Scheemda

Researchers are investigating the use of circulating tumor DNA (ctDNA) tests to improve personalized treatment decisions for patients with stage III non-small cell lung cancer (NSCLC). Current methods to determine who needs additional treatment after initial therapy are not optimal, leading to some patients receiving too much or too little therapy. The GUIDE.MRD consortium aims to establish a reliable standard for ctDNA tests by assessing their clinical utility and comparing the performance of different diagnostics at key treatment time points. The study includes patients with stage III NSCLC undergoing curative treatments such as chemo-radiotherapy followed by adjuvant immunotherapy, neoadjuvant treatment followed by surgery or radiotherapy, or surgery followed by adjuvant chemotherapy and immunotherapy. Blood samples will be collected at multiple landmark times including baseline, post-neoadjuvant treatment, post-surgery or chemoradiotherapy, post-adjuvant therapy, and at study end or disease progression. The ctDNA tests will be analyzed retrospectively without influencing current treatment decisions. Participants will provide clinical plasma samples to evaluate the accuracy of ctDNA diagnostics in detecting minimal residual disease, monitoring treatment response, and predicting relapse. The study will measure sensitivity, specificity, and predictive values of the tests, as well as the timing between ctDNA detection and clinical recurrence. Follow-up includes assessing three-year recurrence-free survival and response to therapies. Sample collection occurs up to 8 months after recruitment ends, supporting long-term monitoring of ctDNA performance.

Researchers are evaluating chemotherapy dosing strategies for older patients aged 70 years and above who have metastatic colorectal cancer and are candidates for palliative chemotherapy. This phase III, open-label, randomized controlled trial aims to compare upfront dose-reduced chemotherapy with standard full-dose chemotherapy to see if the reduced dose is not worse in terms of progression-free survival (PFS). The study also examines secondary outcomes including severe toxicity, quality of life, physical function, overall survival, treatment cycles, dose reductions, hospital admissions, cumulative dosage, and cost-effectiveness. Participants are classified based on their risk of chemotherapy toxicity using the Geriatric 8 (G8) questionnaire. Those at low risk are randomized to receive either full-dose or 25% dose-reduced doublet chemotherapy (a fluoropyrimidine combined with oxaliplatin). Patients at high risk receive either full-dose or dose-reduced monotherapy with a fluoropyrimidine. Targeted treatments like bevacizumab or EGFR inhibitors may be added. Dose adjustments are made for moderate kidney impairment. Treatments are given on schedules involving oral and intravenous chemotherapy drugs administered every 2 to 3 weeks. During the study, participants undergo assessments including clinical evaluations, laboratory tests to monitor blood counts and organ function, and questionnaires for quality of life and physical functioning. Progression-free survival is tracked for at least one year after randomization. Researchers closely monitor treatment toxicity, hospitalizations, dose modifications, and survival. The total planned enrollment is 587 patients, with follow-up for safety and effectiveness throughout the treatment period.

Researchers are studying the changes and characteristics of the gut microbiome during chemotherapy in patients with metastatic or irresectable colorectal cancer (CRC). The study aims to explore how the gut microbiome relates to the effects of chemotherapy, as current treatments have limited overall survival and significant side effects. Understanding the microbiome could help improve treatment selection and effectiveness for CRC patients undergoing systemic anti-tumor therapy. Participants will collect fecal samples at home before starting treatment and three months after treatment begins, coinciding with response evaluations. They will also fill out questionnaires about factors that might affect the microbiome, such as antibiotic or proton pump inhibitor use. Additionally, blood samples will be collected before treatment and three months later for storage and analysis. Treatments include any combination of chemotherapy with or without anti-VEGF or anti-EGFR therapy. During the study, researchers will monitor changes in the gut microbiome and evaluate the patients' response to chemotherapy over two years. Outcome measures include prediction of response to conventional systemic anti-tumor therapy. Participants must provide informed consent and comply with study procedures, including sample collection and questionnaires. The study focuses on improving understanding of the microbiome's role in treatment outcomes and safety in metastatic or irresectable CRC.

Researchers are evaluating treatments for men with high-risk non-metastatic prostate cancer to compare robot-assisted radical prostatectomy (RARP) and external beam radiotherapy (EBRT), which may be combined with androgen deprivation therapy (ADT). This study aims to understand which treatment better supports health-related quality of life, functional outcomes, cost-effectiveness, progression-free survival, and distant metastasis-free survival. Currently, there is no clear consensus on the optimal treatment, leading to varied use of these options across hospitals. The study examines these two common treatment methods for high-risk prostate cancer. Both RARP and EBRT (with or without ADT) have side effects that can affect patients' quality of life. By collecting detailed data on outcomes and costs, the study seeks to provide evidence to guide treatment choices and improve shared decision-making between patients and healthcare providers. Participants will be followed for at least three years after starting treatment. During this time, researchers will assess functional outcomes and health-related quality of life. These long-term measures will help determine how each treatment impacts patients over time, supporting better personalized care and informing national guidelines.

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.