Stockton On Tees

Researchers are evaluating new treatments for men with prostate cancer that has spread to other parts of the body and still responds to hormone therapy. This Phase 3 trial compares two additional therapies with the best standard care to see if they slow cancer spread and improve survival. Participants from diverse backgrounds across multiple UK hospitals are involved, and the study is managed by University College London. The trial has two main comparisons. In Comparison S, participants receive either standard care alone or with added targeted high-dose radiotherapy (Stereotactic Ablative Body Radiotherapy or SABR) aimed at metastatic lesions. In Comparison P, participants receive standard care alone or with a radioactive drug (177Lu-PSMA-617) that targets prostate cancer cells. Standard care includes long-term hormone-reducing therapy and may include other approved medications or treatments. Treatments are given according to specific schedules: SABR is delivered in 3-5 sessions over 1-2 weeks, while 177Lu-PSMA-617 is given in up to three 6-week cycles. Participants are randomly assigned to either standard care or the new treatment with equal chance. During the study, participants undergo regular scans and tests to monitor cancer and side effects. Doctors track treatment safety and may stop treatment if side effects become serious or participants choose to stop. The main outcome measured is overall survival, with final results expected around 5 to 7 years after the first patient starts treatment. Participants' health status and response to treatment are closely observed throughout the study period.

Researchers are evaluating ziltivekimab as a treatment for people living with heart failure and inflammation. This Phase 3 study compares ziltivekimab to a placebo in participants with heart failure who have mild to preserved ejection fraction and systemic inflammation. The study aims to assess the effect of ziltivekimab on cardiovascular death, heart failure hospitalization, or urgent heart failure visits over a period of up to 4 years. Participants will receive monthly injections of either ziltivekimab or a placebo using a pre-filled syringe or a pen-injector. The study medication is administered subcutaneously once a month for up to 4 years. The trial includes up to 20 clinic visits during which participants will be monitored and assessed. During the study, participants will use a study app on their phone to record all injections and complete questionnaires. Researchers will monitor participants for key outcomes like cardiovascular events and heart failure episodes from the time of randomization until the end of the study. Safety and health status will be regularly evaluated throughout the study period, which may last up to 48 months.

Researchers are studying the immune response and safety of mRNA-1018-H5, a pandemic influenza vaccine, in adults aged 18 years and older. The trial aims to assess how well two doses of this vaccine trigger antibody production and to monitor any side effects or reactions. This is a Phase 3, randomized, observer-blind, placebo-controlled study focused on the influenza virus. Participants will receive either the mRNA-1018-H5 vaccine or a placebo, both provided as sterile liquid injections. The study involves two doses and includes detailed monitoring for immune response and side effects after vaccination. The trial compares the vaccine to a placebo to evaluate its immunogenicity and safety. During the study, individuals will undergo medical evaluations including physical exams and pregnancy testing if applicable. Researchers will measure antibody levels at Day 43 and record any local or systemic reactions up to Day 29 after injections, as well as any adverse events up to Day 205. The study tracks serious and medically-attended adverse events to ensure careful safety monitoring throughout the participation period.

Researchers are studying the safety and effects of an investigational medicine called PF-08653944 in adults who are overweight or have obesity along with type 2 diabetes. This condition involves carrying too much body weight and having high blood sugar levels. The study is a phase 3, multi-center, randomized placebo-controlled trial that aims to evaluate the medicine's ability to help with weight loss and monitor its safety. Participants will receive either the study medicine or a placebo by weekly injections under the skin in the belly area. About two-thirds of participants will get the study medicine, while one-third will receive the placebo. Participants will be trained to administer the injections themselves at home. The study will last about 21 months and includes up to 14 visits to the study site and 5 phone calls. During the study, participants will be closely monitored through visits and phone contacts. Researchers will measure changes in body weight from the start to week 64 to evaluate effectiveness. The study will also include assessments of safety and treatment effects over the entire duration. Participants need to perform finger-stick glucose monitoring as required and follow the study procedures throughout the trial.

Researchers are evaluating the effect of muvalaplin on reducing cardiovascular risk in adults with elevated lipoprotein(a) levels who either have atherosclerotic cardiovascular disease or are at risk for a heart attack or stroke. This Phase 3, randomized, double-blind, placebo-controlled study focuses on adults with high Lp(a) levels and prior or potential cardiovascular events. The study aims to assess the time to the first major adverse cardiovascular event over about 5.25 years. Participants will be randomly assigned to receive either muvalaplin or a placebo, both administered orally. The study includes individuals with Lp(a) levels of at least 175 nanomoles per liter who have had a prior cardiovascular event within 10 years or are at risk for a first event due to conditions such as coronary artery disease, carotid stenosis, peripheral artery disease, high coronary artery calcium score, reduced kidney function with diabetes, or other high-risk factors. The treatment period lasts through the study duration, with close monitoring. During the study, participants will be regularly evaluated to track the occurrence of major adverse cardiovascular events, including heart attacks and strokes. Safety assessments will monitor blood pressure, kidney function, and heart failure status among other health indicators. The primary outcome measures the time to the first major cardiovascular event from baseline up to the end of the study, which spans approximately 5.25 years.

