ANZCTR search results

This study aims to find a simple and reliable way to identify which patients with rectal bleeding need an urgent colonoscopy. Rectal bleeding can be caused by bowel cancer or other conditions like haemorrhoids, and delays in diagnosis can occur because the symptom is not specific to cancer. Who is it for? You may be eligible for this study if you are aged 18 years and over who have been referred by their GP for rectal bleeding and are on a waiting list for an outpatient clinic appointment. Study details Participants who are eligible will be asked to complete 2 tests: A two-sample home stool test (similar to the one used in the national bowel cancer screening program). A blood test that looks for cancer-related changes in DNA. Participants will collect two stool samples at home and attend a study site for a blood sample. The stool sample will be tested for haemoglobin, and the blood sample will be tested for DNA methylation changes. All participants will also complete short health and wellbeing questionnaires at the time of testing and after their colonoscopy. If either test is positive, the participant will be offered an earlier colonoscopy. If both tests are negative, they will remain on the usual waiting list (standard care). This research hopes to improve how patients with rectal bleeding are prioritised for colonoscopy, helping to detect bowel cancer earlier and reduce waiting times for those at higher risk.

This study aims to evaluate a new fully automated insulin delivery system, the Novel Medtronic Experimental Automated Insulin Delivery System, NMX7-AID, which adjusts insulin based on continuous glucose monitoring with minimal user input. Unlike the current MiniMed™ 780G system, the NMX7-AID aims to eliminate the need for users to deliver meal-time boluses. In this study we will test the safety and performance of the NMX7-AID system in real-life situations, including physical activity. This trial will enrol 24 adults with type 1 diabetes to use the system under a standardised protocol. As part of the study, participants will complete eight exercise sessions of varying intensity to test how the system responds during and post-exercise .

INNA-051 is being developed to prevent or minimise illness from viral respiratory infections like the common cold, flu or COVID-19. The study is being performed in adults aged 18 to 45 years inclusive to assess the safety, tolerability and effects of INNA-051 dry powder administered intranasally by two systems (single use and multi-use) on Day 1 and Day 8 differing by treatment sequence in cohort 1 and cohort 2, and to understand participants’ experiences with each.

This study aims to examine the impact of hypofractionated radiotherapy (HF-RT), which involves delivering radiotherapy over a more intensive schedule, in patients with newly diagnosed Grade 4 glioblastoma. Who is it for? You may be eligible for this study if you are aged 18 to 70 years and have a newly diagnosed, histologically confirmed WHO (5th edition, 2021) Grade 4 GBM, IDH-wildtype, and have been placed on Stupp protocol for treatment. Study details Participants will be randomly allocated to either receive 4 weeks of hypofractionated radiotherapy (55 Gy in 20 daily fractions, 5 days per week), or 6 weeks of conventionally fractionated radiotherapy (60 Gy in 30 daily fractions, 5 days per week). Both arms will also receive concurrent and adjuvant temozolomide chemotherapy. Data on survival, health-related quality of life and healthcare resourcing will be collected from all patients. It is hoped that findings from this study will help provide valuable data to researchers on the utility of HF-RT in glioblastoma patients.

Menstrual pain (dysmenorrhoea) affects approximately 70-80% of physically active females and has been associated with reduced exercise performance, exercise participation and quality of life. Common treatments like painkillers (e.g., Panadol, Nurofen) and hormonal contraceptives, are often accompanied with side-effects and are not appropriate for all females. Emerging evidence suggests Omega-3, known for its heart and anti-inflammatory benefits, may also reduce menstrual pain, improve mood, support muscle recovery and improve endurance performance. However, research has yet to test Omega-3 in physically active females and whether the reduction in menstrual cycle symptoms can result in improved endurance performance. This study aims to test whether Omega-3 supplementation can reduce menstrual pain and improve 5km running performance. The study will also investigate the underlying mechanisms (such as changes in menstrual blood biomarkers) and other performance measures like heart rate recovery, running economy, and fuel use during exercise.

