Stockton On Tees

Researchers are evaluating two new treatments compared to the best standard care for men with prostate cancer that has spread to other parts of the body and still responds to hormone therapy. This phase 3 trial includes multiple hospitals across the UK and is led by University College London. The study aims to see if adding targeted radiotherapy or a radioactive drug can slow cancer spread and improve survival. Participants are assigned by computer to one of several groups. One group receives standard care, which includes androgen deprivation therapy ADT plus other hormone therapies, possible chemotherapy with docetaxel, and local radiotherapy. Another group receives standard care plus targeted high-dose radiotherapy SABR to metastatic sites. A third group receives standard care plus a radioactive therapy called 177Lu-PSMA-617, given in cycles with two doses per cycle. Treatments continue unless side effects are severe or participants choose to stop. During the study, participants will have scans and tests to monitor their cancer and side effects. Doctors will check safety and treatment adherence over time. Researchers will measure overall survival, failure-free survival, progression-free survival, prostate cancer-specific survival, and quality of life up to 10 years from randomization. Safety will be closely monitored, and participants health will be followed during and after treatment.

This trial investigates adults aged 45 to 80 with elevated Lipoproteina Lpa levels, who either have existing cardiovascular disease or are at risk for a first cardiovascular event. The study aims to evaluate how lepodisiran, compared to a placebo, affects the amount and type of plaque in the coronary arteries using Coronary Computed Tomography Angiography CCTA. Lipoproteina is a protein carrying cholesterol and is linked to higher heart disease risk. Participants are randomly assigned to receive either lepodisiran or a placebo through subcutaneous injections. The study lasts about 120 weeks, with primary evaluation of changes in noncalcified plaque volume at baseline and at week 104. Secondary measures include changes in fat attenuation index scores, Lpa levels over time, participant feedback on drug administration, and pharmacokinetic analysis. Throughout the study, participants will undergo imaging assessments, blood tests to monitor Lpa levels, and questionnaires regarding treatment experience. The main outcome is the percent change in noncalcified plaque volume in heart vessels. The study includes safety monitoring and continues follow-up to assess effects comprehensively over the study period.

Researchers are evaluating the effect of muvalaplin in lowering cardiovascular risks among adults with elevated lipoproteina who either have atherosclerotic cardiovascular disease or are at risk of a first heart attack or stroke. This phase 3, randomized, double-blind study aims to investigate whether muvalaplin can reduce major adverse cardiovascular events compared to placebo in this high-risk population. Participants are randomly assigned to receive either muvalaplin or a placebo, both given orally. The study is designed with parallel groups and will last about 5.25 years, during which the occurrence of cardiovascular events and changes in lipoproteina levels will be closely monitored. Throughout the study, participants will undergo regular assessments including measurement of lipoproteina levels, monitoring of cardiovascular events such as heart attacks or strokes, and evaluation of healthcare resource use. The primary outcome is the time to first major adverse cardiac event, tracked from baseline until the study ends. Safety and pharmacokinetics of muvalaplin will also be evaluated during the trial period.

Researchers are evaluating the use of Targeted Sentinel Node Biopsy TSNB in patients with breast cancer who have limited nodal disease and are undergoing primary surgery. The study focuses on patients with T1 or T2 tumors and biopsy-confirmed nodal metastases with up to two abnormal nodes on axillary ultrasound. The goal is to audit surgical outcomes of TSNB and compare them with outcomes from sentinel node biopsy and targeted axillary dissection after chemotherapy, assessing arm lymphoedema and disease progression over time. The intervention involves performing TSNB using either a dual- or single-tracer technique in line with protocols from the ongoing ATNEC trial. The marked biopsy-positive node and at least three nodes are removed during surgery. Node marking techniques may include clips, black dye, magnetic seeds, or reflectors, with the timing of marking either at biopsy or a separate visit. Axillary treatment after TSNB is determined by local multidisciplinary teams based on findings. Participants will be monitored for up to 60 months, with regular assessments including histology to identify nodal macrometastases, identification rates of the marked node, false negative rates of TSNB, and arm lymphoedema. Secondary outcomes include rates of axillary, regional, and local recurrence, disease-free survival, and overall survival. This long-term follow-up will help benchmark TSNB outcomes against previous trials and provide data on surgical morbidity and disease control.

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.

Researchers are evaluating a specially designed balance training program called Sport4Steadiness S4S aimed at people with Chronic Obstructive Pulmonary Disease COPD. The study focuses on whether this program is acceptable to participants and if the study methods, including recruitment and outcome collection, are practical and workable for this group. The trial uses a randomized design to compare usual care with the new balance training approach after pulmonary rehabilitation. Participants in the study are randomly assigned to one of two groups. One group continues their usual home-based exercise program provided as part of pulmonary rehabilitation, which serves as the control or usual care. The other group participates in the Sport4Steadiness program, which adapts elements from various sports and activities to improve balance while also promoting social interaction. The S4S sessions are held twice a week for six weeks, totaling 12 sessions, each lasting two hours with one hour dedicated to activity and one hour to socialization. During the trial, participants undergo assessments at the end of recruitment, after randomization, and approximately 12 weeks following the baseline assessment. Researchers monitor the feasibility of delivering the S4S program and the study procedures themselves. The study evaluates how well participants adhere to the program and collects data related to balance and falls. The total duration of participation includes these assessments and the intervention period, allowing for a thorough evaluation of the programs feasibility and acceptability.

