East Kilbride

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.

This research investigates whether personalized medical treatment guided by a special diagnostic procedure during invasive coronary angiography can improve symptoms, wellbeing, cardiovascular risk, and clinical outcomes in patients with angina but no significant blockage in their coronary arteries. It focuses on patients with ischaemic heart disease, particularly those with angina without obstructive coronary artery disease INOCA, a condition affecting the small vessels of the heart. The trial builds on earlier pilot studies that suggested this approach could improve quality of life and symptom control by tailoring diagnosis and treatment more precisely. Participants undergo functional coronary angiography with a guidewire-based interventional diagnostic procedure IDP that measures coronary vascular function to classify patients into specific diagnosis groups, such as microvascular or vasospastic angina. Eligible patients are randomized into two groups one where IDP results are disclosed to clinicians to guide treatment, and another where IDP is performed but results are hidden, with care based on standard angiography and clinical information. Both groups receive medical therapy and lifestyle advice based on their diagnosis. The study also includes a registry for patients with obstructive disease who are not randomized. During the study, participants complete symptom questionnaires like the Seattle Angina Questionnaire to assess their angina symptoms and quality of life over at least 12 months. Researchers monitor health status, clinical outcomes, safety, and health economics, with ongoing follow-up planned for up to 10 years. Both patients and their usual care clinicians are blinded to the group allocation, but informed about the diagnosis to guide treatment. The trial aims to enroll 1500 participants across multiple centers in Europe, assessing the feasibility and impact of this stratified medicine approach.

Researchers are studying the use of magnetic resonance tumour regression grade mrTRG as a new imaging biomarker to guide treatment decisions for patients with locally advanced rectal cancer. This phase III trial is unique in the UK as it offers a watch and wait approach for patients showing a good response to preoperative treatment, potentially avoiding surgery. The trial aims to validate mrTRGs ability to identify patients who can safely defer surgery and those who may need intensified treatment, thus tailoring care based on MRI findings. Participants are randomly assigned to one of two groups. The control group receives management according to national guidelines with post-treatment MRI scans interpreted without mrTRG assessment. The intervention group has their post-treatment MRI scans evaluated by specially trained radiologists to assign an mrTRG grade. Patients with a good response mrTRG 1 & 2 are offered a watch and wait approach to avoid surgery, while those with a poor response mrTRG 3-5 have their cases reviewed by a local colorectal multidisciplinary team for further treatment planning and surveillance. Treatment decisions, including chemotherapy use, follow routine clinical practice and are documented but not dictated by the trial. Participants undergo regular monitoring for up to five years, including routine post-treatment MRI scans following the MERCURY protocol and quality of life questionnaires at registration, 3 years, and 5 years. The study assesses if surgery can be safely avoided after a good MRI response and tracks surgical outcomes, survival, quality of life, and economic impact. Additional evaluations include reproducibility of mrTRG readings, molecular and immunological markers, and circulating tumor DNA to predict relapse. This long-term follow-up aims to improve personalized treatment for rectal cancer patients.

Researchers are evaluating the use of eplerenone, a drug that blocks mineralocorticoid receptors, in patients who have had a heart attack or heart injury but do not have blocked large coronary arteries. The study focuses on patients with problems in small blood vessels in the heart, known as coronary microvascular dysfunction. The goal is to see if eplerenone can reduce heart damage and improve heart function in this group, as well as to better understand this condition using advanced tests and imaging. The trial includes a registry-based diagnostic study and a nested randomized, open-label, blinded-endpoint trial. Patients admitted with suspected heart attack undergo angiograms to assess small vessel function using a special guidewire. Those with coronary microvascular dysfunction measured by an index of microvascular resistance IMR 25 are randomly assigned to receive either eplerenone tablets, starting at 25 mg daily and increased to 50 mg after two weeks for six months, or standard care without eplerenone. Patients without microvascular dysfunction enter a registry for follow-up. Additional imaging including heart MRI and brain MRI substudies are performed. Participants will be closely monitored during hospital stays and through follow-up visits at one and six months, involving blood tests, heart MRI scans, and questionnaires assessing health status and quality of life. Long-term health outcomes such as hospitalizations and survival will be tracked via electronic records for up to 20 years. The main outcome measured is the change in heart injury biomarkers NT-proBNP over six months, alongside assessments of heart function, patient well-being, and other cardiovascular events.

Researchers are studying bronchiectasis in adults and adolescents aged 12 to under 18 who produce sputum and have experienced flare-ups. The trial aims to evaluate whether the medicine BI 1291583 can help reduce these flare-ups compared to a placebo. Participants are randomly assigned to receive either BI 1291583 or a placebo in a phase III, double-blind study. Participants take one tablet of either BI 1291583 or placebo once daily for up to 1 year and 6 months. The study includes two groups one receiving the active medication and the other receiving placebo tablets that look identical but contain no medicine. The study period lasts up to 1 year and 8 months, during which participants attend up to 10 site visits and receive about 13 phone calls. During the study, participants regularly record their bronchiectasis symptoms in a smartphone diary. Study doctors monitor participants health, note any flare-ups, and check for unwanted effects. Researchers compare the number of flare-ups between the two groups as the primary measure. Secondary measures include time to first flare-up, quality of life changes, lung function changes, and rates of severe flare-ups.

The trial investigates the role of ixazomib in patients with relapsed multiple myeloma who have previously undergone autologous stem cell transplant ASCT. It is a phase III, randomized, controlled, multi-center, open-label study aiming to assess whether adding a proteasome inhibitor to salvage ASCT conditioning improves depth of response and how consolidation and maintenance therapy influence the durability of response. The study also evaluates overall survival, progression-free survival, response rates, minimal residual disease, toxicity, and quality of life. Participants first receive re-induction therapy with 4 to 6 cycles of ixazomib, thalidomide, and dexamethasone ITD, each cycle lasting 28 days. Those achieving at least stable disease are randomly assigned to receive either conventional ASCT using melphalan alone or augmented ASCT combining melphalan with ixazomib. After ASCT, participants with minimal response or better are further randomized to either receive consolidation with 2 cycles of ITD followed by ixazomib maintenance until disease progression or no further treatment. During the study, participants undergo regular assessments including response evaluation 100 days post-ASCT, monitoring of progression-free survival for up to 120 months, and measurement of minimal residual disease at several time points. Safety and toxicity are closely monitored throughout re-induction, post-ASCT, consolidation, and maintenance phases. Quality of life questionnaires are completed at baseline, post-re-induction, post-ASCT, and during follow-up visits up to 24 months. The study plans to register 406 participants, with 284 randomized at the first stage and 248 at the second stage.