ANZCTR search results

This study will evaluate whether a pop-up “Heart Health Check” can be used to feasibly and acceptably screen adults in the Springfield community for previously unrecognised cardiometabolic risk. Adults aged 18 years and over who attend a pop-up screening session will complete a brief questionnaire and screening measures including glycated haemoglobin, blood pressure, body measurements, and liver health assessment using FibroScan, and will receive a printed summary of their results. Participants will also be invited to complete a brief online follow-up questionnaire 2 weeks later about any health-related actions they took after screening, how useful they found the screening, and any barriers to follow-up. The study is expected to provide early evidence about the feasibility and acceptability of this community screening model, the burden of cardiometabolic risk identified, and whether receiving personalised screening results prompts short-term follow-up action. It is hypothesised that the pop-up screening model will be feasible and acceptable and will identify a meaningful burden of previously unrecognised cardiometabolic risk in this community

Currently, endometriosis is diagnosed by invasive surgery (laparoscopically followed by histopathology), or severe disease may be detected by imaging modalities (ultrasound or MRI). No early, non-invasive diagnostic test exists for endometriosis. This prospective study aims to explore the use of fluoro-17beta-estradiol PET/CT imaging as a potential non-invasive, early diagnostic test for endometriosis relative to surgical/histological outcomes. We hypothesize that PET/CT imaging with fluoro-17beta-estradiol has potential application in the diagnosis of endometriosis.

What the study is about: This study aims to find out whether a short course of the medicines polatuzumab vedotin (PV) and rituximab, with or without targeted radiotherapy, can better control lymphoma while patients wait for their personalised CAR-T cell therapy with Tisa-cel. Many people with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) have fast-growing disease, and some may become too unwell to receive CAR-T treatment during the manufacturing period. Early control of the lymphoma during this waiting time—called bridging therapy—may help improve the chances that CAR-T therapy works well. Who is this trial for: • 18 years of age or older with a prior diagnosis of DLBCL, • Have had the cancer return after two or more treatments, • You are eligible to receive CAR-T cell treatment and have already had leukapheresis. Study Details: This is a single arm, open label, phase 2 study. Participants will receive bridging therapy before CAR-T cell treatment with: • Polatuzumab vedotin (PV) administered intravenous (IV) on Day 1. • Rituximab administered IV on Day 1. • Depending on the wait time for Tisa-cel manufacture, a 2nd dose of PV and rituximab can be administered on day 22. • Radiotherapy may be added if your doctor recommends it. This study will recruit a total 47 participants across Australia, Taiwan, Hong Kong, and South Korea. What is hoped from it: This trial will help determine whether a more effective and tolerable bridging strategy can keep patients well enough for CAR-T therapy and improve their long-term outcomes.

Brief description of the study purpose: This study is investigating a personalised mRNA vaccine for children and young people with high risk central nervous system tumours. The vaccine is made individually for each participant using information from their tumour and is designed, based on laboratory and preclinical research, to help the immune system recognise proteins associated with the tumour. Who is it for? You may be eligible if you are male or female 6 months to 25 years old, have a high-risk central nervous system tumour, and are enrolled in the ZERO Childhood Cancer molecular profiling program, you have measurable disease (with some exceptions for newly diagnosed cases), a Karnofsky/Lansky score of more than 50, a life expectancy of at least 12 weeks, have recovered from prior therapy according to required washout periods, and have adequate blood counts, kidney function, liver function, and coagulation. You must not have a known hypersensitivity to mRNA vaccines, not be pregnant or breastfeeding and have no underlying congenital immunodeficiency. You must not be taking corticosteroids other than physiologic replacement doses and have no live vaccines within 3 months of starting protocol therapy. Study details Those who are eligible for phase I will receive four escalating doses (from 50 up to 200 micrograms), followed by additional fixed-dose injections and a six-month booster to determine the highest dose they can tolerate. If the maximum planned dose of 200 micrograms is safe, the next three participants will receive all doses at that level. However, if any dose-limiting toxicities occur, the trial will switch to a standard 3+3 dose-escalation design to identify the recommended Phase II dose. Study participants will be required to have periodic brain imaging and blood and urine tests. It is hoped that result from this study will assess the safety and efficacy of the vaccine.

