ANZCTR search results

What is the purpose of this research? The PROXIMITY study is a national, multi-site research project aiming to better understand how prostate cancer develops, progresses, and responds to treatment. By collecting clinical data, patient-reported outcomes, and optional biological samples, the study seeks to improve the care and outcomes of men with prostate cancer. The study follows a master protocol, with flexible sub-studies introduced over time to address specific research questions. This registration describes the overall PROXIMITY study and its first two sub-studies: HOROSCOPE and PROCAP. Who can take part? You may be eligible to participate if you are aged 18 years or older and have been diagnosed with prostate cancer. Each sub-study will have its own eligibility criteria to determine who can take part. What’s involved? If you agree to take part, depending on your eligibility and consent for specific sub-studies, you may be asked to: Allow researchers to access your prostate cancer-related medical records Complete online surveys about your health, symptoms, and quality of life Optionally provide blood or tissue samples, if available via your treating team Participation in the PROXIMITY master study allows for the possibility of being invited to future sub-studies over the 10-year study period. You can choose to join any sub-study you are eligible for given they would be available at your treating site. What are the sub-studies about? HOROSCOPE investigates how changes in specific DNA repair genes (such as BRCA1, BRCA2, and other homologous recombination repair genes) affect treatment outcomes in patients with metastatic or high-risk localised prostate cancer. This involves retrieving archived tissue for genomic testing—no extra visits or procedures are required. PROCAP looks at how cultural background and language preferences influence prostate cancer care. It involves completing surveys over a 2-year period to understand how different patient experiences and backgrounds may impact care and quality of life. Please note: All PROXIMITY sub-studies are observational only. No treatments are provided through participation. Why is this research important? Your participation will help researchers understand the diverse experiences of men with prostate cancer, including how different treatments affect quality of life. The findings may lead to more personalised, culturally responsive care in the future.

This is a phase 1, open-label, study to evaluate the safety, pharmacokinetics, and pharmacodynamics 225 IU GB-hMG over 7 consecutive days in healthy premenopausal women. Up to twenty eligible, healthy volunteers will receive one (1) subcutaneous (SC) injection of 225 international units (IU) per day for seven (7) consecutive days to evaluate the safety, pharmacokinetics, and pharmacodynamics of GB-hMG.

This study will evaluate the efficacy of a blended care intervention (which combines a smartphone app called myNewWay with up to 10 psychological therapy sessions) for adults with anxiety disorders compared to a usual care control group, and a group who receives a self-guided version of myNewWay. The primary aim of the trial is to compare the efficacy of the blended care and usual care control groups in the reduction of anxiety. The secondary aims are to compare the efficacy of blended care to the control group in changing other symptoms and outcomes (eg quality of life, depression), compare the blended and self-guided groups in reducing anxiety, and other outcomes, as well as compare the acceptability, engagement and satisfaction of blended care versus self-guided care. Participants will be assessed at baseline, week 6, week 12, and week 24 on self-report outcome measures. People randomised to the control group will receive the self-guided myNewWay program after completing the week 12 self-report outcome measures. The study is Australian based, done online, so recruitment will cover all states and territories of Australia.

The study aims to examine the impact of dietary fibre on markers of gastrointestinal integrity, function, and symptoms in response to physical exertion. This will be done by comparing the effects of consuming a low- or high-fibre diet for two days before running in hot temperatures. Additionally, the study will assess how consuming a kiwiberry gel (containing carbohydrates, fibre, and FODMAPs) during exercise influences gastrointestinal integrity, function, and symptoms. Markers of gastrointestinal perturbations and perceptive gastrointestinal symptoms will be measured to better understand how these dietary factors impact gut health and performance during exercise in the heat.

