ANZCTR search results

This is a proof-of-concept study and is not formally powered for hypothesis testing. This is an exploratory, proof-of-concept, open-label study conducted in three independent cohorts (creatine/creatinine, phenylalanine, and tryptophan). Participants will be assigned to a cohort at screening. Participants may be enrolled into any cohort in a non-sequential manner; enrolment is not restricted to a predefined order. This flexible approach allows for parallel recruitment across cohorts based on eligibility and operational readiness. The cohorts consist of: • Cohort 1 = Administration of Creatine for monitoring of Creatinine • Cohort 2= Administration and monitoring of Phenylalanine • Cohort 3 = Administration and monitoring of Tryptophan The primary objective is to evaluate the ability of TDM monitoring patches to detect and continuously track target analytes in interstitial fluid (ISF). Secondary objectives are to assess the relationship between patch-derived signal and blood analyte concentrations and to evaluate device-to-device reproducibility across multiple patches Approximately 12 participants per cohort will be enrolled, with a total sample size of approximately 36 participants across the three cohorts. The sample size is considered sufficient to assess feasibility, signal detection, and variability.

This is Part 1 of a 2-part study to evaluate the safety, tolerability and efficacy of TO-O-1007 IVT implantation in the eye of participants with Geographic Atrophy (GA) secondary to age-related macular degeneration (AMD). Part 1 of the study will test if it is safe to implant a low dose and then a higher dose of TO-O-1007 IVT in the eye of people with GA which is an advanced form of AMD and explore the effectiveness of the implant on GA progression. Age-related macular degeneration (AMD) is a disease of the macula, an area in the retina found at the back of the eye, needed for sharp, clear vision and activities such as reading and sewing. The advanced form of dry AMD is known as geographic atrophy (GA) (a region of the retina where the cells wither away and die). Sometimes, these regions of GA look like a map to the doctor who is examining the retina, hence the term “geographic atrophy.”

Brief description of the study purpose This is a first in human exploratory imaging study testing two new radioactive imaging agents designed to detect cancers that express a marker called the gastrin releasing peptide receptor (GRPR) in people with advanced or metastatic breast or prostate cancer. The study aims to assess safety, how the agents distribute in the body, radiation dose to organs and tumours, and how well they image cancer lesions. Who is it for? You may be eligible for this study if you are male or female aged 18 years or older with advanced or metastatic breast or prostate cancer that has continued to progress despite standard treatments, who are well enough to take part in imaging scans. Study details Participants will receive one injection of a radioactive imaging tracer followed by multiple PET/CT scans on the same day. If their cancer shows uptake of the tracer, they may also receive a second, very low dose radioactive medicine followed by several SPECT/CT scans over the following days. Blood tests, vital signs checks, ECGs, and medical monitoring will be performed before and after the injections. The results from this study will help guide the future development of a GRPR targeted imaging and treatment approach, with the potential to improve how breast and prostate cancers are identified and treated in the future.

This study investigates how adults with metabolic syndrome respond to fibre-enriched meals. Participants will attend a clinic visit where standardised test meals will be consumed, followed by a home monitoring period. Blood samples and continuous glucose monitoring will be used to assess postprandial metabolic responses, including glucose and triglycerides. Additional data on diet, physical activity, and other individual characteristics will also be collected. The study aims to understand individual variability in metabolic responses to dietary fibre and to support the development of more personalised nutrition strategies.

Peripheral retinal ischaemia is strongly associated with the presence and severity of diabetic macular oedema (DMO), and ultra-widefield fluorescein angiography (UWF-FA) has demonstrated that peripheral non-perfusion is a key feature in eyes at risk of vision loss. Previous work (Hein et al., 2023) found that intravitreal aflibercept 2mg did not reverse or prevent progression of capillary non-perfusion in eyes with DMO. High-dose intravitreal aflibercept 8 mg has recently been approved and funded (TGA-approved and PBS-listed) for treatment of DMO, and is now used as standard-of-care in appropriate patients at our centre. Clinical trial and real-world data indicate that aflibercept 8 mg provides robust efficacy with a safety profile comparable to aflibercept 2 mg in DMO, with the potential to improve disease control and reduce treatment burden through extended dosing intervals. Given the greater pharmacodynamic effect of the 8 mg dose, it is plausible that aflibercept 8 mg may attenuate the natural course of retinal ischaemia progression in patients receiving treatment for DMO; however, its impact on retinal non-perfusion has not yet been systematically characterised.

This study will investigate whether vaginal probiotic supplementation (Amelia V-Spot) improves pregnancy outcomes in women undergoing frozen embryo transfer (FET) treatment as part of in-vitro fertilisation (IVF). Women under 45 years of age with a genetically tested normal (euploid) embryo undergoing FET will be randomly assigned to receive either a vaginal probiotic or placebo treatment. The main objective is to determine whether vaginal probiotics improve clinical pregnancy rates with FET. Secondary outcomes include ongoing pregnancy rates, miscarriage rates, live birth outcomes, changes in the vaginal microbiome, and any treatment-related side effects. The study will be conducted at an IVF centre in Sydney, Australia, with industry funding from Amelia Bio.

