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  • Supported Rescue Packs Post-discharge in Chronic Obstructive Pulmonary Disease

    What is the problem being addressed? Chronic obstructive pulmonary disease (COPD) is a common lung condition in the United Kingdom, with a prevalence of 4.5% in population ≥40 years and rising4. In addition to daily symptoms such as cough and breathlessness that limit physical activity, people living with COPD are prone to unpredictable deteriorations in their health called 'exacerbations'. Exacerbations are sometimes severe enough to lead to hospital admission and are often driven by infections. A systematic review of patient outcomes in COPD identified exacerbations, especially severe hospitalised exacerbations, as the aspect of COPD that patients found most difficult to live with. Prior to the pandemic there were around 115,000 admissions to hospital with COPD exacerbations per annum6 and admissions are now returning to that level. Exacerbations are more common in the winter with greater circulation of respiratory viruses, and thus the burden of hospitalised exacerbations contributes to winter National Health Service (NHS) bed pressures and cost to the NHS. The annual healthcare cost for people with moderate and severe exacerbation of COPD in England was estimated to be nearly £1 billion in 20227. A particular problem after a hospitalised COPD exacerbation is re-admission to hospital. The National Asthma and COPD Audit Programme (NACAP) has shown that the re-admission rate is 23% at 30 days and 43% at 90 days2. A systematic review conducted by the authors identified comorbidities, previous exacerbations and increased length of stay as risk factors for 30- and 90-day all-cause readmission5. There are many interventions that can reduce the risk of COPD exacerbations but these are incompletely effective8. There is also evidence to suggest that earlier intervention with standard exacerbation treatment of antibiotics and/or corticosteroids (called a 'rescue pack') can hasten recovery, with a lessened chance of hospital admission9. As part of standard NHS care2, patients with COPD should have a 'discharge bundle' implemented, although this is often poorly delivered and has not been definitively shown to impact outcomes (likely because the wrong outcomes were chosen, and the bundle was poorly implemented)10. The provision of rescue packs is not a standard component of discharge bundles but these are sometimes provided according to local service preference3. Additionally, in usual clinical practice, some patients will have been prescribed rescue packs from primary care (GP) or a community respiratory team (CRT) prior to being hospitalised with COPD. Furthermore, patients may or may not have access to rescue packs from the GP or the CRT after hospital discharge. Although rescue packs are part of NICE guidance2, the available evidence suggests they are not effective unless provided in the context of a more comprehensive management/education plan that supports patients in their appropriate use11. In practice this usually does not happen3, with evidence that a patient with COPD will receive variable or often no support; with some patients receiving rescue packs on demand without considering antimicrobial resistance, predictable side-effects from steroid overuse, or reviewing appropriateness. The investigators have pilot data that show receiving a rescue pack on hospital discharge is controversial as the hospital team is not, in general, the team that provides ongoing support to use these. There is thus recognised over- and under-use of rescue packs, associated harm from these medicines and variable provision. Providing a rescue pack, with education on how to use and support for when to use, has not been specifically tested in the high-risk 90-day period for readmission following a hospitalised exacerbation. It is the investigators' hypothesis that rescue packs on discharge in addition to a comprehensive self-supported management plan, consisting of the Asthma+Lung UK written management plan and twice weekly automated phone and or text messaging during this 90 day high risk period, will reduce readmissions by 20% compared to standard care. Why is this research important in terms of improving the health of patients and health and care services? Reducing re-admission through provision of supported rescue pack use would benefit people living with COPD and the NHS. A reduction in readmissions of 20% could save the NHS £86 million per quarter (£344 million per annum). Conversely, demonstrating that rescue packs are not effective when used in this way will address controversy about use, and reduce pressure on antimicrobial resistance and harm from over-use of oral corticosteroids. Integrated care systems are rapidly developing out-of-hospital support for people with exacerbations of COPD including digitally supported virtual wards. The proposed trial will define the role of supported rescue pack provision in the design and implementation of these programmes, enhancing their ability to reduce demands on urgent and acute care. Whether positive or negative, this trial will help to reduce the current variation in service provision by providing a definitive answer to the study question. Furthermore, preventing exacerbations of COPD have been identified as a priority by the James Lind Alliance (JLA) Priority Setting Partnership (PSP)12.

