South Shields

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 establishing the International Registry to Improve Outcomes in Men with Advanced Prostate Cancer IRONMAN as a prospective, global group of at least 5,000 men with advanced prostate cancer, including those with metastatic hormone-sensitive prostate cancer mHSPC and metastatic castration-resistant prostate cancer M0M1 CRPC. This study aims to better understand variations in care and treatment across different countries and medical settings by collecting detailed patient data over time. Participants will receive standard care drugs routinely used for metastatic prostate cancer based on local practices. Data collection begins at enrollment and continues for at least five years. Blood samples and tumor tissue, when possible, will be collected at enrollment, treatment changes, and follow-ups to study molecular markers linked to treatment response and resistance. Patient-reported outcome measures PROMs will be gathered every three months, and physicians will provide treatment and follow-up information regularly. During the study, participants will provide health and treatment information through questionnaires, with regular monitoring of survival, adverse events, and comorbidities. Blood samples will support future research to identify biomarkers. The main outcome is observing practice patterns over five years to help improve understanding of treatment sequences that optimize survival and quality of life for men with advanced prostate cancer.

Researchers are evaluating treatments for community-acquired pneumonia CAP, especially in patients admitted to intensive care units ICUs. This trial also adapts to study treatments for respiratory pandemics like COVID-19. The goal is to determine which treatment strategies improve outcomes for patients with severe pneumonia, using a flexible, ongoing approach that can test multiple therapies simultaneously and update as new information becomes available. Participants receive different treatment strategies based on random assignment to study groups. Treatments include various antibiotics, steroids, antivirals, immune modulators, anticoagulation methods, and ventilation strategies. Some treatment options have been closed to recruitment, reflecting the trials adaptive nature. The trial includes several domains targeting specific infections such as influenza and COVID-19, with dosing and duration guided by clinical practice and local guidelines. During the study, participants are monitored closely with assessments including survival up to 90 days, days alive without organ support in ICU, ICU and hospital length of stay, ventilator-free days, organ failure-free days, and quality of life up to 6 months. Researchers collect detailed data on patient outcomes, organ support needs, and hospital discharge status. The study runs until February 2028, with ongoing evaluation to improve pneumonia treatment strategies in ICU settings and during respiratory pandemics.

Researchers are evaluating treatment options for patients with localized renal cell carcinoma RCC who have undergone nephrectomy and are at intermediate or high risk of disease recurrence. This phase III randomized controlled platform trial, called RAMPART, aims to assess whether durvalumab alone or combined with tremelimumab can improve disease-free survival or overall survival compared to the current standard care of active monitoring. The study includes patients with Leibovich scores between 3 and 11, focusing on those at intermediate and high risk of relapse after surgery. Participants will be randomly assigned to one of three groups active monitoring for one year, durvalumab monotherapy given as 1500 mg infusions every four weeks for up to 13 cycles, or a combination of durvalumab same dosing with tremelimumab administered twice during the first month. The trial monitors patients over several years to compare outcomes between these groups, including disease-free survival, overall survival, and metastasis-free survival. During the study, participants will undergo clinical and radiological assessments, including post-operative CT scans before randomization and routine follow-ups during treatment and observation. Researchers will collect tissue samples and blood for future research. Safety and health will be closely monitored through laboratory tests, ECGs, and performance status evaluations. The study may last up to 20 years for the longest follow-up on overall survival and other outcomes.

Chronic obstructive pulmonary disease COPD is a common lung condition affecting many adults worldwide, with exacerbations leading to worsening health and hospital admissions. This trial focuses on patients recently discharged after a hospital stay for a COPD exacerbation, aiming to reduce the risk of readmission and improve outcomes during the critical 90-day high-risk period after discharge. The study is a phase 3, multicenter randomized controlled trial addressing an important healthcare challenge and potential cost savings for the NHS. The trial compares a supported rescue pack management plan to standard care. Participants in the supported rescue pack group receive a 5-day rescue pack of prednisolone and antibiotics, a written self-management plan based on the Asthma-Lung UK plan, and twice-weekly automated phone or text symptom assessments for 90 days. Those in the standard care group do not receive rescue packs on discharge but may access them through community care. The trial will monitor the use of rescue packs and support provided during the 90-day period. Participants will be involved in regular symptom monitoring through automated calls or texts and follow-up assessments. Researchers will measure time to first hospital readmission within 90 days as the primary outcome, along with secondary outcomes including readmission frequency, days alive and out of hospital, corticosteroid and antibiotic use, healthcare contacts, quality of life, and cost-effectiveness. Safety monitoring will include adverse events and antimicrobial resistance over an average of 4 years, with participant involvement lasting up to one year for some assessments.

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.