Harrogate

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 conducting a multi-centre observational study to better understand giant cell arteritis GCA and polymyalgia rheumatica PMR, conditions mainly affecting people over 50 years old. The study aims to identify genetic factors that influence susceptibility to these diseases to provide new insights into how they develop. It includes both retrospective participants with confirmed diagnoses and prospective participants suspected of having these conditions, with some patients also enrolled in a registry monitoring tocilizumab treatment for relapsing or refractory GCA. The study collects detailed clinical, imaging, and molecular data, including genetic and proteomic analyses, from participants to characterize disease subtypes and impacts. Researchers also assess quality of life through patient-reported outcomes and track long-term prognosis by linking to health records. The study explores environmental factors and co-existing conditions to improve diagnosis, prognosis, and monitoring of disease activity, especially for patients receiving synthetic or biological disease-modifying anti-rheumatic drugs. Participants provide information during baseline assessments, including blood and urine samples for analysis, and complete questionnaires about their symptoms and quality of life. Follow-up occurs through health record review over an average of one year to evaluate diagnosis and disease outcomes. The primary measure is genetic susceptibility, with secondary outcomes focusing on disease characteristics, life impact, diagnosis, and disease activity. The study is sponsored by the University of Leeds and started in 2005, continuing through 2028.

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.

Rapid Diagnostic Centres RDCs are designed to quickly diagnose patients who show common symptoms that might be related to cancer, such as weight loss, fatigue, cough, or a general practitioners suspicion. This observational study aims to develop new blood or non-blood tests that help doctors identify which patients have cancer and which are at higher risk, so they can be monitored or directed to appropriate screening programs. The study focuses on improving diagnosis and risk assessment in patients referred to RDCs, many of whom may not have cancer but could be at risk due to inherited or environmental factors. The study collects breath, blood, and saliva samples from up to 1000 patients attending RDCs to develop tests that can detect cancer or assess cancer risk through polygenic risk scores. Samples are taken at the first appointment and follow-up visits if necessary. Patients provide consent and are assigned a unique Study ID to keep their information confidential. Clinical data, patient health questionnaires, and, for some, anonymized scans from medical records are also collected to support the development of diagnostic tools. Participants will provide samples and complete health surveys at their visits, with samples shipped to labs for analysis. The study will follow patients for 12 months after joining to confirm diagnoses and observe outcomes. Researchers will analyze clinical, genetic, imaging, and symptom data to develop models that distinguish between cancer and non-cancer cases. Patient data and samples will be stored for ten years to support future research and improved diagnostic methods.

Researchers are evaluating the real-world use of nemolizumab for treating moderate-to-severe atopic dermatitis AD in adolescents and adults. This observational study aims to assess the treatments effectiveness through physician evaluations and patient-reported outcomes over six months, providing insight into how the medication performs in everyday clinical practice. Participants receiving nemolizumab as part of their routine care will be observed for about 12 months. Treatment decisions are made by the participants physician before joining the study, with no extra visits or tests beyond usual medical care. A sub-study in Germany and the UK involves daily remote reporting of symptoms such as peak and average itch, sleep disturbance, and pain for the first two weeks. During the study, participants will have regular medical visits as determined by their doctors, with data collected from routine assessments and patient questionnaires. Researchers will measure outcomes like the Investigator Global Assessment and Peak Pruritus Numerical Rating Scale at six months, along with other severity and symptom scores up to 12 months. No additional procedures outside standard care are required, allowing for natural monitoring of treatment effects and safety.

Researchers are studying whether adding navtemadlin to ruxolitinib treatment can provide more benefit than ruxolitinib alone for adults with Myelofibrosis who have not responded well to ruxolitinib by itself. This Phase 3 trial includes patients who are new to JAK inhibitor treatment and have a confirmed diagnosis of primary or post-polycythemia vera or post-essential thrombocythemia Myelofibrosis. The study aims to assess improvements in spleen size and symptom reduction over 24 weeks, as well as long-term outcomes like disease progression and overall survival. Participants first receive ruxolitinib alone during a run-in period to identify those with suboptimal response. Those qualifying are randomly assigned in a 21 ratio to receive either navtemadlin or a placebo as an add-on to their ongoing ruxolitinib. Navtemadlin or placebo is taken orally once daily for 7 days followed by 21 days off in 28-day cycles, while ruxolitinib is taken twice daily continuously. The study is double-blinded so neither participants nor researchers know which add-on treatment is given. During the trial, participants will undergo evaluations including spleen volume measurements and symptom assessments at 24 weeks. They will be monitored for disease progression and survival for up to 8 years. The study includes regular check-ups to track side effects, treatment adherence, and overall health status. These detailed assessments help researchers understand the potential benefits and safety of adding navtemadlin for patients with Myelofibrosis.

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.