This project aims to evaluate the efficacy, fiesability and acceptability of conducting a 12-session imagery rescripting intervention (an emotion-focused, cognitive-behavioural technique) with a sample of individuals diagnosed with hoarding disorder, in order to inform the suitability and design of a larger, future randomized controlled trial. It is hypothesised that the imagery rescripting intervention will produce reductions in clinical symptom severity among individuals with a primary diagnosis of hoarding disorder. The research questions that this study seeks to address are: 1. Do participants with hoarding disorder report any benefits of participation, particularly in terms of symptom reduction? 2. What are the estimated recruitment and retention rates during the intervention and follow up periods? 2. Is the intervention credible and acceptable to participants? 3. Do participants report any harms or adverse events associated with imagery rescripting?

Breathing and coughing difficulties are extremely distressing for people living with MND, and therapies that improve breathing capacity and related symptoms are needed. This research project will evaluate whether combining two breathing therapies together (lung volume recruitment with expiratory muscle strength training) is feasible and acceptable to people living with MND and clinicians (e.g. physiotherapists trialing the intervention with people). This observational study will also collect information about whether the combined therapy improves breathing and cough symptoms in people affected by MND.

This study aims to assess the safety of the study imaging tracer in Participants with Advanced Solid Tumours. The study imaging tracer is a radioactive tracer that is used to assist with visualising tumors during a specific type of PET scan. Who is it for? You may be eligible for this study if you are aged 18 years or above with advanced or metastatic triple negative breast cancer, squamous non-small cell lung cancer, oesophageal squamous cell cancer or head and neck squamous cell cancer. Study details All participants who choose to enrol in this study will be asked to attend a Screening Visit which may need to take place over more than 1 day. Participants deemed eligible following their screening visits will be required to attend a single study visit that lasts for up to 8 hours. During this visit participants will be asked to complete at least 3 full body PET scans, which will include an injection of the study tracer and collection of blood samples at various timepoints. Participants may be asked to complete 1 additional scans and will then be followed up for 6 days, including general monitoring. It is hoped that this study will help determine if the study imaging agent is a safe and effective tracer that can be used in the imaging of tumours in individuals with cancer.

VEXAS (Vacuoles, E1 enzyme, X-linked, Autoinflammatory, Somatic) is a recently discovered rare disease (incidence less than 1 in 20,000 persons) characterized by severe inflammatory symptoms and no known effective treatment. Although the disease superficially appears similar to typical autoimmune rheumatological diseases, emerging research suggests that it is driven by proinflammatory monocytes that are produced in the bone marrow by the cytokine granulocytemacrophage colony stimulating factor (GM-CSF). Patients are often misdiagnosed and there are no effective therapies and at least half of VEXAS patients also suffer with myelodysplastic syndrome, according to our local VEXAS Registry. Our preliminary studies suggest that the combination of azacitidine and Lenzilumab can be effective in reducing progenitor cells. Secondly, ongoing clinical trial of CMML (ACTRN12621000223831) this combination is found to be safe and effective. We will conduct a pilot study to assess the feasibility of Lenzilumab with azacitidine as a potential life-saving treatment for VEXAS

This study is to determine the efficacy of use of single use Negative Pressure Wound Therapy products in the community at varying pressures to determine which device would effectively heal patient wounds more rapidly and that is comfortable and easy to apply.

Hyperkalaemia is a potentially life-threatening condition caused by high blood potassium levels. It is commonly treated with insulin and glucose, but insulin can lower blood sugar too much, leading to hypoglycaemia—a condition that can cause confusion, shakiness, or even loss of consciousness. We want to find out whether glucose alone, without insulin, can safely and effectively lower potassium levels in people without diabetes. This may be possible because glucose stimulates the body to produce its own insulin. We are conducting a clinical trial at the Royal Brisbane and Women’s Hospital Emergency and Trauma Centre to compare standard insulin–glucose therapy with glucose-only treatment. The trial will assess both safety (risk of hypoglycaemia) and effectiveness (potassium reduction). If glucose-only therapy is found to be safer and just as effective, it could change the standard treatment for hyperkalaemia.