Posted 17.08.17 by admin
The goal of this study is to carefully look at the compounds someone exhales to determine if analysis of exhaled breath can detect lung cancer. This test is not invasive and easy to perform. It would therefore be a good tool for screening of people at risk for the development of lung cancer, such as smokers. Ultimately we hope this study will help to prove that analysis of exhaled breath allows early detection of lung cancer. This would help to treat disease earlier and improve the outcome.
No, taking part in this study is entirely voluntary. If you think that you would like to take part, we will go through this information sheet with you to make sure that you understand why we are doing this study. We will discuss what would be involved if you decide to take part. You will be able to ask any questions that you may have. It is then up to you to decide. If you would like to take part, you will be asked to sign a consent form to show that you have agreed to this. You will be given a copy of the consent form and this information sheet to keep. If you do not want to take part at any time, even after signing the consent, you do not have to give a reason. Your care will not be affected by this decision.
If you participate in the study we will ask you to perform a breathing test. For this test you will be asked to breathe normally into a facemask for 7-12 minutes. You will not notice any interruption of your normal breathing pattern when wearing the mask. You will inhale clean filtered room air to make sure background compounds that circle around the room don’t change the signal. Your breath will be stored in 4 small tubes that will be sent for further analysis. During the procedure a nurse will be monitoring your breathing and whether you are comfortable. If you do feel uncomfortable during the procedure you are free to interrupt it and consider continuing afterwards. You will be able to remove the facemask yourself or the nurse will assist you.
Clinical and background data
Besides collecting a breath sample, it is important to gather some clinical and background data. You will be asked some simple questions about your past medical history, your smoking history and whether you or any of your close family members have ever had cancer or lung disease. Additionally, some questions relevant for the breath measurement, such as your eating pattern, will be asked. This information will be collected around the time of the breath test and it should not take more than 20 minutes of your time.
Every effort will be taken to minimize your effort for this study. Your treating physician will inform you about all procedures necessary for your diagnostic test. Your participation in this study also means that data from these tests that are in your medical notes will be used for this research project. This is important because it helps us to link the compounds in the breath to your health status and determine if the test works.
The risk to you, as a result of taking part in this study, is very small. The collection of breath does not interfere with your normal breathing pattern. During the procedure you will only inhale clean room air without any additives. A nurse will monitor your breathing during the procedure to make sure you are well. If you do feel uncomfortable, you or the nurse can interrupt or abort the measurement.
You will not directly benefit from taking part in this research. We hope that the information that we obtain by analyzing your breath can be used to diagnose lung cancer at an earlier stage in the future. This will help to benefit future patients like you can benefit from previous research now.
All the information that is collected about you for this research will be kept strictly confidential. Information about you will be stored securely in accordance with the Data Protection Act (1998). Any information that is collected about you as a result of taking part in this research will be given a code number to replace your name and address so that you cannot be identified. Occasionally, local NHS Research & Development staff may need access to your medical records. This is to check that the research is being carried out according to national guidelines and to monitor how many people have agreed to take part. Individuals monitoring for this purpose will be suitably qualified and will not disclose any personal information about you. If you agree on the consent form we will inform your general practitioner about your participation in this study.
The samples that you give will be sent for analysis to Owlstone Medical Ltd. By this stage all samples will be anonymized. Therefore no one outside the hospital will be able to match your sample or the resulting data to you as an individual.
No genetic tests will be done in this study.
Scientists at Owlstone Medical Ltd will analyze the results of this study. It is anticipated that the results will be published in scientific journals. You will not be identified in any of these reports or publications. If you would like to have a copy of any report or publication arising from this study please let your doctor or research nurse know. After completion, the data that specifies the compounds identified in the sample will be incorporated into an algorithm that helps to identify compounds related to lung cancer in the breath in future patients. Similarly this data may be used in future ethically approved research projects. This data can’t be linked to you as a person.
If you would like any further information about this study or have any questions, please contact:
Dr Elizabeth Fuller, Principle Investigator
Judith Moore, Clinical Trials Officer (0191) 404 1000 Ex 2263
Customer Services, (0191) 404 1072
Thank-you for taking time to read this information and for considering participation in this study.
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Posted 17.08.17 by admin
Posted 17.08.17 by admin
Posted 10.07.17 by admin