ANZCTR search results

This study aims to identify biological markers in tumour and blood samples which may predict clinical outcomes and responses to treatment for people with a variety of cancer types, including but not limited to melanoma, lung cancer, breast cancer, colorectal cancer and genitourinary cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older and you have been diagnosed with a solid organ cancer, including but not limited to melanoma, lung cancer, breast cancer, colorectal/bowel cancer, cervical cancer, ovarian cancer, or liver cancer. Study details All participants who choose to enrol in this study will be asked to consent to having their health information (collected as part of their diagnosis and treatment) accessed by the research team. Participants who have already had tumour samples taken will be asked to consent to having some of these samples used for additional testing to determine if their tissue expresses any cancer-related genes or other biological markers. They will also be asked to provide blood samples prior to starting their cancer treatment, and again at 1 month, 3 months, 6 months, and 12 months after starting their cancer treatment. Participants may also choose to continue to provide additional blood samples every 3 months for another 3 years after starting their cancer treatment, if they wish. All samples collected for this study will undergo a range of different assessments to identify any cancer-related genes or other biological markers. Tumour and blood samples will be collected from participants as part of their routine treatment and follow-up. This means no additional blood tests or biopsy procedures will be required for this research project. It is hoped this research will identify new biological markers that can be used to determine how cancer patients may respond to different treatments, or their risk of cancer relapse post-treatment.

The pandemic has significantly impacted the day-to-day lives of many children, their families, and schools, which has resulted in increased levels of anxiety, depression, social isolation, and loneliness among young people. An integrated public health model of interventions is needed to address the problem and to safeguard the mental health and wellbeing of children. The Triple P – Positive Parenting Program is a system of evidence-based parenting with a strong evidence-base and wide international reach. When implemented as a public health approach, this program has demonstrated positive effects on child wellbeing at a population level. The current study is the first large-scale, multi-site randomised controlled trial of a newly developed, low-intensity variant of Triple P, a schools-based seminar series, as a response to the impacts of the pandemic. The evaluation will employ an Incomplete Batched Stepped Wedge Cluster Randomised Trial Design. At least 300 Australian primary schools, from South Australia, Queensland, and Victoria will be recruited and randomised in three batches. Within each batch, schools will be randomly assigned to either start the intervention immediately or start in six weeks. Parents will be recruited from participating schools. The Triple P seminar series includes three seminars titled: “The Power of Positive Parenting”, “Helping Your Child to Manage Anxiety”, and “Keeping your child safe from Bullying”. Parents will complete measures about child wellbeing, parenting, parenting self-regulation and other key intervention targets at baseline, six weeks after baseline, and 12 weeks after baseline. Intervention effectiveness will be evaluated with a Multilevel Piecewise Latent Growth Curve Modelling approach. Based on the strong evidence for the more intensive versions of each of the seminars, we anticipate finding improvements in primary intervention targets, including child social, emotional, and behavioural wellbeing, general parenting practices, and parenting self-efficacy/self-regulation. We also expect to find improvements in secondary outcomes such as child anxiety, depression, family adjustment, and specific parenting practices that facilitate child anxiety. The findings from this study will extend the current knowledge of the effects of evidence-based parenting support delivered through brief, universally offered, low intensity school-based parenting seminars in a post pandemic world.