Researchers are evaluating the use of Targeted Sentinel Node Biopsy (TSNB) in patients with breast cancer who have limited nodal disease. This study focuses on patients with biopsy-confirmed axillary nodal metastases and aims to audit surgical outcomes of TSNB against sentinel node biopsy outcomes, arm lymphoedema rates, and disease progression. The research highlights the importance of assessing nodal tumour burden and compares TSNB with other treatments like axillary lymph node dissection (ALND) and axillary radiotherapy (ART). Previous trials like AMAROS, OTOASOR, and POSNOC provide background on nodal treatment strategies and outcomes. Participants will undergo TSNB during primary surgery, where at least three lymph nodes, including a marked biopsy-proven positive node, are removed. Node marking can be done at biopsy or a separate visit using various techniques such as clips, dyes, or magnetic markers. The procedure follows a standardized approach adapted from the ATNEC trial, with either dual- or single-tracer sentinel node biopsy methods. If the marked node is not found or multiple black nodes appear, removal may stop after four nodes. The study focuses on patients with one or two macrometastases identified in the removed nodes. During the study, patients will be monitored for outcomes including the number of nodal macrometastases over 12 to 60 months, the identification rate of the marked node, and the false negative rate of the TSNB procedure. Arm lymphoedema will also be assessed up to 60 months. This audit collects data to benchmark surgical outcomes and evaluate arm morbidity and disease progression compared to existing trials, aiming to establish TSNB as a reliable staging method in this patient group.

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 conducting a national multi-center study over five years to identify factors that best predict patients at high risk for colorectal cancer or colorectal adenomas. This study aims to develop a risk prediction model that considers various risk factors beyond age, such as smoking, alcohol use, family history, obesity, and gut bacteria composition. The study will recruit 10,000 patients undergoing colonoscopy either through the Bowel Cancer Screening Programme or due to symptoms, with a further 10,000 patients from the North of England consenting to future research contact. Participants will undergo diagnostic colonoscopy and complete health questionnaires. Measurements such as height, weight, and waist circumference will be taken. Blood, stool, or saliva tests will also be collected depending on the colonoscopy indication. Results from colonoscopies and any samples taken will be compiled. Additionally, patients will complete a patient experience questionnaire or food frequency questionnaire. The study will explore the role of gut bacteria in patients with adenomas or cancer to enhance the risk prediction model. Participants will be monitored for the occurrence of colorectal neoplasia over five years. The study will collect and analyze data from questionnaires, laboratory tests, and colonoscopy findings to evaluate risk factors. Safety and patient experience will be assessed through questionnaires. The study also plans to build a large patient platform for future research opportunities, aiming to improve early detection and personalized risk assessment for colorectal cancer.

Researchers are investigating the combination of lasofoxifene and abemaciclib compared to fulvestrant and abemaciclib to treat women and men with locally advanced or metastatic estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) breast cancer that has an ESR1 mutation. This phase 3 study includes patients who have previously received treatment with ribociclib or palbociclib and aims to evaluate the effectiveness, safety, and tolerability of these treatment combinations. Participants will be randomly assigned to receive either oral lasofoxifene at 5 mg daily combined with oral abemaciclib 150 mg twice a day, or intramuscular fulvestrant 500 mg on specific days followed by monthly doses plus oral abemaciclib 150 mg twice daily. The treatment schedules are designed to compare how well these combinations work in managing the cancer. During the study, participants will be closely monitored for progression-free survival over approximately three years. Researchers will assess the cancer's response to treatment, track any side effects, and evaluate safety and tolerability. Regular evaluations and follow-ups will ensure comprehensive data collection to understand the impact of these therapies on advanced breast cancer.

Researchers are evaluating the optimal duration of antibiotic treatment for adults with complicated intra-abdominal infections (cIAI). This Phase 3 trial aims to compare a fixed extended duration of 28 days of antibiotics to the current standard care durations, which typically range from 7 to 18 days. The study will assess clinical outcomes, quality of life, and cost effectiveness over a 180-day follow-up period to determine which approach may better reduce treatment failure and improve patient care while considering antimicrobial resistance concerns. Participants will be randomly assigned to one of two groups: the standard care group, where antibiotic type and duration are determined by their clinician, or the fixed extended-duration group, which receives antibiotics for a set 28-day period. The study includes a total of 1166 adult patients recruited from intensive care units and hospital wards across approximately 30 NHS trust hospitals. The treatment period is followed by monitoring up to 180 days after randomization. During the study, patients or their personal consultees will complete quality of life questionnaires at baseline and at 30, 60, and 180 days post-randomization. They will also provide information about antibiotic use and healthcare resource utilization. Researchers will collect hospital records on admissions, relapses, and further infections. The main outcome measured is treatment failure within 180 days of randomization, with safety and effectiveness assessed throughout the follow-up period.