    Phase

    3

    Span

    153 weeks

    Sponsor

    Guy's and St Thomas' NHS Foundation Trust

    South Shields

    Recruiting

  • Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer

    TRACC Part B: Despite potentially curative surgery +/- adjuvant chemotherapy, a proportional of patients with early stage CRC will experience disease relapse. Current tools for surveillance, e.g., blood sampling for tumour markers (CEA) are neither sensitive nor specific. We hypothesise that detection of mutations in circulating free DNA (cfDNA) in plasma can predict relapse in patients with early stage CRC. Circulating cell free tumour DNA (ctDNA) maintains the same mutations that are present in tumour. In colorectal cancer CRC, primary tumours and& metastases exhibit high genomic concordance. Therefore the TRACC study TRACC Part B is investigating whether serial blood samples taken from in patients with stage II and III fully resected early stage CRC colorectal cancer that have undergone potentially curative surgery, blood samples to can be used to detect and& quantify ctDNA may in order to identify minimal residual disease MRD and predict relapse earlier than existing methods. CtDNA may ultimately help identify a subset of patients that are or are unlikely to benefit from adjuvant chemotherapy and could therefore safely spare some patients from receiving unnecessary chemotherapy & its associated side-effects. TRACC Part C: We hypothesis that ctDNA guided adjuvant chemotherapy administration will enable biomarker driven selection of patients who would and would not benefit from adjuvant chemotherapy and thereby reduce the proportion of patient receiving unnecessary adjuvant chemotherapy, reducing the potential side effects associated with it, but without compromising disease free survival (DFS). : This part of the study will use tThe blood test ctDNA result from a post-operative blood sample willto guide adjuvant chemotherapy treatment decisions. The study aims to demonstrate that athe de -escalation strategy of ctDNA guided adjuvant chemotherapy is non-inferior to standard of care treatment as measured by 3 year DFS in patients with high risk stage II and stage III CRC, in those who have no evidence of MRD (ctDNA negative). after surgery for patients with colorectal cancer who are following the standard of care pathway. Patients are randomised at the post- operative time point to: Arm A (standard of care adjuvant chemotherapy), or Arm B (ctDNA guided adjuvant chemotherapy) arm. For the ct DNA guided arm, patients who are ctDNA negative at this time point will have their chemotherapy de-escalated.

    Phase

    N/A

    Span

    765 weeks

    Sponsor

    Royal Marsden NHS Foundation Trust

    South Shields

    Recruiting

  • Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

    The goal of this research study is to develop an algorithm that predicts the patient's treatment outcome.This algorithm will serve as a tool for physicians when making treatment decisions, specifically for stage IV NSCLC and malignant melanoma patients receiving anti-cancer treatments. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute's standard of care. The patients will provide two blood samples and clinical data will be collected from their medical records. In the first part of the trial, the data obtained from the blood samples and the medical records of the patients will be used to develop the prediction algorithm, and in the second part of the trial, the algorithm will be validated by comparing the objective response rate of the patients to the theoretical response prediction of the algorithm.

    Phase

    N/A

    Span

    522 weeks

    Sponsor

    OncoHost Ltd.

    South Shields

    Recruiting

  • Renal Adjuvant MultiPle Arm Randomised Trial

    Phase

    3

    Span

    855 weeks

    Sponsor

    University College, London

    South Shields

    Recruiting

  • International Registry for Men With Advanced Prostate Cancer (IRONMAN)

