ANZCTR search results

This research is testing if telling a person their risk of melanoma based on either their clinical risk factors or their genetic risk factors influence their skin screening behaviours. Who is it for? You may be eligible for this study if you are a healthy adult aged between 51 and 75 years old (inclusive) at the time of informed consent with no history of invasive or in situ melanoma. You must have also previously participated QSkin Sun and Health Study. Study details Participants will be randomly allocated to either of the two intervention groups who will receive one of the personal melanoma risk scores along with general skin health education, or the control group who will not be given a risk score and will only receive general education. Data on their screening habits and behaviours will be followed up over a one-year period. It is hoped that findings from this study will help inform potential screening programs for melanoma.

G-DISCOTEQ is testing how well two cancer drugs (Gemcitabine and Docetaxel) work when they are given directly into the bladder at the same time. Who is it for? You may be eligible for this study if you are a male or female age 18 or above with either carcinoma in situ with or without papillary tumours or papillary tumours. Study details Participants will receive intravesical chemotherapy consisting of Gemcitabine (1 g) and Docetaxel (37.5 mg) combined in 50 mL of saline per instillation. Treatment begins with an induction phase of weekly instillations for six weeks, followed by a maintenance phase of monthly instillations for ten months. After the intervention, participants will undergo cystoscopy, cytology, and biopsy. Medical records will be reviewed to evaluate key outcomes, including complete response rate, recurrence-free survival, progression-free survival, cystectomy-free survival, cancer-specific survival, overall survival, and safety. Quality of life will also be assessed through patient-reported outcome measures. It is hoped that the results from this study will contribute to the field of non-muscle-invasive bladder cancer.

This study will evaluate the effect of a high-fat meal on the pharmacokinetics of a single oral dose of ACE-2223-1 in healthy adults. Participants will receive the solid formulation of ACE-2223-1 in a fasted state and after a standardized high-fat meal in a randomized, two-period crossover design. The study aims to determine how food intake alters the absorption, peak concentration, and overall exposure of ACE-2223-1. Up to 8 healthy male or female adults aged 18–65 years with a body mass index of 18–30 kg/m² will be enrolled. Safety, tolerability, and pharmacokinetics will be monitored throughout each intervention period.

This is a single ascending dose study of ACE-2223-1 in healthy adult participants. You may be eligible for this study if you are aged 18 to 65 years and have a body mass index greater than or equal to 18 kg/m² and less than or equal to 30 kg/m², without any clinically significant medical history. Part C will determine the relative bioavailability (RBA) of an ACE-2223-1 solid formulation compared with the liquid formulation used in Parts A and B. Participants will receive both formulations in a randomized sequence with a washout period between doses. This part of the study aims to determine whether the new solid formulation of ACE-2223-1 is absorbed into the body in a similar way to the liquid formulation. We expect that the solid formulation will have comparable levels in the blood as the liquid, indicating it can be used interchangeably.

This study aims to test whether ACE-2223-1 is safe and well tolerated when given as single or multiple oral doses to healthy adults, and to understand how the body absorbs and processes the drug at different dose levels. This is a Single and Multiple-Ascending Dose Study of ACE-2223-1 in Healthy Adult Participants. Who is it for? You may be eligible for this study if you are aged 18 to 65 years living and have a body mass index of greater than or equal to 18kg and less than or equal to 30kg without clinically significant (CS) medical history. Study details: Part A and Part B will consist of up to 6 cohorts of 8 healthy male or female adults, randomized 3:1 to receive ACE-2223-1 or placebo. Part B may be initiated after satisfactory review of safety and data from at least the first 3 cohorts in Part A.

This study investigates if the addition of a molecule, platelet derived growth factor (PDGF) produced by the body in the normal healing process of a tooth extraction socket will improve the amount of bone formed. At the time of extraction a bone graft will be placed in the socket with PDGF as the test and saline as the control. Six to eight weeks later the extraction site will have an implant placed. The dimensions of the jaw will be measured clinically and radiography at the time of extraction and implant placement. In addition a bone sample will be taken to analyse the amount of new bone formed.

