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

呼吸辅助研究 (RAS) 作为选择性试验的子研究

• 批准号: 7606206
• 负责人: ROWAN T. CHLEBOWSKI
• 金额: $ 6.16万
• 依托单位: LUNDQUIST INSTITUTE FOR BIOMEDICAL INNOVATION AT HARBOR-UCLA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-02-01 至 2007-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606206
• 关键词: Age; Aging; Ancillary Study; Antioxidants; Authorization documentation; Blood; Blood specimen; Clinical; Clinical Trials; Collaborations; Computer Retrieval of Information on Scientific Projects Database; Contusions; Data; Eligibility Determination; Funding; Grant; Handwashing; Incidence; Infection; Informed Consent; Institution; Left; Malignant neoplasm of prostate; Medical; Minor; Nursing Staff; Oral cavity; Participant; Pulmonary function tests; Randomized; Research; Research Personnel; Resources; Respiratory physiology; Risk; Selenium/vitamin E; Site; Smoker; Source; Spirometry; Structure; Syncope; Techniques; Testing; Time; Training; United States National Institutes of Health; Visit; data management; prospective; pulmonary function; respiratory; sample collection; statistical center; statistics

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.

这个子项目是许多利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得了主要资金， 因此可以在其他CRISP条目中表示。所列机构为 研究中心，而研究中心不一定是研究者所在的机构。 SELECT（IRB# 010049-01）是一项多中心随机前瞻性临床试验，旨在评估硒和维生素E单独使用和联合使用对前列腺癌临床发生率的影响。 RAS（IRB# 11798-01）是SELECT的辅助研究，因此完全在SELECT结构内进行。RAS通过收集SELECT参与者子集的一些额外医疗信息来实现其目标。RAS研究中心为18家SELECT研究中心。 RAS将针对所有参与者或部分参与者，具体取决于SELECT研究中心。RAS参与者必须是活跃的SELECT参与者，并且在注册RAS时正在服用补充剂。 RAS的总体目标是了解补充抗氧化剂是否可以减缓随着衰老自然发生的肺功能丧失。这对吸烟者尤其重要，他们随着年龄的增长肺功能丧失得更快。潜在受试者在首次访视时登记到RAS之前，需要获得知情同意书和PHI授权。所有RAS受试者将接受4年随访，在此期间将进行3次肺量测定检查和1次血液样本采集（在SELECT第3次年度访视时）。 RAS参与者的风险极小。将在每次访视时检测肺功能测定的合格性，以确保受试者进行肺功能检查是安全的。肺量测定法检测的感染风险非常小，因为口罩是一次性的，工作人员使用手套和适当的洗手技术。 由于肺量测定法是坐在椅子上进行的，因此也最大限度地降低了昏厥的风险。抽血可能会导致轻微不适和/或留下暂时性瘀伤。血液样本将由经过培训的护理人员采集，这应尽量减少静脉穿刺的可能并发症。 RAS工作人员将与SELECT统计中心合作，协调行政管理和数据管理，RAS协调中心将进行数据审查和统计分析。