    Phase

    N/A

    Span

    759 weeks

    Sponsor

    Prostate Cancer Clinical Trials Consortium

    South Shields

    Recruiting

  • It's Not JUST Idiopathic Pulmonary Fibrosis Study

    The overall aims of this study are - Identify biomarkers and gene expression profiles that determine progressive fibrotic lung disease regardless of aetiology - To prospectively assess biomarkers which predict progressive fibrosis in patients with fibrosing lung disease of alternate aetiology, including RA-UIP, Asbestosis, Chronic Hypersensitivity Pneumonitis and Unclassifiable fibrotic lung disease - Investigate genetic associations and epigenetic modifications which affect fibrotic disease severity and progression - Prospectively evaluate longitudinal disease behaviour in patients with non IPF-fibrotic lung diseases with a view to developing composite clinical end-points for subsequent use in intervention studies in patients

    Phase

    N/A

    Span

    209 weeks

    Sponsor

    University of Nottingham

    South Shields

    Recruiting

  • CuePD: Investigating the Effect of Personalised Auditory Cueing on Gait in Parkinson's Disease

    A researcher will contact identified participants to explain the study further and provide the approved patient information sheet (PIS, via post or email - subject to the potential participant's preference). If after reading the information the potential participant is agreeable, arrangements will be made to book a suitable date and time to visit the Clinical Gait Laboratory, Coach Lane Campus, Northumbria University. Arrangements will be made to ensure the participant has clarity on how s/he can attend the Lab e.g., mode of transport and accessibility. Upon attending the gait lab informed written consent procedures will be undertaken, then participants (n=60) will be required to answer some demographic questions, such as education level, falls history and activity level. They they will complete pen and paper based clinical assessments such as the Unified Parkinson's Disease Rating scale (UPDRS), Montreal Cognitive Assessment (MoCA), Falls Efficacy Scale-International (FES-I), Falls History Questionnaire, International Physical Activity Questionnaire and Physical Activity questionnaire for Elderly. Upon completion of the above pen-and-paper tasks, all participants will engage in walking/gait-based tests that assess the effectiveness of a personalised auditory cueing on their gait. All assessments will take place at the Coach Lane Clinical Gait Lab, Northumbria University. During the session, all participants will be asked to wear a smartphone on their person (lower-back via belt attachment), as well as a pair of headphones over their ears and a wearable sensor on each of their feet (the latter are commercial reference standard wearables will be worn on the feet as a gold standard comparison to verify gait data from the smartphone). Participants will then be asked to perform a series of forward walks around a 25m loop for 1 minute while trying to match their steps to the metronome and musical beats. Walk #1 will determine baseline stepping cadence for each participant. During walks #2-#4 the participant will listen to metronome and musical beats at a +10% increase on the cadence measured during walk #1. After walks #2 and #3, participants will (i) count backwards in their head from 30 to 0 in increments of 1 to disengage psychological responses evoked by each cueing modality and minimize any carryover effects and (ii) perform a 1 min walk with no cue at usual pace. Specifically, walks and wash-out are: - Walk 1: Walk for 1-minute at usual pace to determine baseline gait cadence (listening to no sound or no music), >> No washout, - Walk 2: Walk for 1-minute with metronome cueing set at +10% baseline cadence, >> Washout (count backwards from 30 to 0 in increments of 1 + 1min walk no cue), - Walk 3: Walk for 1-minute with instrumental music cueing set at +10% baseline cadence, >> Washout (count backwards from 30 to 0 in increments of 1 + 1min walk no cue), - Walk 4: Walk for 1-minute with vocal music cueing set at +10% baseline cadence. After the walks, all participants will be asked to answer some questions in the form of a semi-structured interview to explore their experiences of the personalised auditory cueing, administered via a smartphone (System Usability Scale). Goldsmiths Musical Sophistication Index will be used to examine participants' musical experience and skills, and provide valuable insights into the potential of the personalised auditory cueing approach to enhance gait in PwPD. Total time for lab participation is approx 1-hour. The immediate impact of personalised auditory cueing on gait performance in participants will be evaluated based on the collected data and participants' experiences.

