ANZCTR search results

Coronary artery disease can occur even in people without the traditional risk factors such as high cholesterol, diabetes, smoking, or high blood pressure. Per- and polyfluoroalkyl substances (PFAS) are manufactured chemicals that may contribute to the development of coronary artery disease, but it is not currently known whether reducing PFAS levels improves heart health. The purpose of this study is to determine whether regular plasma donation over 12 months can reduce PFAS levels and slow the progression of coronary artery disease in adults with greater PFAS exposure levels and evidence of non-calcified plaque in their coronary arteries. Participants will be randomly assigned to either begin plasma donation immediately or after a 12-month delay. The hypothesis is that reducing PFAS levels through regular plasma donation will slow the progression of coronary artery plaque compared with deferred plasma donation.

In this randomised, double-blind, placebo-controlled study, 120 adults aged 18 years and older experiencing at least mild depressive symptoms and elevated psychological distress will be randomly assigned to receive one of two doses of Hedonia or a matching placebo for 8 weeks. Hedonia is a nutritional supplement containing omega-3 fatty acids, S-adenosyl-L-methionine (SAMe), and L-methylfolate. The primary aim is to determine whether Hedonia reduces overall psychological distress, including symptoms of depression, anxiety and stress, compared with placebo. Changes in depressive symptoms, mental wellbeing, mood, sleep quality and energy levels will also be assessed throughout the study. All assessments will be conducted remotely, and treatment adherence, tolerability and adverse events will also be evaluated.

This study is a clinical trial in healthy volunteers to understand how safe AP03 is and how the body processes it. AP03 is an investigational medicine being studied to help slow lung scarring and preserve lung function in people with idiopathic pulmonary fibrosis (IPF). Healthy volunteers will be randomly assigned to receive either AP03 or a placebo in single ascending dose (SAD) or multiple ascending dose (MAD) cohorts. Doctors will closely monitor participants for side effects. The study uses gradual dose increases, small participant groups, and close medical supervision to help ensure participant safety before progressing to higher dose levels.

This study aims to find the highest dose of an investigational drug called Sapu006 that can be given safely. Sapu006 is a new form of the chemotherapy drug docetaxel. It packs docetaxel into tiny particles so it doesn’t need to be dissolved in a solvent, which may cause side effects in some patients. Laboratory studies suggest Sapu006 behaves in the body much like standard docetaxel. This study will check its safety and measure how the body handles it. The study will also look at whether the amount of a protein called albumin in the blood and in the tumour is linked to how well the treatment works. Who is it for? You may be eligible for this study if you are an adult aged 18 years or older with one of the following conditions: locally advanced or metastatic breast cancer that has grown after previous chemotherapy advanced or metastatic non-small cell lung cancer that cannot be removed by surgery and has grown during or after platinum-based chemotherapy metastatic castration-resistant prostate cancer metastatic epithelial ovarian, fallopian tube or primary peritoneal cancer, with no more than 2 previous lines of chemotherapy. You will also need a blood albumin level of at least 4.0 g/dL and a suitable sample of your tumour. A study doctor will do health checks to confirm whether you can take part. Study details All participants will receive Sapu006 as a 1-hour infusion into a vein once every 3 weeks. Before each infusion, participants will receive medicines to help prevent allergic reactions. Depending on the type of cancer you have, you may also receive a second, approved cancer medicine that is commonly given with docetaxel: Participants with breast cancer or non-small cell lung cancer will receive Sapu006 alone. Participants with prostate cancer will also take prednisone tablets. Participants with ovarian, fallopian tube or primary peritoneal cancer will also receive an infusion of carboplatin (another chemotherapy drug) straight after the Sapu006 infusion. The first participants will receive a low dose of Sapu006. A safety committee will review the results for each small group of participants before higher doses are given, and the dose can also be lowered if needed. Treatment can continue for as long as it is helping and the side effects are manageable. During the study, participants will have regular check-ups, blood tests and scans, and will be asked to report any side effects. In the first 2 treatment cycles, extra blood samples will be taken to measure Sapu006 levels, and participants may need to stay in hospital for up to 2 days after the infusion. A stored sample of each participant’s tumour will be tested for albumin gene activity. If no stored sample is available, a new biopsy may be taken if it is safe to do so. It is hoped this research will identify a safe dose of Sapu006, given alone or with prednisone or carboplatin, for future trials. It will also give an early indication of whether Sapu006 can help control these cancers.

A difference in leg length is an important concern for some patients following total hip replacement, but measurements on medical imaging do not always reflect what patients actually feel. This prospective study will follow adults undergoing primary total hip replacement and compare measurements of leg length, pelvic alignment and hip reconstruction on medical imaging with whether patients perceive a difference in their leg lengths after surgery. Participants will complete questionnaires before surgery and during follow-up, and imaging measurements will be collected before and after surgery. We hypothesise that greater radiographic leg-length imbalance will be associated with a greater likelihood of patients perceiving a leg-length difference at 12 months. The study aims to identify which measurements best reflect patients' perception of leg length and may help improve assessment and management of leg-length discrepancy after total hip replacement.

