Burnley

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 collecting real-world data on patients undergoing rotator cuff repair using the REGENETEN Bioinductive Implant System. This prospective, single-arm, multicenter registry involves up to 50 centers across the United Kingdom, Europe, and Australia, aiming to enroll up to 400 patients. The study focuses on evaluating clinical and health economic outcomes after surgery for rotator cuff injuries. Participants receive arthroscopic rotator cuff repair surgery augmented with the REGENETEN Bioinductive Implant, a device designed to manage and protect tendon injuries without substantial tendon tissue loss. Patients are treated according to standard medical care, and the study gathers data on their recovery and outcomes over time. Participants will be monitored up to two years after surgery with regular assessments including quality of life, arm and shoulder function, pain levels, and shoulder-specific scores at baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months. Additional data on retear rates, postoperative recovery, sling use, mobilization time, and return to work are also collected. The study provides long-term insight into patient progress following the use of the implant.

This research aims to collect and analyze information about babies born at 22 weeks of pregnancy in the UK to better understand their clinical care and outcomes. Since survival-focused care for these extremely premature babies has only been offered since 2019, there is limited data on how they respond to treatment and what challenges they face. The study gathers data from multiple neonatal intensive care units NICUs across the UK to improve knowledge for future care and support families. Data collection involves medical staff entering selected, anonymized information from babies medical records into a secure database. The study observes babies who are attended by neonatal teams at birth or admitted to NICUs within the first 72 hours of life. No changes are made to the babies care during the study, and a one-time survey of NICUs will assess unit approaches and equipment used for 22-week babies. Participants data, including clinical care details and short-term outcomes such as survival to discharge, are analyzed. Researchers will report on interventions across various care areas and outcomes like brain injury or infections. Parents receive information about data use, and individual babies cannot be identified in results. The study runs from admission until death or discharge from neonatal care, aiming to inform future research and improve care practices.

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.