South Shields

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 establishing the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer (IRONMAN), a study enrolling at least 5,000 men with advanced prostate cancer, including metastatic hormone-sensitive prostate cancer (mHSPC) and metastatic castration-resistant prostate cancer (M0/M1 CRPC). This international cohort will collect data from patients across various countries including Australia, Barbados, Brazil, Canada, and others to better understand differences in care and treatment across academic and community settings worldwide. Participants will receive standard care treatments for metastatic prostate cancer as determined by local practices. The study will collect detailed data at enrollment and during follow-up for a minimum of five years. Blood samples and, when feasible, tumor tissue will be collected at enrollment, at treatment changes, and at one-year follow-up to help identify molecular markers related to treatment response and resistance. During participation, patients will complete patient-reported outcome measures (PROMs) at enrollment and every three months. Physicians will provide questionnaires at enrollment, treatment changes, one-year follow-up, and treatment discontinuation. Researchers will track overall survival, adverse events, comorbidities, treatment changes, and patient quality of life to identify optimal treatment sequences and outcomes for men with advanced prostate cancer.

Researchers are evaluating a range of treatments to improve outcomes for adults admitted to intensive care units (ICUs) with severe community-acquired pneumonia (CAP), including cases caused by influenza and COVID-19. This Phase 3 adaptive platform trial, REMAP-CAP, is designed to test multiple treatment strategies simultaneously and adapt over time, allowing new treatments to be added as questions are answered. The trial also serves as a platform to quickly evaluate treatments during respiratory pandemics, such as COVID-19, through a sub-study called REMAP-COVID in the United States. Participants receive various interventions including antibiotics like ceftriaxone, moxifloxacin, or piperacillin-tazobactam, as well as macrolide therapies given for different durations. Other treatments assessed include corticosteroids such as hydrocortisone and dexamethasone, antiviral agents like oseltamivir and remdesivir, immune modulators including tocilizumab and baricitinib, and supportive care strategies such as mechanical ventilation methods. Dosing and duration vary for each treatment, with some interventions now closed. Treatments are administered according to local guidelines and clinical decisions, with some requiring intravenous or enteral routes. Participants are closely monitored with assessments focusing on survival and organ support status in the ICU up to 90 days after enrollment. The main outcomes measured include all-cause mortality by day 90 and the number of days alive without needing organ support in the ICU by day 21. The study collects data continuously to adapt treatment assignments for new participants, aiming to identify the most effective therapies. Follow-up and safety monitoring continue throughout hospitalization and up to 90 days after admission.

Researchers are investigating treatments for patients with localized renal cell carcinoma (RCC) who have undergone nephrectomy, focusing on those at high or intermediate risk of the cancer returning. The study evaluates whether durvalumab alone or combined with tremelimumab can improve disease-free survival or overall survival compared to the current standard of care, which is active monitoring. This phase III multi-arm, multi-stage randomized controlled trial includes patients with specific risk scores, and recruitment of intermediate risk patients will be limited based on time and accrual targets. Participants will be randomly assigned to receive either durvalumab alone, the combination of durvalumab and tremelimumab, or active monitoring. The drugs are given via controlled infusion through a pump into a vein. The trial includes a screening phase and treatment period, with careful monitoring of patients' disease status and side effects throughout the study. During the study, participants will undergo clinical and radiological assessments, including post-operative scans and laboratory tests like blood counts and ECGs. Researchers will track disease-free survival and overall survival over several years, including specific time points up to 20.5 years for some comparisons. Participants will also provide tissue and blood samples for future research. Safety and treatment effects will be closely monitored to understand how the therapies impact long-term outcomes.

Chronic obstructive pulmonary disease (COPD) is a common lung condition affecting about 10% of adults worldwide, with a prevalence of 4.5% in those aged 40 years and older in the UK. Exacerbations, or sudden worsening episodes often triggered by infections, can lead to hospital admissions and carry risks of increased illness and death. This trial focuses on the high-risk 90-day period after hospital discharge, during which patients have a 43% chance of readmission and 12% risk of mortality. The study aims to test whether a supported rescue pack management plan can reduce readmissions by 20%. This is a Phase 3, open-label, multicenter randomized controlled trial involving 1400 patients across 30 NHS trusts.

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.