ANZCTR search results

Circulating Tumour DNA as a marker of complete athological response and long term outcome for locally advanced rectal cancer treated with pre-operative chemoradiotherapy. The aim of the study is to demonstrate that the eradication of ctDNA in peripheral blood following completion of pre-operative chemoradiotherapy (CRT) is a sensitive and specific predictor of complete pathological response (pCR) in locally advanced rectal cancer

The purpose of this study is to measure cancer specific gene changes in the blood as a biomarker in monitoring disease status in stage II and IV colorectal cancer. Biomarkers are substances that can be found in blood and/or tumour tissue and may be used to measure the effects or progress of a disease or condition. Genes are substances in the body which contain information about characteristics us as individuals. Previous studies have found that the majority of colorectal cancers contain mutations in several genes (the gene is changed or different from the common form) and that these cancerrelated mutations can be detected in the blood. Identifying biomarkers are important because: they may be linked with disease progression, they may help to identify people who are most likely to benefit from a certain treatment such as chemotherapy, or they may be used to track the status of cancer without the need for invasive procedures, such as biopsies.

The effectiveness of treatment to reduce heart disease risk can vary a great deal between individuals. this is partly due to an individuals genetic makeup. Fatty acid metabolites called CYP450metabolites of arachidonic acid can act on blood vessels and the kidney to regulate blood pressure. one of these metabolites known as 20-HETE is known to be affected by dietary salt intake. we will study volunteers with two different genetic make-ups that affect 20-HETE levels differently to see if they affect blood pressure and heart disease risk. We will asses whether having either genetic make up causes a blood pressure and plasma and urinary 20-HETE when participants have different intakes of dietary salt.

This project will investigate the effect of pasta incorporating red and white sorghum flours on hunger, blood glucose and other blood measurements related to health.

This is a Phase II clinical trial for the study of the efficacy of Lariam (Mefloquine) antimalarial drugs against Plasmodium falciparum by experimental challenge with a low dose of blood stage parasites in healthy adult volunteers. This trial is to be conducted under the Australian Therapeutic Goods Administration (TGA) Clinical Trial Notification Scheme(CTN). The purpose of the study is to characterize the pharmacokinetic-pharmacodynamic relationship of mefloquine on clearance of Plasmodium falciparum parasites from the blood in healthy volunteers following infection with blood stage parasites, to characterize the pharmacokinetics and the relationship between mefloquine pharmacokinetics and parasite kinetics in healthy volunteers following infection with blood stage Plasmodium falciparum.

Foot pain is highly prevalent in older people, and in many cases is associated with wearing inadequate footwear. In Australia, the Department of Veterans’ Affairs (DVA) covers the costs of medical grade footwear for veterans who have severe foot deformity. However, there is a high demand for footwear by veterans with foot pain who do not meet this eligibility criterion. Therefore, the purpose of this randomised controlled trial is to evaluate the effectiveness of low cost, off-the-shelf footwear in reducing foot pain in DVA recipients who are currently not eligible for medical grade footwear. One hundred and twenty DVA clients with foot pain residing in the northern suburbs of Melbourne, Australia, who are not eligible for medical grade footwear will be recruited from the DVA database, and will be randomly allocated to an intervention group or a “usual care” control group. The intervention group will continue to receive their usual DVA-subsidised podiatry care in addition to being provided with low-cost, supportive footwear (Dr Comfort [registered trademark]) fitted by a podiatrist. The control group will also continue to receive DVA-subsidised podiatry care, but will not be provided with the footwear until the completion of the study. The primary outcome measure will be pain subscale on the Foot Health Status Questionnaire (FHSQ), measured at baseline and 4, 8, 12 and 16 weeks. Secondary outcome measures measured at baseline and 16 weeks will include the function subscale of the FHSQ, the Manchester Foot Pain and Disability Index, the number of DVA podiatry treatments required during the study period, general health-related quality of life (using the Short Form 12), the number of falls experienced during the follow-up period, the Timed Up and Go Test, the presence of hyperkeratotic lesions (corns and calluses), the number of participants using co-interventions to relieve foot pain, and participants’ perception of overall treatment effect.

Major depressive disorder is a severe illness of high prevalence. A significant percentage of patients fail to respond to standard treatments and continue to experience marked disability and high morbidity. Repetitive transcranial magnetic stimulation (rTMS), which is a non-invasive means of stimulating nerve cells in superficial areas of the brain, is a promising therapy for those with treatment-resistant depression. Previous research conducted by our group clearly indicates that rTMS has antidepressant activity and that the response to rTMS is clinically meaningful in some patients. Whilst several forms of rTMS are clearly effective, no one type of rTMS has demonstrated markedly greater responses that other approaches. In recent years interest has developed into whether the dose of rTMS, in particular the number of pulses applied, is related to response to treatment (the percentage of patients that respond to treatment, the ‘response rate’). However, as there is a considerable time cost to higher dose protocols, their usefulness requires systematic evaluation. Therefore, the primary goal of this study is to examine whether response to rTMS is greater or more rapid when treatment is applied at a higher dose. To do this we will compare standard and high dose strategies for both low frequency rTMS applied to the right prefrontal cortex, and high frequency rTMS applied to the left prefrontal cortex. A secondary goal of the study is to explore potential predictors of antidepressant response to rTMS using brain imaging analysis.

