Crewe

Researchers are evaluating whether avoiding further axillary treatment after neoadjuvant chemotherapy (NACT) is as effective as standard axillary treatment for patients with early stage breast cancer who initially had cancer in the lymph nodes confirmed by needle biopsy but show no residual cancer in the lymph nodes after NACT. The study aims to determine if skipping axillary lymph node dissection (ALND) or axillary radiotherapy (ART) affects disease free survival (DFS) and whether it reduces the risk of lymphoedema five years after treatment. This phase 3, open-label, randomized trial includes patients with T1-3N1M0 breast cancer and confirmed nodal metastases who have undergone sentinel node biopsy removing at least three lymph nodes post-NACT.

Researchers are evaluating two surgical approaches for patients with low risk differentiated thyroid cancer in this multi-center, randomized, phase III study. The study aims to determine if hemithyroidectomy, which removes part of the thyroid, is an acceptable and cost-effective alternative to total thyroidectomy, which removes the entire thyroid. Patients are identified through oncology multidisciplinary team meetings and divided into two groups based on their treatment history and diagnosis method. Patients in Group 1 have already had a hemithyroidectomy for thyroid problems and are then diagnosed with low risk differentiated thyroid cancer. They will be randomized to either surveillance only or a second surgery to remove the rest of the thyroid gland (two-stage total thyroidectomy). Group 2 patients are diagnosed by cytology with low risk cancer and have not yet had surgery; they will be randomized to either hemithyroidectomy or a single-stage total thyroidectomy. The study plans to recruit 456 patients who will be followed after surgery and then every 12 months for 6 years. During the study, participants will undergo regular assessments to monitor for any signs or symptoms of cancer recurrence, with a primary outcome measure of the 3-year recurrence rate after surgery. Follow-up visits will include clinical evaluations to check for cancer return or progression. Researchers will also observe overall patient outcomes and safety throughout the 6-year follow-up period.

This research aims to assess whether adding MRI imaging to the standard CT imaging for patients with suspected or confirmed sigmoid colon adenocarcinoma influences treatment decisions. The study compares standard preoperative CT and multidisciplinary team discussions against adding MRI scans to see if MRI identifies more high-risk tumors, potentially changing treatment plans and prognosis information. Participants are randomly assigned to either the control group receiving standard care with CT imaging or the intervention group receiving an additional MRI scan before surgery. Both groups undergo multidisciplinary team reviews based on their imaging results. The intervention involves extra radiological and pathological assessments and reporting that might affect treatment choices following local protocols. Participants are followed up at 1 and 3 years after recruitment, including quality of life questionnaires. The study measures differences in cancer staging on CT versus MRI and how these differences impact treatment strategies. The total follow-up duration extends up to three years after the last participant is recruited, ensuring long-term observation of outcomes and treatment effects.

Researchers are evaluating the effects of two different default dialysate sodium concentrations, 137 mmol/l and 140 mmol/l, on major cardiovascular events and death in adults receiving maintenance haemodialysis. This pragmatic, cluster-randomised, open-label study takes place in real-world dialysis sites and aims to compare the outcomes associated with these sodium levels over an extended period. The study focuses on patients with end-stage kidney disease undergoing regular haemodialysis treatment. Dialysis sites are randomly assigned to use either a default dialysate sodium concentration of 137 mmol/l or 140 mmol/l for at least 90% of dialysis sessions at that site. All other care practices continue as usual based on local standards. The study plans to recruit sites over 5 to 7 years, with individual follow-up lasting roughly 2 to 5 years. Site participation requires consent, while individual patient consent may be waived or offered an opt-out option. Participants will be monitored for major cardiovascular events and death, with the primary outcome measuring the time until the first such event occurs. Data collection methods are implemented across participating dialysis units, focusing only on in-center or satellite dialysis patients where applicable. The study's duration depends on the occurrence of endpoints, with an average follow-up of about 5 years anticipated per participant.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

Researchers are investigating colorectal cancer (CRC) patients with newly diagnosed stage I, II, and III cancers to evaluate whether mutations in circulating tumor DNA (ctDNA) can predict disease relapse earlier than current methods. This study includes two parts: Part B focuses on analyzing tumor tissue, serial blood samples, and clinical data to detect minimal residual disease (MRD) and predict relapse, while Part C is a randomized study comparing ctDNA-guided adjuvant chemotherapy to standard care in high-risk stage II or III CRC patients post-surgery. In Part B, the study collects serial blood samples from patients who have undergone potentially curative surgery to detect and quantify ctDNA, aiming to identify MRD and predict relapse. Part C randomizes patients after surgery into two groups: one receiving standard adjuvant chemotherapy and the other receiving ctDNA-guided chemotherapy, where those testing ctDNA negative may have chemotherapy reduced. The goal is to assess if ctDNA-guided treatment can safely reduce chemotherapy use without compromising disease-free survival. Participants will undergo tumor tissue collection, blood sampling at multiple time points, and clinical assessments over several years. Researchers will monitor ctDNA levels and clinical outcomes, measuring disease-free survival up to 3 to 6 years. Safety and treatment effects will be evaluated, with follow-up visits to track relapse and treatment response. Total participation includes long-term monitoring for relapse prediction and chemotherapy guidance.

Idiopathic pulmonary fibrosis (IPF) is a progressive lung disease that causes scarring, leading to coughing and breathlessness. Many people with IPF also have reflux disease, where stomach acid may enter the lungs and cause damage. This research is evaluating whether using proton pump inhibitors (PPIs), medicines that reduce stomach acid like lansoprazole, can slow the progression of IPF. The study is a phase 3 clinical trial involving 298 IPF patients from about 37 UK hospitals to determine if treating with PPIs affects IPF outcomes and cough, reflux, and sleep symptoms. Participants will be randomly assigned to take either lansoprazole 30 mg capsules or matching placebo capsules twice daily, about 12 hours apart, for 12 months. They will be asked to start weekly home breathing tests using equipment provided, and some with a cough will use a device to count coughs over 24 hours. Questionnaires on cough, breathlessness, sleep, and general health will be completed. A sub-study involves additional cough and sleep monitoring sessions. Participants may reduce the dose if side effects occur. Throughout the study, participants will complete home spirometry assessments weekly, provide blood samples for safety checks at set intervals, and answer questionnaires at 3, 6, 9, and 12 months. Visits may be remote or in person. Researchers will monitor medication adherence, medical history changes, and side effects. The main outcome measured is the change in lung function, specifically forced vital capacity, 12 months after randomization. Additional blood samples may be collected for future research with consent.