenteric artery SMA can reduce the risk of anastomotic leakage AL after elective colon surgery. AL is a serious complication linked to higher mortality, lower quality of life, and increased healthcare costs. A prior study showed that having more than 50% SMA stenosis raises the risk of AL sixfold, and this trial investigates if stenting this artery before surgery can help prevent AL. Participants are randomly assigned to one of two groups the intervention group will receive preventive angioplasty and placement of a covered stent in the SMA before their colon surgery, while the control group will proceed with colon surgery without stenting. Both groups receive daily mono antiplatelet therapy with carbasalate calcium, lifelong for the intervention group and at least 12 months for the control group. The stenting procedure is minimally invasive and performed preferably within two weeks before surgery at specialized centers. Colon surgery is done according to standard local guidelines. Some centers will use intraoperative fluorescence angiography to assess blood flow during surgery. During the 12 months of follow-up after surgery, participants will be monitored for anastomotic leakage within the first 90 days, as well as delayed leakage and surgical complications up to one year. Researchers will collect data on hospital stays, reinterventions, mortality, quality of life, healthcare costs, and stent function. Patient-reported outcomes will be gathered through questionnaires at multiple time points. The study also includes imaging assessments and cost-effectiveness analyses to understand the broader impact of preventive stenting.

Researchers are investigating how to best measure changes in swelling and other characteristics of lower limb lymphedema after treatment. This study aims to identify which tools can reliably detect meaningful changes in edema features such as limb volume, skin hardness, and water content during intensive and maintenance treatment phases. Understanding these measurement criteria is important to accurately assess patient progress and treatment effects. Participants include patients with lower limb lymphedema who are either about to start intensive decongestive lymphatic therapy or are in the maintenance phase after completing intensive treatment at least three months prior. Each participant will undergo two clinical evaluations spaced one month apart using a set of reliable and feasible measurement methods selected by experts. These assessments will focus on various edema characteristics to evaluate treatment effects. During the study, participants will be evaluated on limb volume, skin hardness, pitting status, skinfold thickness, extracellular fluid, and functional problems related to lymphedema. The main outcomes measured are the sensitivity, specificity, and diagnostic accuracy of these evaluation methods after one month. This observational study will help establish clear criteria for clinical changes in lower limb lymphedema, supporting better treatment evaluation and patient care.

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 studying the gut microbiome in adults with metastasized or irresectable colorectal cancer CRC who are receiving chemotherapy. The study aims to understand how the gut microbiome changes during treatment and how these changes relate to the effects of chemotherapy. This research is important because even though treatments are improving, survival rates remain low and side effects are common, so better tools to predict treatment response are needed. Participants in this observational study will provide fecal samples at home before starting treatment and again three months after treatment begins, coinciding with their response evaluation. They will also fill out questionnaires about factors that may affect the microbiome, such as the use of antibiotics or proton pump inhibitors. Additionally, blood samples will be collected before treatment and three months later for storage and analysis. During the study, researchers will track participants response to chemotherapy and any serious side effects over two years. They will use various tests, including stool sample analysis, questionnaires, and blood tests, to gather data. The total duration of participation and follow-up extends for at least two years to help predict treatment outcomes and side effects based on microbiome changes.

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 studying the use of targeted anticancer drugs in patients with advanced cancer who have specific molecular changes in their tumors. This study aims to describe how well these targeted drugs work and their side effects when prescribed based on a tumors genetic or protein profile. It focuses on patients with advanced solid tumors, multiple myeloma, or B cell non-Hodgkin lymphoma who have no standard treatment options left and have acceptable health status and organ function. Participants receive targeted cancer drugs selected from a list of approved therapies matched to their tumors molecular profile. A molecular tumor board and study coordinators help determine the best drug choice. Before treatment, patients provide a fresh tumor biopsy for genetic analysis. The study includes many drugs, including Panitumumab, Olaparib, Dabrafenib, and several others, some given alone or in combination, according to the tumor profile. Treatment eligibility and drug-specific criteria are confirmed before starting therapy. Throughout the study, participants are monitored for tumor response, disease stability, survival, and treatment side effects. Researchers collect data on tumor changes, progression-free survival, overall survival, and how long patients remain on treatment. Next generation sequencing on tumor samples provides additional biomarker information. The study continues to follow patients for up to one year after treatment to assess outcomes and safety.