Dirksland

Researchers are evaluating the effectiveness of camizestrant compared to standard endocrine therapy in patients with early breast cancer that is estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-). These patients have an intermediate or high risk of cancer recurrence and have already completed local treatments such as surgery and possibly chemotherapy, alongside at least 2 years and up to 5 years of standard adjuvant endocrine therapy. The study is a Phase III, open-label trial designed to assess outcomes over a long term. Participants will be randomly assigned to receive either camizestrant, an oral selective estrogen receptor degrader, or one of several standard endocrine therapies including tamoxifen, anastrozole, letrozole, or exemestane, administered according to local approved guidelines. The treatment duration for both groups is planned to last 60 months. Eligible patients may have previously used CDK4/6 inhibitors, and the study will specifically include those with intermediate or high risk of recurrence as determined by clinical and biological markers. During the study, participants will be monitored for up to 10 years from the last patient's randomization to evaluate invasive breast cancer-free survival. Additional outcomes include invasive disease-free survival, distant relapse-free survival, overall survival, safety, and clinical outcome assessments. The study involves ongoing assessments of health status, treatment effects, and safety to determine the long-term benefits and risks of camizestrant compared to standard therapies.

Researchers are evaluating the effects of the drug orforglipron compared with a placebo on cardiovascular outcomes in adults who have atherosclerotic cardiovascular disease (ASCVD) and/or chronic kidney disease (CKD). This is a Phase 3, randomized, double-blind, placebo-controlled study designed to investigate major adverse cardiovascular events over a long period. Participants will receive either orforglipron or a placebo orally. The study is event-driven and will continue until the occurrence of major cardiovascular events or up to about 5 years. The treatments are administered without revealing to participants which group they are in to ensure unbiased results. During the study, participants will be monitored for the time to the first occurrence of a major cardiovascular event. Researchers will collect data from baseline through the end of the study, which lasts approximately 5 years. Regular assessments will help evaluate the safety and effects of the treatments on cardiovascular health in this population.

Researchers are investigating the effectiveness of adding liothyronine (LT3) to levothyroxine (LT4) treatment in patients with autoimmune hypothyroidism who continue to experience significant tiredness despite normalized thyroid hormone levels on LT4 alone. This phase 3 trial addresses the issue that LT4 monotherapy may not achieve the natural balance of thyroid hormones, as some patients still feel tired. The study also explores genetic factors that might influence treatment response. The study begins with a run-in period where all participants switch to a standardized LT4 preparation to stabilize thyroid hormone levels. During this 4-8 month period, doses are adjusted to maintain normal TSH levels, and patients with unstable TSH or heart abnormalities are excluded. Those with persistent tiredness and stable hormone levels then enter a 1-year double-blind randomized trial, receiving either LT4 combined with LT3 or LT4 with placebo. Regular visits occur at baseline and weeks 8, 16, 26, 39, and 52, including dose adjustments and comprehensive assessments. Participants complete questionnaires about tiredness, quality of life, and medical resource use at every visit. Additional blood tests for genetics and thyroid metabolites occur at baseline and 52 weeks, along with monitoring of bone, cardiovascular, metabolic, and brain health through scans, ECGs, and neurocognitive tests in subgroups. The main outcome is the change in tiredness scores over 52 weeks, with safety and treatment effects closely monitored throughout the study.

Researchers are studying breast cancer patients who have cancer that has spread to lymph nodes and are treated with neoadjuvant systemic therapy (NST), which includes chemotherapy and sometimes immunotherapy. The study focuses on how to best check and treat the lymph nodes after NST, comparing less invasive methods to the traditional axillary lymph node dissection (ALND). The goal is to see if less invasive techniques can offer similar cancer control and quality of life benefits. This multicenter observational study includes patients with positive lymph nodes who receive NST followed by breast and axillary treatment. Data on patient characteristics, tumor details, staging before and after NST, and treatments will be collected into a national database. Patients will complete quality of life questionnaires at diagnosis, and then 1 and 5 years later to understand the impact of different axillary treatment strategies. Participants will be followed for 5 years to evaluate disease-free survival, breast cancer-specific survival, overall survival, and rates of cancer returning in the lymph nodes. Quality of life will be measured using multiple questionnaires over time. The study aims to provide evidence to improve national guidelines and support shared decision-making about axillary treatment options for node positive breast cancer patients.

