RESPIRATORY ANCILLARY STUDY (RAS) AS A SUBSTUDY OF SELECT TRIAL

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The SELECT (IRB# 010049-01) is a multicenter randomized prospective clinical trial to assess the effect of Selenium and Vitamin E alone and in combination on the clinical incidence of prostate cancer. The RAS (IRB# 11798-01) is an ancillary study to SELECT, thus it is carried out completely within the SELECT structure. The RAS achieves its aims through collecting some additional medical information on a subset of SELECT participants. The RAS study sites are the 18 SELECT study sites. The RAS will target all participants or some of the participants, depending on the SELECT site. RAS participants must be an active SELECT participant and on Supplements at the time of registration to RAS. The overall objective of the RAS is to understand whether supplemental antioxidants can slow the loss of lung function that occurs naturally with aging. This is particularly important for smokers, who have a more rapid loss of pulmonary function with increasing age. Informed consent and PHI authorization from potential participants is a requirement prior to registration to RAS at their initial visit. All RAS participants will be followed for four years and three spirometry tests and one time blood sample collection (at the SELECT third annual visit) will be done during this period. The risk for RAS participants is minimal. Eligibility for spirometry will be tested at each visit to make sure it is safe for participants to perform the pulmonary function test. The risk of infection from the spirometry test is very minimal, because the mouth pieces are disposable and the gloves and proper hand washing techniques are used by the staff. The risk of fainting from spirometry is also minimized, because the test is done while sitting in a chair. A blood drawing could cause minor discomfort and/or leave a temporary bruise. Blood sample will be collected by a trained nursing staff, which should minimize likely complications of venopuncture. In collaboration with the SELECT statistical center, the RAS staff will coordinate the administration, data management and the RAS coordinator center will conduct data review and statistic analysis.