Llanelli

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.

Diabetic retinopathy (DR) is a complication of diabetes that damages the small blood vessels in the retina, leading to vision loss. This research investigates the metabolic and lipid changes in the blood of people with type 2 diabetes who have different stages of diabetic eye disease. The study also explores how gut bacteria might influence eye disease through chemicals circulating in the blood, aiming to better understand the disease process and identify potential targets to prevent vision deterioration. Participants will provide blood and urine samples, which will be analyzed using specialized techniques to identify specific molecules related to lipid and metabolite profiles. Medical records, past eye photographs, and specialist eye scans will be reviewed to classify the severity of diabetic retinopathy. The study includes people with varying levels of diabetic eye disease, ranging from no retinopathy to diabetic macular edema, and excludes those who have had certain eye treatments or genetic lipid disorders. Participants will be recruited through routine clinic visits and medical records review. Data collected will include demographic and medical history, current diabetes treatments, and detailed eye examination results. The primary outcome is a detailed analysis of blood lipids over five years to identify changes associated with diabetic retinopathy severity. The study will monitor participants for up to five years, with sample analysis continuing through 2030, ensuring long-term evaluation of metabolic markers and safety.

People with type 1 diabetes can develop heart failure, which causes symptoms like breathlessness, tiredness, and ankle swelling, reducing quality of life and leading to hospital admissions or serious outcomes. This trial is investigating whether the tablet sotagliflozin can improve quality of life for people with type 1 diabetes and heart failure. Previous studies showed benefits of sotagliflozin in type 2 diabetes patients with heart failure, but its effects on type 1 diabetes patients with heart failure are unknown. Participants will be randomly assigned to receive either sotagliflozin tablets or placebo tablets once daily for 4 months, and neither the participants nor the medical team will know who receives which treatment until the trial ends. The trial plans to enroll 320 people with type 1 diabetes and heart failure symptoms at multiple UK sites. The total participation time is approximately 6 months, with the entire trial expected to last 26 months. During the study, participants will use continuous glucose monitors and be regularly assessed for heart failure symptoms and quality of life using the Kansas City Cardiomyopathy Questionnaire. Researchers will monitor changes in questionnaire scores from baseline to week 16 as the primary outcome. Safety and tolerability of sotagliflozin will also be evaluated throughout the trial, with ongoing monitoring for any adverse effects or changes in health status.

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.