This project will evaluate the Social Brain Toolkit Virtual Clinic, a new service delivery model involving implementation of previously developed interventions targeting communication after traumatic brain injury (TBI), within a student speech pathology clinic and with integration of peer mentors with TBI. The primary objective of the current study will be to test the efficacy of the Virtual Clinic for improving social participation, health-related quality of life, and communication after TBI, compared to provision of self-guided resources. A secondary objective is to explore whether the Virtual Clinic is more cost-effective than self-guided resources for people with TBI in terms of quality-adjusted life years saved over 18 and 30 weeks, from an Australian public health care system perspective. A final aim is to examine what individual / contextual factors influence the implementation of the Virtual Clinic.

With traditional randomised controlled trials (RCTs) generation of evidence is inefficient, facing high costs and lengthy set-up times. Traditional RCTs also encounter recruitment challenges and are restricted to answering only one specific question about one single intervention resulting in limited insights and slower evidence generation to enhance consumer outcomes. To develop more effective treatments and improve the speed, cost and number of randomised evaluations of promising treatments for schizophrenia, the Schizophrenia Platform for Improving Recovery with Integrated Trials (SPIRIT), underpinned by the current Master protocol, will use innovative trial design and statistical methods to evaluate multiple treatments simultaneously, improving affordability, speed, and applicability. By streamlining infrastructure setup and utilising comparator information, it will require fewer participants and adapt to new treatments as they become available and increase the likelihood of beneficial treatment.

The aim of the ‘Measure It!’ trial is to investigate whether very brief measurement of physical activity on 5 occasions over 6-months is more effective than usual care in improving physical activity in people with cancer undergoing chemotherapy. Who is it for? You may be eligible for this study if you are 18 years or older and have any cancer diagnosis that is suitable for chemotherapy treatment for more than 4-6 months. Study details Participants in this study will be allocated to one of the following two groups, by chance: Group 1: Participants will receive the 5-minute physical activity intervention (Measure It!) approximately every 6 weeks (5 times) over 6 months in their chemotherapy sessions or via phone, The Measure It! intervention will be delivered by one of their cancer care clinicians, for example, nurse, physiotherapist, exercise physiologist, or oncologist, Group 2: Participants will continue to receive chemotherapy treatment as part of their usual care. All participants will be asked to complete questionnaires and wear an activity monitor for one week at the beginning of the study and at 3 and 6 months after starting the study. This study will provide preliminary data to indicate if Measure It! is more effective in improving physical activity than usual care over 6-months to inform a larger trial. Ultimately, we hope that our results will drive changes in current practice, encouraging more clinicians across Australia to deliver Measure It! in Chemotherapy Day Units, leading to improved health for many Australians with cancer undergoing chemotherapy.

This study will assess the feasibility of using a digital rehabilitation support platform to assist recovery in patients undergoing total hip replacement (THR) or total knee replacement (TKR). Participants will receive usual physiotherapy care and access to a mobile application that provides exercise programs, education, and reminders to support rehabilitation before and after surgery. The study will evaluate whether the platform is acceptable and usable for patients, and whether study processes such as recruitment, retention, and data collection are practical to support a future larger study. Participants will complete online surveys before surgery and at 4 and 12 weeks after surgery, with a subset invited to take part in an optional interview to provide feedback on their experience. Findings from this study will help inform the design of a future larger trial and explore whether digital rehabilitation support may improve access to physiotherapy, particularly in regional and rural settings.

Established treatments for radiation cystitis (diathermy, hyperbaric oxygen and intravesical instillations) have high failure rates and complication rates. RADA 16 is approved for and has been used extensively for haemostasis in surgery. Protocols for its use in the treatment for radiation proctitis are also well established. For radiation cystitis there is a single case report and a case series (of which the CPI is the primary author) for UK patients. These have both demonstrated good outcomes for patients who otherwise are facing either palliation or complex, salvage surgery which many of these patients may not be fit to undergo. More research is needed to establish if this is a treatment that would be beneficial for a cohort of patients with refractory haematuria from radiation cystitis, a debilitating condition often requiring substantial use of hospital resources.

This study aims to examine whether a brief, self-guided writing activity focused on personal memories can improve mood in older adults. Many older adults experience low mood that does not meet criteria for clinical depression but still affects their wellbeing, and there is a need for simple, accessible strategies that can help. In this study, participants will be randomly assigned to either complete a short, structured reminiscence writing task or to a comparison (control) condition. The writing task will guide participants to reflect on meaningful past experiences, with a focus on moments of personal strength, coping, and achievement. We expect that participants who complete the reminiscence writing task will show greater improvements in mood compared to those in the control group. We also expect that these improvements will be partly explained by an increased sense of mastery (i.e., feeling more in control of one’s life and able to handle challenges). The findings may help identify a simple, low-cost, and private intervention that could support emotional wellbeing in older adults.