None listed
Conditions
Brief summary
This study aims to determine whether a blood test can be used to detect prostate, breast, lung, pancreas, oesophageal, stomach and digestive tract cancers. Who is it for? You may be eligible to join this study if you are male or female aged 25 years or older and have a known diagnosis of primary adenocarcinoma of the prostate, breast, lung, pancreas, oesophagus, stomach or a digestive tract cancer (of any pathological stage). You must also be willing to undergo a venepuncture procedure. Study details All participants in this study will have blood collected through venepuncture (i.e. directly from the vein) by trained nurses prior to any type of cancer treatment. A blood sample will be collected before any cancer treatment to measure circulating tumour DNA (ctDNA) markers. In addition, for participants with oesophageal or stomach cancer, follow-up blood samples will then be taken at two monthly intervals up to six months during chemotherapy treatment, and at six monthly intervals up to three years after treatment, to monitor the effect of treatment on the different cancer types. For patients that undergo cancer resection prior to chemotherapy or radiotherapy, consent will be asked to obtain some tissue samples from any excess specimen from surgery. Blood and tissue samples will then be analysed for specific biomarkers of interest. Other information about the cancer (e.g. stage of disease), current medications, and other medical conditions will also be collected. Our research may lead to the development of improved non-invasive diagnostic tests for the detection of adenocarcinomas, including prostate, breast, lung, pancreas, oesophageal, stomach and digestive tract cancers. This would have beneficial health outcomes as early detection can contribute to early intervention and better prognosis. This test may also be beneficial in monitoring the effectiveness of cancer treatment in certain cancer types.
Interventions
Removal of all reference to the Repatriation General Hospital and inclusion of the Noarlunga Health Service.
Patients diagnosed with a primary adenocarcinoma of the lung, pancreas, oesophagus or stomach (n=250 per diagnosis), or one of the more rare types of digestive tract cancers, such as, gallbladder, biliary tract, duodenal and periampullary (n=25 per diagnosis) who attend clinic appointments at Flinders Medical Centre, Noarlunga Health Service, the Queen Elizabeth Hospital, the Royal Adela
Removal of all reference to the Repatriation General Hospital and inclusion of the Noarlunga Health Service. Patients diagnosed with a primary adenocarcinoma of the lung, pancreas, oesophagus or stomach (n=250 per diagnosis), or one of the more rare types of digestive tract cancers, such as, gallbladder, biliary tract, duodenal and periampullary (n=25 per diagnosis) who attend clinic appointments at Flinders Medical Centre, Noarlunga Health Service, the Queen Elizabeth Hospital, the Royal Adelaide Hospital and Lyell McEwin Hospital will be enrolled into the study after obtaining informed consent. Blood will be collected through venepuncture (3 x 9mL K3-EDTA tubes and 1 x 8mL serum clot activator tube) by trained nurses prior to any type of cancer treatment (ie. prior to chemotherapy, radiotherapy and surgery). Whole blood samples will be centrifuged, and plasma and serum will be isolated and stored in cryovial aliquots at -80 degrees until analysis for concentrations of methylated BCAT1 and IKZF1 and other novel biomarkers. For patients that undergo cancer resection prior to chemotherapy or radiotherapy, consent will be asked to obtain some tissue samples from any excess specimen from surgery or biopsy (a cancer specimen and adjacent normal tissue). The collection of this tissue will be stored in the Flinders Medical Centre tissue bank. Tissue will have DNA extracted for analysis of biomarker levels to allow direct comparison to blood biomarker levels within the same patient. Cancer pathology details (including stage of disease, pathological features, and Gleason Score for prostate cancer) will be recorded. Other blood indicators that have been taken as part of clinical care prior to surgery (such as PSA for prostate cancer) will be recorded. Patients will be interviewed by nurses to record current medications and other medical conditions, as well as any previous cancers. Levels of methylated BCAT1 and IKZF1 in the blood and surgical tissue will be determined for each cancer type and stage. Genomic material (DNA or RNA) will be extracted from blood and/or tissue samples for genetic sequencing analysis to uncover genomic locations that are associated with the patient’s tumour, that are commonly found in adenocarcinomas.
Sponsors
Erin Symonds
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
25 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-Male or female aged 25 years or more -Known diagnosis of primary adenocarcinoma of the prostate, breast, lung, pancreas, oesophagus, stomach or digestive tract cancers (of any pathological stage) -Ability and willingness to undergo venepuncture procedure -Patients must be capable of providing satisfactory informed consent
Exclusion criteria
-Unable to provide informed consent.
Outcome results
None listed