Burnley

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 studying patients with rotator cuff injuries who are undergoing arthroscopic rotator cuff repair surgery. This study collects real-world data on the outcomes of using the REGENETEN Bioinductive Implant System, a medical device designed to manage and protect rotator cuff tendon injuries where there has been no significant loss of tendon tissue. The registry involves multiple centers across the United Kingdom, Europe, and Australia and plans to enroll up to 400 patients. Participants will receive arthroscopic rotator cuff repair surgery augmented with the REGENETEN Bioinductive Implant as part of their standard medical care. The implant is intended to support tendon healing in either partial or full thickness tendon tears. This is a prospective, single-arm study without a comparison group, focusing on collecting data after surgery. Patients will be followed and evaluated at multiple time points up to two years after surgery. Assessments include quality of life, arm and shoulder function, shoulder pain levels, and overall shoulder evaluation using several validated scoring systems. Data will be collected at baseline before surgery and at 2 weeks, 6 weeks, 3 months, 6 months, 12 months, and 24 months post-surgery to monitor recovery and outcomes over time.

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.