A Targeted Approach to the Surveillance of Precursor Lesions for Gastric Cancer

胃癌前驱病变监测的有针对性的方法

• 批准号: 10215082
• 负责人: Monika Laszkowska
• 金额: $ 16.76万
• 依托单位: SLOAN-KETTERING INST CAN RESEARCH
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-05-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10215082
• 关键词: Accounting; Adult; Advisory Committees; Affect; Age; American; Asians; Award; Bass; Cancer Model; Clinical Research; Collection; Colorectal Cancer; Computer Simulation; Country; Coupled; Data; Databases; Development Plans; Diffuse gastric cancer; Dysplasia; Early Intervention; Epithelial; Ethnic Origin; Europe; Family; Female; Funding; Gastric Adenocarcinoma; Gastrointestinal tract structure; Gender; Guidelines; Health; Healthcare Systems; Helicobacter Infections; Helicobacter pylori; High Prevalence; Hispanics; Hospitals; Immigrant; Incidence; Individual; Infection; Inherited; Intervention; Investigation; Japan; Knowledge; Lesion; Low Prevalence; Malignant Neoplasms; Mass Screening; Mentorship; Modeling; Natural History; Not Hispanic or Latino; Operative Surgical Procedures; Outcome; Pathology; Patients; Phenotype; Policies; Population; Precancerous Conditions; Prevalence; Public Health; Publishing; Race; Randomized Controlled Trials; Recording of previous events; Regimen; Reporting; Research; Research Personnel; Risk; Risk Factors; SEER Program; Screening for Gastric Cancer; Smoking History; Societies; Specimen; Stomach; Subgroup; System; Testing; United States; United States Department of Veterans Affairs; United States National Institutes of Health; Veterans Health Administration; Work; base; biomarker signature; cancer subtypes; care costs; care outcomes; career; career development; cohort; cost; cost effective; cost-effectiveness ratio; curative treatments; ethnic difference; ethnic minority population; gastric intestinal metaplasia; gastrointestinal; high risk; i(19); improved; improved outcome; incremental cost-effectiveness; intervention program; male; malignant stomach neoplasm; models and simulation; mortality; premalignant; prevent; preventive intervention; profiles in patients; prophylactic; prospective; racial and ethnic; racial difference; response; risk stratification; screening; screening program; surveillance data

Project Summary/Abstract The proposed research will characterize the prevalence and management strategies of gastric intestinal metaplasia (GIM), a lesion of the digestive tract that affects about 12.1 million adults in the United States (US) and is a precursor to gastric adenocarcinoma, or gastric cancer (GC). While mass surveillance of GIM is unlikely to be effective in regions of low-prevalence for GC such as the US, we hypothesize that risk- stratification for targeted screening and surveillance will be cost-effective and can improve outcomes. Extensive GIM has been identified by gastrointestinal society guidelines as a major risk factor for progression to GC, but there is currently a dearth of evidence in understanding the prevalence of GIM overall and by subtype (limited and extensive) in the US population, or how it should be managed. Furthermore, the recently proposed guidelines from the American Gastroenterological Association suggest surveillance of GIM should be considered in racial/ethnic minorities, foreign-born individuals, or those with a history of Helicobacter pylori (H. pylori) infection; however, evidence on the threshold to initiate such interventions and the intervals at which they should be continued is lacking. The research proposed in this K08 application will accomplish three interrelated Specific Aims. In Aim 1, we will utilize data from across the Veterans Affairs health care system to characterize the prevalence of subtypes of GIM and risk factors for progression of GIM to dysplasia or malignancy in the US context. These data will provide a platform for Aim 2, in which we will build a simulation model of the natural history of progression from precancerous gastric lesions to GC to assess which individual- level risk factor profiles could benefit most from screening and surveillance of GIM. The model will utilize 64 different phenotypic profiles, stratified by: gender (male/female), race/ethnicity (non-Hispanic white, Hispanic, black, and Asian), extent of GIM (limited vs. extensive), foreign-born status (immigrant vs. US-born), and H. pylori infection status (previous/current infection vs. no infection). Outcomes will be reported based on number of cancers prevented, survival, and incremental cost-effectiveness ratios (ICERs). Once an optimal profile and screening regimen is identified on the patient level, in Aim 3 we will assess the population-level impact of implementing such a strategy on health care outcomes and costs in the US. The long window of progression from GIM to malignancy and the low incidence of GC make sufficiently powered randomized controlled trials difficult. Simulation modeling allows for the integration of available knowledge to test multiple surveillance regimens of GIM across a broad range of risk factor combinations, which would not be feasible in clinical studies. By award period end, the proposed research will utilize national pathology data coupled with simulation modeling to identify a specific subgroup of high-risk patients that may benefit most from surveillance in the US. The proposal, mentorship and advisory committee, career development plans and institutional support will lay the basis for an independent NIH-funded career.

项目摘要/摘要 拟议的研究将表征胃肠的患病率和管理策略 Metaplasia（GIM），一种消化道的病变，影响了美国约1,210万成年人（美国） 并且是胃腺癌或胃癌（GC）的前体。而GIM的质量监视是 对于美国等GC的低贫困地区，我们不太可能有效，我们假设风险 - 针对性筛查和监视的分层将具有成本效益，并且可以改善结果。 胃肠道社会指南已将广泛的GIM确定为进步的主要风险因素 到GC，但目前缺乏理解GIM总体流行率的证据 美国人口中的亚型（有限和广泛），或应如何管理。此外，最近 美国胃肠病学协会的拟议指南表明，GIM的监视应为 在种族/族裔少数民族，外国出生的人或具有幽门螺杆菌史的人（H. 幽门螺杆菌感染；但是，有关启动此类干预措施的阈值的证据以及 他们应该继续缺乏。在本k08应用程序中提出的研究将完成三个 相互关联的特定目标。在AIM 1中，我们将利用来自退伍军人事务医疗保健系统的数据 表征GIM亚型的患病率以及GIM发展到发育不良或的风险因素 在美国的情况下。这些数据将为AIM 2提供一个平台，我们将在其中构建模拟 从癌前胃病变到GC的自然历史模型，以评估哪个个体 水平风险因素概况可能会受益于GIM的筛查和监视。该模型将使用64 不同的表型特征，分层：性别（男性/女性），种族/种族（非西班牙裔白人，西班牙裔， 黑色和亚洲），GIM的范围（有限与广泛），外国出生的地位（移民与美国出生）和H. 幽门螺杆菌感染状态（以前/当前感染与无感染）。结果将根据数字进行报告 预防，生存和逐步成本效益比（ICER）的癌症的癌症。曾经是最佳配置文件， 筛查方案在患者级别上确定，在AIM 3中，我们将评估人口级别的影响 在美国实施有关医疗保健结果和成本的策略。长窗口窗口 从GIM到恶性肿瘤，GC的发病率低进行足够动力的随机对照试验 难的。仿真建模允许整合可用知识以测试多次监视 GIM的方案在广泛的风险因素组合中，这在临床上是不可行的 研究。到颁奖期结束时，拟议的研究将利用国家病理学数据与 模拟建模，以识别可能受益于监视的高风险患者的特定亚组 在美国。提案，指导和咨询委员会，职业发展计划和机构 支持将为独立NIH资助的职业提供基础。