This study will offer patients that had open heart surgery and their family members a genetic test to investigate their high cholesterol and improve their treatment. We are hoping to evaluate how effective this strategy is for identifying patients with a genetic condition so that they can be offered treatment and enrolment in a registry.

Cardiovascular disease (CVD) remains a leading cause of death and there is a need to better understand modifiable risk factors, such as a dysfunctional autonomic nervous system (ANS). Preliminary data suggest there may be a difference in the size of the coeliac ganglia (CG) in people with prevalent hypertension and CVD, suggesting that CG size may be an indicator of a dysfunctional ANS. We propose that measuring the CG size by MRI imaging may be a non-invasive technique for understanding a person’s chronic exposure to a dysfunctional ANS. Furthermore, we propose that a molecular imaging technique, using Gallium-68 prostate-specific membrane antigen positron emission tomography (Ga-68 PSMA PET) imaging, can identify glutamate metabolism in the coeliac ganglia and may represent a real-time measure of ANS dysfunction. In this prospective case-control study, we are inviting three groups of people with differing levels of expected ANS dysfunction, to undergo MRI of the abdomen and Ga-68 PSMA PET/CT imaging. Group 1 participants will have resistant hypertension and cardiovascular disease (n=15), group 2 participants essential hypertension (n=15) and group 3 are a control group with no hypertension and no cardiovascular disease (n=15). All participants will also undergo muscle sympathetic nerve activity (MSNA) testing as a gold standard of ANS dysfunction. The study will compare the size of the coeliac ganglia, and glutamate metabolism of the coeliac ganglia, across the three groups and with MSNA measures.

Title: AMLM28-A4. Achieving Durable remissions via Adaptive Pro-survival Targeting in Acute Myeloid Leukaemia (AML)-VEN/AZA/Lasmotinib: A therapeutic arm of the ALLG AMLM28 ADAPT study. Purpose of this trial: This treatment arm is part of the AMLM28 ADAPT “platform” trial, where many treatment options are being explored for participants who are being treated with the standard of care (SOC) drugs Venetoclax (VEN) and Azacitidine (AZA). These participants are being treated with VEN-AZA because intensive chemotherapy is not considered an appropriate treatment option for them. The goal is to find out if adding a new drug, lasmotinib, can help participants live longer without the disease returning or worsening. About 20% of newly diagnosed AML patients will have a gene mutation called FLT3-ITD. FLT3 is a gene that tells blood cells when to grow. FLT3-ITD is a mutation where the FLT3 gene has been duplicated, causing the gene to be permanently switched on and leukaemia cells to grow out of control. Lasmotinib works by blocking this signal, helping to slow the growth of the leukaemia cells and improve disease control. Who is this trial for? You may be eligible for this trial if you are: • A newly diagnosed AML patient enrolled on the AML28 ADAPT trial. • Eligible to receive SOC VEN-AZA treatment • Have an abnormality on a specific gene, FLT3-ITD. • Have been tested for another gene called NPM1. Trial details: A4 treatment arm: There will be 12 cycles of treatment, with each cycle lasting for 28 days. Azacitidine is given either as an injection under the skin or through a vein for 7 days. Venetoclax is taken orally once a day for 21-28 days. This study will begin with a small group of participants (n=12) to find the safest dose of lasmotinib that can be added to SOC VEN-AZA treatment. Lasmotinib is taken orally once a day from day 8-day 28. The study is then expanded to recruit an additional 60 patients for a total of 72 patients in Australia only. Participants will be randomised to either receive SOC VEN-AZA or VEN-AZA with lasmotinib. If a participant is benefiting from treatment and wants to continue treatment past 12 cycles, this can be requested. Participants will be followed up for a year, every 3 months, after they have completed 12 cycles of treatment. Long term follow up data will be captured through the ALLG National Blood Cancer Registry (NBCR). This new approach could lead to better, more personalised treatment for people with AML who can’t have intensive chemotherapy. It aims to improve long-term outcomes and change how AML is treated in Australia.

Semaglutide use in adults with obesity and previous cardiovascular disease has been shown to reduce further cardiovascular events, however the exact mechanism is uncertain. Whether semaglutide exerts effects on the heart quickly after medication commencement is unknown. One parameter which may be rapidly affected is the energy state of the heart, which can be measured using an advanced cardiac MRI scan. This is a randomised trial to assess this occurs and to what degree.

Many people receiving dialysis feel lonely or cut off from others, and social prescribing connects people with activities, groups and services in their local community. This pilot study will test whether a social prescribing program is feasible for adults receiving dialysis at four units in Western Sydney, Australia. Fifty participants will be randomly assigned to one of two groups: the social prescribing program, or their usual care. In the program, a link worker with lived experience of kidney failure makes a plan with each person to join one or two community activities and calls them regularly over 3 months. We expect that at least half of eligible patients will agree to take part and at least 8 in 10 will stay in the study to 3 months; we will also measure loneliness, social isolation, life participation, fatigue, hospital admissions, changes in dialysis type, survival and costs.