Llanelli

Researchers are evaluating whether skipping additional axillary treatment for patients with early-stage breast cancer who had cancer in their lymph nodes before chemotherapy but show no remaining cancer in those nodes after treatment is as effective as the standard approach. This study focuses on disease-free survival and reducing the risk of lymphoedema five years after treatment. It is a randomized, open, multicenter trial including patients with specific breast cancer stages and confirmed nodal metastases. Participants will all receive standard therapies including HER2-targeted treatment, endocrine therapy, and radiotherapy to the breast or chest wall if needed. They will be randomly assigned to one of two groups one group will not get further axillary treatment such as lymph node removal or radiotherapy, while the other group will receive these axillary treatments according to local guidelines. Follow-up visits will occur annually for at least five years. During the study, participants will undergo assessments to monitor disease-free survival and self-reported lymphoedema using specific questionnaires. Additional evaluations include arm function, quality of life, recurrence rates, survival, and cost-effectiveness analyses. The total study duration is planned for 120 months, including setup, recruitment, follow-up, analysis, and reporting.

Diabetic Retinopathy DR is a common complication of diabetes that damages the small blood vessels in the retina, potentially leading to vision loss. Researchers are studying the metabolic and lipid profiles in people with type 2 diabetes at different stages of DR to better understand the diseases underlying mechanisms. This observational study aims to identify chemicals in the blood and the role of gut bacteria that may influence retinal damage and diabetic eye disease progression. Participants will provide blood and urine samples for detailed lipidomic and metabolomic analyses, while researchers will review medical records, previous eye photographs, and specialized retinal scans to classify the severity of DR. The study groups include patients at various stages of diabetic eye disease, ranging from no retinopathy to proliferative DR and diabetic macular edema DMO without prior treatment. Sample collection is coordinated with routine clinic visits to minimize participant burden. During the study, participants data and biological samples will be securely collected and anonymized. Researchers will analyze blood plasma and urine metabolites over several years to explore potential biomarkers and mechanisms related to DR severity. The primary outcome is the analysis of serum lipid profiles associated with DR, supported by secondary analyses of metabolic pathways and microbiome interactions. The study is planned to start recruiting in early 2025, with ongoing sample analysis continuing until 2030.

This research is focused on people with type 1 diabetes who also have symptoms of heart failure, a condition that can cause breathlessness, tiredness, and swelling. The study aims to find out if sotagliflozin, a tablet medication, can improve quality of life and heart failure symptoms for these individuals. While sotagliflozin has shown benefits in people with type 2 diabetes and heart failure, its effects on those with type 1 diabetes are not yet known. Participants will be randomly assigned to receive either sotagliflozin tablets or placebo tablets, which look identical but contain no active medicine. They will take one tablet daily for 16 weeks. This is a double-blind trial, meaning neither the researchers nor participants will know which treatment is being taken until the study ends. The trial will last about 6 months per participant, with the entire study expected to run for about 26 months. During the study, participants will have their heart failure symptoms and quality of life assessed using questionnaires like the Kansas City Cardiomyopathy Questionnaire KCCQ. Other evaluations include walking tests, blood tests for heart and diabetes markers, and monitoring for safety concerns like low blood sugar or diabetic ketoacidosis. The study will measure changes in these outcomes from the start to week 16, with ongoing safety follow-up until week 20.

Researchers are studying patients with newly diagnosed stage I, II, and III colorectal cancer CRC to understand how circulating tumor DNA ctDNA in the blood can predict disease relapse. The study evaluates whether using ctDNA to guide adjuvant chemotherapy decisions after surgery is as effective as standard chemotherapy, aiming to reduce unnecessary treatments and side effects. This multi-center, prospective research includes both observational and randomized components to better manage early-stage CRC. The study has two parts Part B focuses on collecting tumor tissue, serial blood samples, and clinical data to detect minimal residual disease MRD using ctDNA after curative surgery. Part C is a randomized trial comparing ctDNA-guided adjuvant chemotherapy versus standard care in patients with high-risk stage II or III CRC. Patients are randomized post-surgery to either standard chemotherapy or a ctDNA-guided approach where those testing negative for ctDNA may receive less chemotherapy. Participants will undergo regular blood sampling and clinical assessments to monitor ctDNA levels and disease status. Researchers will measure outcomes such as 3-year disease-free survival and the relationship between ctDNA detection and treatment response over several years. The study includes follow-up periods of 4 to 8 years to evaluate long-term outcomes and safety. Participants need to consent, adhere to follow-up schedules, and be suitable for chemotherapy if randomized to Part C.