This platform trial aims to provide an overarching research framework that will enable research questions to be addressed prospectively and systematically for AML patients receiving VEN-AZA. Domain 1 of the AMLM28 ADAPT platform trial aims to determine the utility of adding navitoclax to VEN-AZA for patients with suboptimal response to VEN-AZA by offering therapeutic interventions for patients with TP53 aberrations or MRD persistence.. Who is it for? You may be eligible for this study if you are aged 18 and above and have been diagnosed with AML. Study details Domain 1 (ADAPT-Rx) consists of two different strata: - TP53 stratum - Patients who are found to have TP53 aberrations during or after cycle 1 may be eligible - Measurable Residual Disease (MRD) persistence stratum Participants who are eligible to commence Domain 1 ADAPT-Rx therapy for either strata will receive an oral dose of navitoclax once daily for 7 days prior to commencing the VEN-AZA and Navitoclax (from day 6) treatment cycle, All patients will initially be enrolled into the AMLM28 Master Protocol. If during or after cycle 1 VEN-AZA, the patient is found to have one or more TP53 aberrations, the patients may be assessed for eligibility to commence Domain 1 ADAPT-Rx therapy (TP53 stratum). If after cycle 4, the patient is found to have persistent MRD by flow cytometry, the patient may be assessed for eligibility to commence Domain 1 ADAPT-Rx therapy (MRD persistence stratum). If more than 1 treatment arm is open to recruitment in domain 1, and if the patient is eligible for more than 1 treatment arm, the patient will be randomised to one of the available treatment arms. The patient will then be given the consent form for that treatment arm and screened. If the patient passes screening, they will be registered to that treatment arm. If the patient fails screening, they will be randomised to another treatment arm and screened accordingly. It is hoped this research will deliver adaptive interventions to improve clinical outcomes in patients receiving frontline VEN-AZA for newly diagnosed AML.

The aim of the study is to evaluate the efficacy and feasibility of a conversational artificial intelligence (AI) intervention comprising automated phone calls and text messages to improve quality of life and self-management of patients with atrial fibrillation (AF). The hypothesis is that this program will better support patients with AF, improving their quality of life and overall health management and risk factors.

Multiple sclerosis (MS) is a potentially devastating disease of the central nervous system and progressive MS, which occurs in up to two-thirds is the most severe form. Current therapies for MS have limited effect in the progressive stage. Recent studies have confirmed that the primary cause of MS is latent infection with Epstein-Barr virus (EBV). We have conducted a systematic review of existing drugs with potential anti-EBV effects. Through an internationally peer reviewed process we have selected two promising agents with known acceptable safety profiles and proven efficacy against EBV. In order to maximise efficiency to find the best such treatment we have partnered with experts in the UK in designing a state of the art trial to test these agents in progressive MS. We propose to run an innovative adaptive phase III clinical trial to evaluate the effectiveness of promising anti-EBV therapies for progressive MS by repurposing old drugs (Spironolactone and Famciclovir) for a new indication. In stage 1 we will compare the effect of the two agents against dummy-treatment (placebo) in their ability to reduce antibodies to EBV and the amount of EBV shed in saliva in relatively small numbers (total 150) over 6 months. The agent that produces the largest reduction in these measures will then progress to state 2, where the clinical effectiveness of this treatment will be compared to placebo over a period of 3 years in a larger group (total 300). This study will facilitate the participation of Australians with progressive MS in a novel trial of anti-EBV therapies. If the outcomes of this study are positive then the impacts would be immense. It has been noted that the lack of treatment for progressive forms of MS is the single greatest unmet need for people with MS. The advent of an effective therapy to prevent further progression or even improvement would be a huge step forward. There would be similar implications for the wider MS community.

More than 20,000 heart operations are carried out each year in Australia. While most patients survive their surgery, many spend a long period of time in hospital recovering. Delayed recovery may happen as a result of the complexity of the surgery, or due to medical problems that occur after the operation such as irregular heart rhythms, stroke or kidney failure. These medical problems following surgery are known as postoperative complications. Postoperative complications can lead to long-term ill health and loss of independence, as well as prolonging hospital stay. In addition, a longer stay in hospital may expose patients to risks such as infection and predispose to physical deconditioning. Reducing length of stay in hospital is associated with improved recovery from surgery, in addition to reduced healthcare costs. Previous studies have suggested that a new drug called ‘angiotensin II’ can successfully be used to treat low blood pressure in critically unwell patients. Drugs to preserve blood pressure are also often needed in heart surgery, however there are no large studies that have assessed the effectiveness of angiotensin II in patients during and after heart surgery. We previously carried out a small study that showed that using the drug angiotensin II during and after cardiac surgery is possible (ACTRN12621000195853). This knowledge has allowed us to design a new study to compare the use of angiotensin II to the current standard drug used to treat low blood pressure after heart surgery, called noradrenaline. In our previous research, patients who were given angiotensin II had fewer postoperative complications (although this difference wasn't statistically significant) and shorter lengths of stay in hospital. However, before we can recommend that angiotensin II is better for treatment of low blood pressure during cardiac surgery, we need to confirm these findings in a much larger study to make sure that our previous study findings were not simply the result of chance. In this study we will assess whether the administration of angiotensin II reduces length of hospital stay compared to noradrenaline.