The purpose of this study is to assess if adding Lutetium-177 PSMA-597 radionuclide therapy (177Lu-PSMA) to Androgen Deprivation Therapy (ADT) and an Androgen Receptor Pathway Inhibitor (ARPI) will be more effective for treating men with prostate cancer that has spread and can be treated with hormone therapy. Who is it for? You may be eligible for this study if you are a male aged 18 or over who has prostate cancer that has spread to other parts of the body but it can be treated with hormone therapy. This means that male sex hormones, including androgens like testosterone, can be blocked or stopped to slow cancer growth. You must have evidence of metastatic disease on imaging, a reasonable general health status (ECOG 0-2), a life expectancy of at least 12 weeks, and adequate blood and organ function. Study details All participants will be receive ADT and an ARPI as you would normally get for treatment for this type of cancer, as well as an adaptive dosing of 177-Lu-PSMA. You will have PSMA PET/CT scans, blood tests, and other routine health checks to monitor your response and side effects. It is hoped that this study will help provide important information on whether adding adaptive dosing of 177Lu-PSMA to ADT and ARPI treatment will lead to better treatment responses.

Preventive care is a critical part of the Australian and NSW health system. A key component of preventive care is addressing modifiable risks such as smoking/vaping, poor nutrition, alcohol misuse, physical inactivity, and weight (SNAP-W). We will test if a digital tool (+ usual care) is a more effective way than usual care alone for people on a orthopaedic outpatient waiting list to receive preventive care over a 12 week period. We will use three primary outcomes: i) receipt of assessment for SNAP-W risks, ii) receipt of advice for relevant SNAP-W risks, and iii) receipt of a referral for at least one support service for relevant SNAP-W risks.

In this randomised, double-blind, placebo-controlled study, 150 non-anaemic women aged 18 to 50 years with blood ferritin levels below 30 µg/L and self-reported fatigue will be randomly assigned to receive 30mg of elemental iron from microencapsulated iron pyrophosphate or ferrous bisglycinate (in combination with 70mg of vitamin C), or a matching placebo for 12 weeks. Changes in self-reported fatigue, mood, brain fog, sleep quality, restless legs, and gastrointestinal symptoms will be assessed over time. Changes in cognitive performance, as assessed by computer-based tests, blood iron stores, complete blood count, heart rate variability, and body composition, will also be examined.

DCLC has been implemented overseas for a number of years with success in reducing costs without compromising patient quality. Uptake in Australia is still sporadic as traditionally patients scheduled for elective Laparoscopic Cholecystectomy (Lap Chole) at our institution and others are admitted on the same day of surgery and discharged the following day. In early 2023, Werribee Mercy Health implemented elective DCLC in attempt to increase efficiency, reduce burden on the public health system whilst not compromising on quality of patient care. A policy was designed for patient selection along with a detailed perioperative protocol. The aim of this study is to review the effectiveness DCLC at our institution in comparison with that in literature.

Retained placenta is a common complication following medical termination of pregnancy >13 weeks' or induction of labour for fetal demise, occurring in 19% of cases. The standard of care in our hospital is to administer intramuscular oxytocin 10IU with delivery of the fetus. A small randomised controlled trial compared use of intravenous carbetocin to oxytocin in this cohort and found a significant reduction in rate of placental retention, third stage blood loss and need for surgical curettage. We aim to randomise pregnant people >13 weeks' gestation who are undergoing medical termination or induction of labour for fetal demise to either intravenous carbetocin 100mcg or intramuscular oxytocin 10IU (standard of care) for third stage management. The primary outcome is reduction in incidence of placental retention. The secondary outcomes include total blood loss with delivery, duration of hospital stay, use of additional uterotonics, blood transfusion, high dependency unit admission, incidence of infection post delivery, need for further intervention for retained products of conception and cost effectiveness between the two groups.