This single-site pilot will assess the implementation of a digitally enabled care model for adults with type 2 diabetes delivered through the Brisbane South Community Diabetes Service (BSCDS), Metro South Health. Participants will use a Bluetooth-enabled glucose meter with the Health2Sync app to upload glucose readings for clinician review in a secure dashboard. The model supports timely follow-up, workflow integration and patient self-management. Outcomes focus on feasibility, acceptability and workflow impacts, particularly in a population with higher socioeconomic disadvantage and culturally and linguistically diverse representation.

The Skin UNCUTstudy aims to investigate the utility and cost-effectiveness of confocal microscopy in the diagnosis of skin cancer Who is it for? You may be eligible to join this study if you are aged 18 years or above and have a skin lesion identified as a potential skin cancer that requires further diagnostic tests. Study details All participants in this study will undergo a cutaneous confocal microscopy (CM). CM is used to examine the first and second layers of skin to check for abnormal or cancerous cells. It is placed on the skin and is painless. This technique allows your doctor to see a detailed, magnified view of your skin cells, without the need to surgically remove a sample for investigation. Participants will then be randomly allocated (by chance) to one of two groups: one group will be allocated CM review by expert confocalists within 2-7 days of CM where they will receive either a CM recommendation of biopsy indicated or no biopsy indicated. Biopsy will be performed according to national guidelines, depending on lesion characteristics and site PI's (Principal Investigator) discretion as per standard of care. The other group will be allocated no CM review and provision of standard care with surgical biopsy according to clinical guidelines and clinical discretion of their treating physician/site PI. Diagnostic accuracy outcomes, economic impact of CM, patient acceptability and satisfaction are assessed up to 12 months post-randomisation. At the moment, standard care for skin cancer diagnosis is a physical examination of the skin via a surface microscope followed a surgical biopsy. This study aims to evaluate if CM can reduce the need for surgical biopsy. It is hoped that the results from this study determine whether CM can reduce unnecessary skin biopsies and their associated patient burden and healthcare costs and to produce evidence that more precisely characterises presence of malignancy, enabling more confident and appropriate clinical management.

Brief description of the study purpose: This pilot study aims to evaluate how effective and well tolerated combined ginger and vitamin B6 supplementation is in preventing or reducing chemotherapy induced nausea and vomiting (CINV) in adults receiving moderate to high emetogenic risk chemotherapy. Who is it for? You may be eligible for this study if you are male or female aged 18 years or older with a cancer diagnosis who are starting moderate to high emetogenic risk chemotherapy and experience nausea and/or vomiting during their first chemotherapy cycle. Study details Participants will first be observed during their initial chemotherapy cycle without ginger or vitamin B6. Those who experience nausea or vomiting will then receive ginger and vitamin B6 supplements alongside standard anti-emetic treatment from cycle 2 onwards, for up to 12 chemotherapy cycles if tolerated. All participants who enter the intervention phase will receive the study supplements; there is no randomisation or element of chance. Outcomes will be measured using patient reported surveys and the MASCC Antiemesis Tool to compare nausea and vomiting before and after the intervention. It is hoped this research will help clarify whether combined use of both ginger and vitamin B6 can be useful, well tolerated supportive options to improve nausea and vomiting control and overall quality of life for patients undergoing chemotherapy.

Brief description of the study purpose: This study aims to assess whether acupuncture is a practical, safe, and effective way to prevent nerve damage ( called chemotherapy induced peripheral neuropathy (CIPN)) in people receiving chemotherapy for early stage colorectal cancer. Who is it for? You may be eligible for this study if you are aged 18 years or older, have been diagnosed with early-stage colorectal cancer who have undergone surgery for the removal of colon cancer, and are planning to receive mFOLFOX chemotherapy, which can cause nerve damage (CIPN). Study details: This study is a randomized controlled trial at Northern Health Hospital in Melbourne. Participants will be randomly allocated to one of two groups in the trial: Acupuncture group: standard chemotherapy plus weekly acupuncture for 24 weeks. Each acupuncture session will last about 30 -45minutes (manual acupuncture or electroacupuncture). Needle retention time is 30 minutes. Participants will be monitored for nerve related symptoms from before starting chemotherapy until 28 weeks, using assessment and tests, which may include questionnaires and clinical evaluations. Another group: controlled group (standard care) with only mFOLFOX-6 chemotherapy, will be monitored and tested for symptom development from prior to chemotherapy to 28 weeks. After 24 weeks, participants in both groups may choose to receive acupuncture sessions voluntarily until week36. 15 participants of 30 participants and 6 health practitioners will be invited to be interviewed for sub-study face to face/online. The results of this research may help to shape future clinical guidelines for managing CIPN and cancer-related nerve pain in Australia and internationally, and improve supportive care for people undergoing chemotherapy.