Sepsis is a leading cause of death and disability in children globally accounting for over >3 million childhood deaths per year. Beta-lactam antibiotics are the most commonly used antibiotic to treat sepsis in children. Rather than giving a large dose of antibiotics intermittently, giving antibiotics over a longer time-period may improve outcomes, as seen in adult trials. To date, there is no high-grade evidence to support this practice in children. The BUILD trial is multicentre, multinational, open-label, type 1 adaptive hybrid effectiveness-implementation trial with an in-built pilot that will investigate if prolonged infusions of beta-lactam antibiotics increase survival for children with sepsis, while also checking safety and feasibility.

The purpose of this study is to see if the approach of using a blood test called a ‘liquid biopsy’ multiple times throughout the patient journey can improve the management of lung cancer by successfully guiding treatment. We will assess if it is possible to incorporate liquid biopsy into the routine care of Australians with lung cancer, including evaluating the clinical benefits to patients and the economic impact to the health system. Who is it for? You may be eligible for this study if you are aged 18 years or older, you have been diagnosed with advanced non-small cell lung cancer and you have received at least one previous targeted cancer treatment. Additional health checks may also be conducted by the study doctors to ensure you are able to take part in this study. Study details: All participants who choose to enroll in this study will be asked to provide a blood sample for molecular testing (liquid biopsy). The liquid biopsy test analyses fragments of DNA released from a person's cancer into their blood, known as circulating tumour DNA (ctDNA). This helps doctors to understand how a person's cancer has changed over time. The liquid biopsy results will be reviewed be reviewed by a board of experts. They will make treatment recommendations based on the liquid biopsy results. These will be provided to the participant's treating doctor, for discussion with the participant. Decisions for treatment are made by the participant and their treating doctor. Options may include a clinical research study, treatment(s) available through special access programs, and/or standard of care treatment that is routinely available. Participants will be asked to provide blood samples multiple times over a period of up to 4 years, including at study entry, each time a new treatment is started, and each time a treatment stops working. If a previous tissue sample is available or will be taken, e.g. during surgery, this may also be tested for new changes. Participants will also be asked to complete questionnaires throughout the study for up to 4 years after they enroll. It is hoped this research will determine whether adding liquid biopsy into the routine care of Australians with lung cancer is achievable, the economic costs and value of adding this procedure and to identify possible benefits to individuals with lung cancer by finding new targeted treatments for them.

To study the comparison of the PK profiles of single doses of ANY- 004 (Oral Tirzepatide 20 mg and 40 mg Tablet) of Anya Biopharm Inc., Taipei, Taiwan (T) with single dose of MOUNJARO (Tirzepatide) 2.5 mg Subcutaneous injection of Eli Lilly and Company, USA among healthy, adult male and/or females under fasting conditions. To monitor clinical status, adverse events and laboratory investigations and assess relative safety and tolerance of Tirzepatide formulations (Tablet and Subcutaneous injection) under fasting condition.

This study aims to improve access to prehabilitation (exercise, nutrition, and psychological support) before surgery, for people with cancer in regional and rural NSW. The goal is to help participants be physically and mentally fitter before surgery, which is known to reduce complications and improve recovery after surgery. Who is it for? You may be eligible for this study if you are a male or female aged 18 years and over who have been diagnosed with cancer within the past 12 months and are planning to undergo abdominal surgery that requires a hospital stay of more than one day. Study details Five hospitals will participate in the trial. All sites will begin by collecting participant baseline data. Each hospital will then be randomly assigned to change to the intervention at different time points. Participants in the intervention group will take part in a prehabilitation program for up to four weeks before their scheduled abdominal surgery, with a minimum of two weeks if time is limited. The program combines telehealth and in-person sessions and includes exercise guidance, nutrition education, and psychological support. Participants will be loaned a wearable activity tracker (Fitbit) to monitor physical activity and will complete assessments related to physical activity, nutrition, and wellbeing. It is hoped this research will support wider delivery of prehabilitation services in regional and rural areas, helping improve surgical recovery and health outcomes for people with cancer.