Streamlining lung cancer diagnosis through genomic testing of cytology smears
Royal Brisbane and Womens Hospital
140 participants
May 31, 2018
Interventional
Conditions
Summary
The purpose of this study is to assess whether a new screening method is effective in providing a clearer picture of lung cancer. Who is it for? You may be eligible for this study if you are about to undergo endobronchial ultrasound guided transbronchial needle aspirate (EBUS-TBNA) in order to assess the presence of lung cancer. Study details There are 2 samples which will be used from patients- one is samples from the EBUS TBNA test and the other is a blood test. The EBUS TBNA test will still have the goal of making the diagnosis your doctor is aiming to obtain. This sample will also be used for determining the best way this needle test should be done and how the maximum information about the genes in a cancer can be obtained form this test. Very importantly this new method should significantly improve the samples to make them ideal for very rapid analysis to obtain the information about the all-important genes. We have done studies to use lung samples to simultaneously test 48 genes with one machine. We want to take this further in 2 ways- one is to streamline the best way of actually drawing out the tiny amounts of material from the node. For example we will compare moving the needle within the nodes 3 versus 10 times. The other is to send the sample to a different machine which can sample the entire range of genes in the cancer- not just 48. We want to see if this is possible to do with the tiny amounts of sample we will send to the machine - only a drop or 2 of node sample. The blood test will be used to compare your normal genes with gens of any cancer in the sample. This blood test will be taken at the time your cannula is placed and will not hurt. It is hoped that this research will help determine whether this testing provides a better picture of lung cancer to patients and thus further helps doctors determine how best to treat it.
Eligibility
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Interventions
Patients are those presenting for diagnosis of enlarged mediastinal or hilar lymph nodes where a tissue diagnosis of lung cancer is required by Endobronchial Ulrasound Transbronchial Needle aspiration (EBUS TBNA). Patient study involvement duration is just for the length of time required to take the TBNA samples ( 5-10 minutes) and for the blood test, at time of cannulation ( 1-2 minutes).All cases would have maximum number of 5 passes of the TBNA needle into the node as is usual practice. Main outcome measure is comparing DNA yield from samples taken with differing agitations of the needle within the lymph node. Study question would be whether once in the node there is the same amount of tumour after 3 agitations of the needle versus 10 agitations of the needle, while suction was applied to the needle. this will be measured by DNA content on Rapid-on-site-examination slides ( Diff Quik). All patients would have samples collected with both 3 agitations and 10 agitations measuring the amount of DNA for each of these spearately. Patients would still have a SINGLE cell block sample from ALL needle passes plus a PAP stained slide for conventional histology and immunohistochemistry.
Locations(5)
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ACTRN12618001293257