    Phase

    N/A

    Span

    58 weeks

    Sponsor

    Northumbria University

    North Shields

    Recruiting

  • Eosinopenia in Severe COPD Exacerbation

    Blood eosinophils are a type of white blood cell that play a role in the immune system including fighting infection. They have numerous roles but are primarily involved in inflammation. They are recruited from the blood into sites of inflammation. The blood eosinophil count (BEC) can be used as a biomarker to predict whether the addition of inhaled corticosteroid (ICS) to long-acting bronchodilators (LABD) will be beneficial in reducing future COPD exacerbations. This association is based on BEC being measured when patients are clinically stable. Patients with a higher BEC are more likely to gain these benefits where as conversely, patients with a lower BEC are less likely to benefit and the risk of side effects such as pneumonia will likely outweigh any potential benefit. Current national and international COPD guidelines suggest the use of BEC as a biomarker to help inform the decision of whether to commence or withdraw ICS, but do not specify measuring BEC at a time of clinical stability. Decisions regarding changes to management are often made in the acute setting. Eosinophils transiently drop to very low levels in half of patients who are admitted to hospital with exacerbations of COPD. Measuring BEC during an acute illness risks incorrectly identifying all patients who may benefit from the introduction of an ICS. In the current BEC COPD study, reliance on admission and discharge BEC inappropriately denied ICS to 47% and 33% of patients respectively compared to a confirmed stable-state measure. There are co-primary aims for this study. Firstly, the investigators wish to determine when BEC will recover to stable state following a hospital admission for exacerbation of COPD. Determining this will inform healthcare professionals of the optimum time to measure BEC for use as a biomarker when making decisions related to management escalation. Based on the results of BEC COPD, it is likely that an increased number of patients will be identified as being above the BEC threshold and therefore likely to benefit from ICS when time is allowed for BEC to recover to stable state. Appropriate introduction of ICS in this patient group will reduce exacerbation and hospital re-admission rates and thus may reduce overall mortality within this high-risk group. This should reduce the burden of COPD on patient's health, quality of life and the NHS. Eosinopenia during severe exacerbation of COPD is associated with increased in-hospital and one year mortality. Treatment with oral corticosteroids does not fully explain the mechanism behind the development of eosinopenia, with the phenomenon being less common on discharge compared to admission despite inpatient oral corticosteroid treatment. The investigators other co-primary aim is to identify demographic, physiological and clinical factors independently associated with admission eosinopenia in patients with a severe exacerbation of COPD, providing useful mechanistic information regarding the relationship between BEC and short-term mortality. The hypothesis for this study is that 90% of participants who are admitted to hospital with a severe exacerbation of COPD and eosinopenia will have recovery of their BEC to baseline stable state within 4 weeks. The investigators also hypothesize that there are demographic, physiological and clinical factors independently associated with admission eosinopenia other than prior systemic corticosteroid use.

    Phase

    N/A

    Span

    132 weeks

    Sponsor

    Northumbria Healthcare NHS Foundation Trust

    North Shields

    Recruiting

  • Study of RSO-021 in Patients With Malignant Pleural Effusion Due to Advanced/Metastatic Solid Tumors Including Mesothelioma

    This is a Phase 1/2, open-label, multi-center study whose primary Phase 1 stage objective is to determine the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) of RSO-021 (thiostrepton), a naturally-occurring, sulfur-rich, cyclic oligopeptide antibiotic of the thiopeptide class, in patients with MPE from any solid tumor, including mesothelioma. In the Phase 2 stage, once the RP2D has been identified, the antitumor activity of RSO-021 will be evaluated in four recruitment arms; (1) in patients with MPE (non-mesothelioma), (2) in patients with MPE (non-mesothelioma) in combination with paclitaxel, (3) in patients with MPE from mesothelioma after first-line SoC, and (4) in patients with MPE from mesothelioma who have a 'window of opportunity' for treatment prior to first-line systemic therapy.

    Phase

    1/2

    Span

    157 weeks

    Sponsor

    RS Oncology LLC

    North Shields

    Recruiting

  • Brain Activity During Gait in Parkinson's

    Phase

    N/A

    Span

    113 weeks

    Sponsor

    Northumbria University

    North Shields

    Recruiting

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