This is a phase 2 bilateral (both sides of the face), comparison study to assess two formulations of ELAPR (Tropoelastin) compared to Juvederm (Registered Trademark) Ultra Plus for the treatment of moderate to severe Nasolabial folds. Patients presenting to the clinic for treatment of moderate to severe Nasolabial folds will be recruited to the study. Following a screening period of up to 28 days, patients who meet the entry requirements and none of the exclusion criteria will be randomized to receive treatment with one of two ELAPR (Tropoelastin) formulations. Patients will attend the nominated sites for all procedures and be treated by the study investigator. Patients will receive either ELAPR002b (Tropoelastin) or ELAPR002d (Tropoelastin) for the treatment of one NLF, and Juvederm (Registered Trademark) Ultra Plus for the treatment of the second, opposite Nasolabial fold. Treatments will be provided on Day 1 and repeated on Day 29 (if required) and Day 57 (if required). Each treatment will consist of up 15 injections in total, each consisting of up to 0.1 ml of product, at the discretion of the treating consultant delivered to the mid to deep dermis of the skin of each Nasolabial fold using a 27G needle. The needle will be inserted at an approximate angle of 30 degrees parallel to the skin, and the product may be injected by a retrograde injection or by deposition of a bolus. ELAPR (Tropoelastin) and the control may be implanted parallel or perpendicular to the Nasolabial fold. Exactly the same technique will be used for the treatment of both Nasolabial folds for each patient. When the injection is completed the treated Nasolabial fold may be gently massaged if required to enable the implant material to conform to the contour of the surrounding tissues. Following the treatment of the Nasolabial folds, each patient will then have the same preparations (ELAPR002b or ELAPR002d, and Juvederm (Registered Trademark) Ultra Plus implanted as a 0.1ml bolus into the mid-deep dermis of the skin of the medial aspect of the upper arm (left or right arm) using a 27G needle on Day 1. The arm chosen by the patient will receive two implants, approximately 20mm apart, proximal being the ELAPR (Tropoelastin) (according to randomisation) and distal being Juvederm (Registered Trademark) Ultra Plus. The centre of the implants (on the upper arms) will be marked with a needle point tattoo. The tattoo mark will assist in locating the implant sites. Patients will have safety observations for 60 minutes after each treatment. Photographs of the patient's Nasolabial Folds and the upper arm implants will be taken before and after treatment and at each follow-up visit for record keeping purposes only. The two 2mm skin biopsies will be collect at the same visit at Day 57, Day 85 or Day 169 according to randomization from the upper arm implant sites. The 2mm skin biopsies will encompass the needle point tattoo at the centre of the implant site. The biopsy wounds will be allowed to heal by secondary intention wound healing, under a non-stick or waterproof dressing. All Patients will return on Day 8, 29, (36), 57, (64) 85 and 169 for evaluation. If there is no further treatment at Day 29 to achieve OCR, then the Day 36 visit is omitted. If there is no further treatment at Day 57 to achieve OCR, then the Day 64 visit is omitted. Patients will have both upper arm biopsies scheduled for the same visit on Day 57, Day 85 or Day 169. At each visit, patients will be asked questions related to the status of the Nasolabial fold and upper arm implants, skin site texture, skin reactions and any activities undertaken which may impact on the implants. The physical presence of the Nasolabial fold implants will be assessed by the investigator at each visit. To assess the effects of ELAPR (Tropoelastin) and Juvederm (Registered Trademark) Ultra Plus subjective feedback on the comfort and feel of the implant sites will be collected for the Nasolabial folds using a Visual Analogue Scale based questionnaire. Safety evaluations will consist of monitoring and recording of all spontaneously reported and observed adverse reactions to the study device, general physical examination and clinical laboratory safety testing. Extension Protocol An Extension protocol is being designed and will be submitted for approval prior to the first patient reaching the end of the current study. It will be designed to continue follow-up of those patients with persistent study device implant effects at the end of the current study period.

This is sub-study of another trial that is nearing completion. This trial has been registered on the ANZCTR: ACTRN12611001228976, Title: Impact of an Integrated Point of Care Testing service for patients presenting to the Emergency Department on time to disposition decision: a randomised trial. In this trial appropriate patients presenting to the emergency department were randomised to have blood tests performed either by a point of care device or by the central laboratory. There were two main groups that were enrolled: patients with suspected acute coronary syndrome, and a general group of patients who only needed blood tests from the limited selection available by point of care. Randomisation was stratified according to these two groups. The primary outcome of this trial was time to admission/discharge decision. This sub-study involves only those patients suspected of an acute coronary syndrome, and following them up at 3 months for clinical outcomes. The purpose of this study is to demonstrate that performing troponin testing using a point of care device in the emergency department and operated by emergency staff will produce the same clinical outcomes at 3 months amongst patients suspected of having an acute coronary syndrome.

Depression is very common in people with vision impairment and can lead to heightened levels of disability and functional decline. However only a minority of people with vision impairment gain access to psychological support services. Together with Vision Australia and beyondblue we will examine the impact of different depression management options for people with vision loss.