Researchers are studying colorectal cancer and colorectal adenomas to identify factors that best predict patients at high risk and to develop a risk prediction model. This observational study is national and multi-centre, focusing on patients undergoing colonoscopy either as part of the Bowel Cancer Screening Programme or due to symptoms. It addresses the limitation that current screening mainly considers age and aims to include other risk factors like smoking, alcohol use, family history, obesity, and gut bacteria composition. Participants will be divided into two groups one group of 10,000 patients referred for colonoscopy will provide detailed health and lifestyle information, including blood, stool, and saliva samples for various tests. Another group of 10,000 patients from the North of England will consent to be contacted for future research studies, providing some health information for this purpose. The study collects data on colonoscopy results, lifestyle factors, and patient experiences through questionnaires. During the study, patients will undergo measurements such as height, weight, and waist circumference, and complete health and food frequency questionnaires. Researchers will analyze colonoscopy findings, stool microbiome patterns, and biological samples to develop a risk prediction model for colorectal neoplasia. The study also aims to establish a platform of patients willing to participate in future research, with all results and patient consents tracked over a five-year period.

Researchers are evaluating the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib for treating pre- and postmenopausal women and men with locally advanced or metastatic estrogen receptor positive ERhuman epidermal growth factor 2 negative HER2- breast cancer who have an ESR1 mutation and have previously been treated with ribociclib or palbociclib. The study aims to compare the effectiveness, safety, and tolerability of these two treatment combinations. Participants are randomly assigned to one of two groups one receives 5 mg daily oral lasofoxifene plus oral abemaciclib 150 mg twice a day the other receives fulvestrant 500 mg via intramuscular injections on Days 1, 15, and 29 and then monthly thereafter, combined with oral abemaciclib 150 mg twice a day. This open-label study assesses these treatments over approximately three years. During the trial, participants will be monitored through regular assessments including tumor measurements, survival tracking, quality of life questionnaires, and evaluation of adverse events. Researchers will measure progression-free survival as the primary outcome and also track response rates, overall survival, treatment duration, and time to chemotherapy. Brain metastases patients meeting specific criteria are allowed, and safety is closely observed throughout the study period which may last up to about three years.

Researchers are investigating a new way to treat patients with malignant pleural effusion, a condition where fluid builds up around the lungs causing breathlessness. The study aims to see if talc pleurodesis, a procedure to stop fluid buildup that usually requires hospital stay, can be safely done on an outpatient basis to improve quality of life. The study also collects patient feedback on the acceptability of this approach. Participants will have a chest drain inserted on the first day to remove fluid using a standard underwater seal bottle. The drain is clamped and opened repeatedly to remove fluid throughout the day before being connected to an ambulatory bag for the patient to go home. On the second day, fluid output is assessed, and if appropriate, talc slurry with lidocaine is instilled to prevent fluid return. The drain remains connected to the ambulatory bag as patients return home. On the third day, further fluid drainage and chest x-rays determine if the drain can be removed and the treatment completed. During the study, patients complete brief questionnaires about breathlessness, chest pain, and satisfaction with the procedure at multiple times on days 1 to 3 and again at day 30. Researchers will monitor the success of delivering the ambulatory talc pleurodesis protocol, patient satisfaction, and safety through chest x-rays and follow-up. The entire treatment and observation span about five days with ongoing follow-up after completion.

Researchers are evaluating whether using MRI imaging for staging sigmoid colon adenocarcinoma can change treatment plans by detecting more high-risk tumors compared to standard CT imaging. This randomized phase II multicenter trial aims to improve radical treatment decisions and provide better prognostic information to patients. The study involves patients eligible for curative treatment whose MRI can be reviewed before surgery without a prior treatment decision. Participants are assigned randomly to one of three groups standard preoperative CT imaging with multidisciplinary team discussion, standard CT plus an additional preoperative MRI scan with team discussion, or observation only. The MRI provides supplementary diagnostic information that may alter treatment strategies based on local protocols. During the study, patients are followed up at 1 and 3 years with quality of life questionnaires. Researchers assess differences in cancer staging between CT and MRI, treatment changes, recurrence rates, disease-free survival, surgery quality, pathology outcomes, morbidity and mortality, and permanent stoma rates. The total follow-up extends up to 5 years after treatment, with outcomes measured at multiple time points to understand the impact of MRI staging on patient care.