IGF::OT::IGF CENTRAL DATA COLLECTION CENTER (CDCC)QUESTIONNAIRE AND BUCCAL CELL PROJECT. PERIOD OF PERFORMANCE: 09/19/2016 TO 09/18/2019

IGF::OT::IGF 中央数据收集中心 (CDCC) 问卷和颊细胞项目。

• 批准号: 9369389
• 负责人: SUNITHA MATHEW
• 金额: $ 93.08万
• 依托单位: WESTAT, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-19 至 2019-09-18
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9369389
• 关键词: Affect; Award; Biological; Cancer Control; Cells; Cessation of life; Colorectal; Consent; Consent Forms; Contractor; Contracts; Data; Data Collection; Databases; Division of Cancer Prevention; Future; Healthcare; Laboratories; Lung; Malignant Neoplasms; Medical History; Medicare/Medicaid; NCI Executive Committee; Ovarian; Participant; Performance; Phase; Process; Professional counselor; Prostate; Prostate, Lung, Colorectal, and Ovarian Cancer Screening Trial; Questionnaires; Research; Resources; Risk Factors; Site; Specimen; Time; Translating; Update; cancer risk; follow-up; genetic analysis; indexing; lifestyle data; sample collection; screening; tumor registry

The Division of Cancer Prevention and Control’s Board of Scientific Counselors approved the Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial in January 1991. Contracts were awarded in September 1992. Ten Screening Centers (SCs), a Coordinating Center (CC), and a Laboratory (Lab) were competitively selected. Screening began upon OMB approval of study forms in November 1993. The NCI Executive Committee approved Special Studies to investigate research topics using questionnaire and biological data on October 8, 1996. In 2009, the NCI Director approved the continuation of follow-up of PLCO participants beyond the originally planned 13-year follow-up period. As screening had now ended, the next phase of follow-up and associated data collection was thought to be more efficiently collected centrally by a new CDCC. In March 2011, a new contract to the CDCC was awarded (contract number: HHSN261201100008C) to Westat for a period of 5 years to permit centralized follow-up of all PLCO participants who consented to continuation in the study as either active (transfer to CDCC for follow-up activities as previously done at SCs) or passive (remain as PLCO participant through linkages conducted only by the SCs). (To date, a little less than $12,000,000 have been obligated to the contract.) Before the site contracts ended, participants were mailed consent forms informing them of the new centralized follow-up and given three options: 1) consent for active follow-up by transferring all PII and future data collection efforts to the CDCC; 2) consent for passive follow-up by their screening centers including linkages to healthcare databases such as state tumor registries, National Death Index, and Medicaid and Medicare; or 3) withdraw from PLCO. In this effort, nearly 20,000 participants or approximately 15% of the eligible PLCO participants at the time withdrew from the study completely, translating to a significant volume of data loss for this invaluable study. This renewal must be re-awarded to the current CDCC contractor so that we can avoid further data loss; awarding this contract to any other contractor would require another consent process, yielding further data loss which would be detrimental to the PLCO study. Extending follow-up of PLCO participants will add more important data to this rich scientific resource but only with as many eligible PLCO participants as possible. For this task order, implementation of a new questionnaire and initiation of a new specimen collection will increase the value of the PLCO data and specimen resource by allowing new types of analyses for risk factors for cancer

1991年1月，癌症预防和控制部科学顾问委员会批准了前列腺、肺、结肠直肠和卵巢（PLCO）癌症筛查试验。1992年9月授予了合同。通过竞争选择了10个筛选中心（SC）、1个协调中心（CC）和1个实验室（Lab）。1993年11月，在管理和预算办公室批准研究表格后开始筛选。NCI执行委员会于1996年10月8日批准了使用问卷和生物数据调查研究主题的特别研究。2009年，国家癌症研究所所长批准在原计划的13年随访期之后继续对PLCO参与者进行随访。 由于筛查现已结束，下一阶段的随访和相关数据收集被认为由新的CDCC集中收集更有效。 2011年3月，与CDCC签订了新合同（合同编号：HHSN 261201100008 C），为期5年，以便对同意继续参与研究的所有PLCO受试者进行集中随访，无论是主动（转移至CDCC进行随访活动，如之前在SC进行的那样）还是被动（通过仅由SC进行的联系保持PLCO受试者身份）。 (To截至2013年12月31日，合同承付款项略低于1200万美元。 在研究中心合同结束前，参与者收到了邮寄的同意书，告知他们新的集中随访，并有三种选择：1）同意通过将所有PII和未来的数据收集工作转移到CDCC进行主动随访; 2）同意由其筛查中心进行被动随访，包括与医疗保健数据库的链接，如州肿瘤登记处，国家死亡指数，医疗补助和医疗保险;（3）退出PLCO。 在这项工作中，近20，000名参与者或当时合格PLCO参与者的约15%完全退出了研究，这意味着这项宝贵研究的大量数据丢失。 必须将此续约重新授予当前的CDCC承包商，以便我们可以避免进一步的数据丢失;将此合同授予任何其他承包商将需要另一个同意过程，从而导致进一步的数据丢失，这将不利于PLCO研究。 延长PLCO参与者的后续行动将为这一丰富的科学资源增加更重要的数据，但只有尽可能多的合格PLCO参与者。 对于该任务订单，实施新的调查问卷和启动新的样本采集将通过允许对癌症风险因素进行新型分析来增加PLCO数据和样本资源的价值