Neck pain is disabling and characterised by recurrent pain episodes. Treatment is often delivered by health practitioners. This study aims to enhance proprioception for people with neck pain to enable self-recognition of potential contributing factors to the perpetuation of their condition; reduced pain and disability; and, improved internal locus of control. The intervention consists of x5 1-hour physiotherapist-guided group exercise and education sessions; a daily home exercise program (under 30-minutes); and journaling. The program will be assessed by collecting information regarding pain, disability, locus of control, and participant experience of the intervention.

This is a randomised controlled, parallel design, single-blinded trial to examine the efficacy of a novel EEG neurofeedback intervention in comparison with the control condition for individuals with neuropathic pain after SCI. Participants will be randomised to receive EEG neurofeedback (Treatment condition) or ‘treatment as usual’ (Control condition). Participants in the treatment condition will complete a session of EEG neurofeedback once a day for 20 days over a 4-week period. Each session will comprise 5x2.5-minute blocks of EEG neurofeedback with a break of up to 30 seconds between each block. Participants in the control condition can continue with all the treatment options that they would normally have access to in the community. We hypothesise that 1) EEG neurofeedback intervention will show greater reduction in self-reported pain intensity for people with neuropathic pain after SCI following the intervention compared to the control condition. 2) Completion of the EEG neurofeedback intervention may be associated with pre- to post-intervention improvement in psychosocial factors.

Cognitive ability, including memory and problem solving, declines with normal aging. For some people, this decline is more rapid, resulting in a condition known as mild cognitive impairment (MCI). MCI is a precursor for neurological conditions including dementia and Alzheimer’s disease. Despite considerable biotechnology and pharmaceutical investment, current pharmacological treatments for these conditions only temporarily alleviate symptoms with some 50% of people diagnosed showing no benefit with treatment. A growing body of research suggests alternative therapies such as photobiomodulation (PBM) and hyperbaric oxygen therapy (HBOT) may offer benefits to both the symptoms and progression of neurodegenerative diseases. This research will assess whether PBM, also called red light therapy, is an effective treatment for mild to moderate cognitive impairment and whether this effect is heightened by the combined treatment of HBOT. Treatment involves PBM therapy either alone or with HBOT for 8 or 16 weeks depending on treatment arm. Trial participants will undergo MRIs, cognitive tests and a series of blood tests at various time points over a 6-month period to assess immediate and long-term effects of PBM and HBOT on brain structure, function, and cognition. This study is exploratory and will provide important insights for future studies.

Crohn's disease (CD) is a chronic inflammatory disorder with increasing prevalence worldwide. Of note, Australia has one of the highest rates in the world with over 40,000 Australians affected. Ustekinumab (UST) is a monoclonal antibody targeting IL-12 and IL-23 through their shared p40 subunit. UST was approved for the treatment of moderate to severe CD in Australia in September 2017. Currently, there is a paucity of studies into the use of UST in bio-naive patients, and knowledge regarding the predictors of response to UST therapy are limited. Data investigating the utility of UST in real-world clinical practice is also lacking. As there are no Australian prospective studies to date, this prospective national multicentre observational cohort study will explore clinical factors and biomarkers in Australian cohort that may aid in clinical decision making to indicate which patients are likely to respond to therapy - a key answered question in the field of inflammatory bowel disease management.