Researchers are studying patients diagnosed with colorectal cancer, small bowel cancer, and anal cancer to better understand factors that affect treatment outcomes and survival. This study looks beyond tumor stage to explore how biochemical, genetic, environmental, and clinical factors may influence tumor recurrence and patient survival. It aims to address the gap in knowledge caused by most cancer patients not participating in clinical trials, and to validate trial results in a broader patient population. This is a prospective observational cohort study where data is collected from patients starting at their primary diagnosis and continuing until death. After informed consent, researchers gather detailed information on medical history, clinical status, imaging, pathology, tumor characteristics, treatments, hospital stays, side effects, and adverse events. Additional consent allows collection of patient-reported outcomes on quality of life and work ability, as well as biological materials like blood and tumor tissue for research and biobanking. Participants will be closely followed over time with ongoing data collection on treatment effects, clinical outcomes, and patient experiences. The study aims to provide accurate real-world data on various treatments and outcomes and to serve as a resource for future research into prognostic markers, new therapies, molecular studies, and health care policy. The main outcome measured is progression-free survival, tracked for up to 10 years, to better understand long-term treatment impact.

Researchers are evaluating the effect of at-home taste steering compared to standard care on food enjoyment in patients with metastatic triple negative breast cancer, metastatic testicular cancer, or stage II-IV diffuse large B cell lymphoma who are starting chemotherapy. This multicenter, non-blinded randomized intervention trial uses a parallel cluster design across 12 hospitals in the Netherlands to prevent bias from patient contact between study arms. The study aims to measure outcomes before chemotherapy, at the onset of taste or smell changes, and after six weeks of intervention. The study involves two groups: an intervention group receiving taste steering at home and a control group receiving usual care. Taste steering is a behavioral intervention conducted in the patient's home. Patients complete online questionnaires at home, while taste and smell tests and saliva samples are collected either at home or during hospital visits. Both groups receive contact from their dietitian every three weeks. The intervention period is six weeks, based on previous experience that the taste steering algorithm reaches saturation after three to four weeks. Participants will be assessed at baseline before chemotherapy, at the time taste or smell alterations occur, and after six weeks. Data collected include food enjoyment, taste and smell test results, saliva samples, and questionnaire responses. The study monitors participants' adherence and outcomes during regular hospital visits and at-home assessments. The total involvement includes initial and follow-up evaluations over the six-week intervention period.

Researchers are evaluating the effects of at-home taste and smell training compared to standard care on taste function in patients with cancer who are treated with tyrosine kinase inhibitors. This multicenter randomized intervention trial is conducted at 12 hospitals in the Netherlands using a parallel cluster design to avoid bias from patient interaction within hospitals. The study focuses on participants aged 18 to 70 years who experience taste alterations after starting tyrosine kinase inhibitor treatment. Participants are assigned to either an at-home taste and smell training group or a control group receiving usual care. The intervention lasts 12 weeks, with measurements taken before the training begins and after 12 weeks. Questionnaires are completed online at home, while taste and smell tests along with saliva collection occur at home or in the hospital during regular visits. Both groups receive contact from their dietitian every 3 weeks. Throughout the study, researchers monitor taste function as the primary outcome over 12 weeks. Participants complete various assessments including questionnaires, taste and smell tests, and saliva collection. The study ensures adherence through regular dietitian contacts and facilitates data collection at home or hospital visits. The total participation period covers baseline assessment, a 12-week intervention or usual care phase, and follow-up measurements.