India - Factors of CKDu in Uddanam Study (India-FOCUS)

印度 - Uddanam 研究中 CKDu 的因素 (India-FOCUS)

基本信息

批准号：
10471938
负责人：
Vivekanand Jha
金额：
$ 52.2万
依托单位：
COLUMBIA UNIVERSITY HEALTH SCIENCES
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-08-25 至 2026-06-30
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10471938
关键词：
Address Adult Affect Age Agriculture Air Alcohols Analgesics Area Biological Markers Biopsy Blood Chronic Kidney Failure Clinical Cohort Studies Collaborations Collection Communities Country Coupled Cross-Sectional Studies Data Development Diabetes Mellitus Disease Disease Progression Dose Environment Environmental Epidemiology Environmental Exposure Environmental Risk Factor Environmental Science Environmental and Occupational Exposure Etiology Evaluation Family First Degree Relative Frequencies Future Gender General Population Genes Genetic Genetic Predisposition to Disease Glomerular Filtration Rate Hair Health system Healthcare Systems Heat Stress Disorders Hematuria Heterogeneity Household Hypertension India Individual Infection Injury Injury to Kidney Intervention Kidney Diseases Leadership Location Longitudinal Studies Manuals Measurement Measures Medical Medical History Nail plate Non-Steroidal Anti-Inflammatory Agents Occupational Occupations Participant Pathway interactions Patients Pattern Perception Pesticides Phenotype Poison Population Prevalence Prevention Preventive Proteinuria Protocols documentation Public Health Questionnaires Recording of previous events Renal function Research Resource-limited setting Risk Factors Sample Size Sampling Seasonal Variations Silicones Soil Spouses Standardization State Government Sustainable Development Testing Time Tobacco smoking behavior Translating Urine Visit Water Work age group agricultural community case control clinical examination cohort community engagement design disability epidemiology study experience follow-up genetic pedigree genetic risk factor kidney biopsy longitudinal analysis low socioeconomic status member mortality multidisciplinary patient subsets phenotypic data pollutant programs prospective public health intervention recruit sample collection sex therapy design

项目摘要

Summary This proposal describes the formation of an experienced multidisciplinary team that is well equipped to complete a comprehensive field epidemiology study of chronic kidney disease of uncertain etiology (CKDu) in the endemic region of Uddanam in South India. This India-FOCUS (India- Factors of CKDu in Uddanam Study) team represents well-established experts in kidney disease, epidemiology environmental science, and project management as well as extensive experience in field work in low resource settings. The India-FOCUS team, who have long standing prior collaborations, will facilitate the successful establishment of a case control longitudinal study that includes 400 participants with CKDu and 800 controls with repeated visits every 9 months. The recruitment strategy for participants with CKDu is designed to allow for careful study of the known familial clustering by the inclusion of at least 100 families with 2 or more affected individuals. Recruited controls will be matched to cases by age, sex, location and occupation. Study participants will undergo careful phenotyping including a detailed medical history, exposure history, standardized validated questionnaires, detailed family pedigree charts, clinical examination. The study will collect biospecimens (blood, urine, hair, nails) from all participants at regular prespecified intervals to measure kidney function, biomarkers of kidney injury, and biomarkers of various environmental exposures (Aim 1a & 1b). A subset of patients will undergo detailed evaluation of heat stress and additional precise measurements of glomerular filtration rate. We will also implement a detailed environmental sample (air, water, soil, silicone bands) collection protocol that will parallel biospecimen collection to facilitate targeted and untargeted analyses of environmental exposures (Aim 2). The results of individual testing and environmental samples will be appropriately returned to the study participants and the community at appropriate time points to help inform the development of effective preventive and interventive measures (Aim 3). Study participants will be followed longitudinally and incident CKDu cases will be identified among the controls. Our study is designed to identify the genetics, exposome and gene-environmental interactions that represent the underlying etiology and risk factors for progression of CKDu. Community engagement will allow the development of sustainable interventions to reduce the burden of CKDu in these communities.

概括该提案描述了一支经验丰富的多学科团队的组建，该团队装备精良，能够完成对病因不明的慢性肾脏病 (CKDu) 的全面现场流行病学研究印度南部 Uddanam 的流行地区。印度-焦点（印度- Uddanam 研究中 CKDu 的因素）团队代表肾脏疾病、流行病学、环境科学和项目领域的知名专家管理以及在资源匮乏环境下的实地工作的丰富经验。 India-FOCUS 团队，之前有长期合作关系，将有助于案件控制的成功建立纵向研究，包括 400 名 CKDu 参与者和 800 名对照者，每 9 次重复访问几个月。 CKDu 参与者的招募策略旨在允许仔细研究已知的家庭聚类，包括至少 100 个有 2 名或更多受影响个体的家庭。招募控制人员将按年龄、性别、地点和职业与病例进行匹配。研究参与者将接受仔细的表型分析，包括详细的病史、暴露史、标准化验证问卷、详细的家族谱系图、临床检查。该研究将收集生物样本（血液、尿液、头发、定期对所有参与者进行指甲）测量，以测量肾功能、肾脏生物标志物损伤和各种环境暴露的生物标志物（目标 1a 和 1b）。一部分患者将接受热应激的详细评估和肾小球滤过率的额外精确测量。我们将还实施详细的环境样本（空气、水、土壤、硅胶带）收集协议，该协议将并行生物样本收集，以促进对环境暴露的有针对性和无针对性的分析（目标 2）。个别测试和环境样本的结果将适当返回给研究参与者和社区在适当的时间点帮助制定有效的预防和干预措施（目标 3）。将纵向跟踪研究参与者和事件 CKDu 病例将在对照中被识别。我们的研究旨在识别遗传学、暴露组以及代表疾病进展的潜在病因和危险因素的基因-环境相互作用 CKDu。社区参与将有助于制定可持续的干预措施，以减轻人们的负担这些社区中的 CKDu。