Rationale and design of the Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) study. Sarcoidosis protocol

Details

• Personal Author:
  Adonteng-Boateng P ; Argula R ; Arnold D ; Atnes G ; Barbosa E ; Barkes B ; Becich M ; Beiko T ; Berry C ; Bhakta N ; Bowler R ; Breslin L ; Brooks M ; Brown K ; Bruno S ; Bushman F ; Carrano D ; Casanova N ; Chen E ; Collman R ; Collman RG ; Dawod Y ; Drake W ; Elliott J ; Fitzgerald A ; Garcia J ; Gardo L ; Ghedin E ; Gibson K ; Gibson KF ; Gillespie M ; Gulati M ; Hamzeh N ; Herzog E ; Ho M ; Hochheiser HS ; Imai I ; Kaminski N ; Kanukala S ; Knepler J Jr. ; Knox K ; Koth LL ; Kreider M ; Leader JK ; Li L ; MacPhail K ; Maier L ; Maier LA ; Moller D ; Moller DR ; Morris A ; Mroz P ; Navarrete J ; Oliva I ; O'Neal S ; Paoletti L ; Patterson K ; Ramstein J ; Riggs T ; Rissmiller R ; Robinson R ; Rossman M ; Sandhaus R ; Schnapp L ; Senior RM ; Silveira L ; Song Z ; Strange C ; Sun S ; Sweiss N ; Sweiss NJ ; Walker D ; Wisniewski SR ; Woodford D ; Woodruff P ; Zhang Y
• Corporate Authors:
  Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis
• Description:
  Sarcoidosis is a systemic disease characterized by noncaseating granulomatous inflammation with tremendous clinical heterogeneity and uncertain pathobiology and lacking in clinically useful biomarkers. The Genomic Research in Alpha-1 Antitrypsin Deficiency and Sarcoidosis (GRADS) study is an observational cohort study designed to explore the role of the lung microbiome and genome in these two diseases. This article describes the design and rationale for the GRADS study sarcoidosis protocol. The study addresses the hypothesis that distinct patterns in the lung microbiome are characteristic of sarcoidosis phenotypes and are reflected in changes in systemic inflammatory responses as measured by peripheral blood changes in gene transcription. The goal is to enroll 400 participants, with a minimum of 35 in each of 9 clinical phenotype subgroups prioritized by their clinical relevance to understanding of the pathobiology and clinical heterogeneity of sarcoidosis. Participants with a confirmed diagnosis of sarcoidosis undergo a baseline visit with self-administered questionnaires, chest computed tomography, pulmonary function tests, and blood and urine testing. A research or clinical bronchoscopy with a research bronchoalveolar lavage will be performed to obtain samples for genomic and microbiome analyses. Comparisons will be made by blood genomic analysis and with clinical phenotypic variables. A 6-month follow-up visit is planned to assess each participant's clinical course. By the use of an integrative approach to the analysis of the microbiome and genome in selected clinical phenotypes, the GRADS study is powerfully positioned to inform and direct studies on the pathobiology of sarcoidosis, identify diagnostic or prognostic biomarkers, and provide novel molecular phenotypes that could lead to improved personalized approaches to therapy for sarcoidosis. [Description provided by NIOSH]
• Subjects:
  Genetics Occupational Health Respiratory Tract Diseases Safety
• Keywords:
  Author Keywords: Bronchoalveolar Lavage Genes Humans Lung Microbiome Phenotype Pulmonary-system-disorders Respiratory-system-disorders Statistical-analysis Transcriptome
• ISSN:
  2329-6933
• Document Type:
  Text
• Funding:
  Cooperative Agreement
• Genre:
  Journal Article
• Place as Subject:
  California ; Colorado ; Connecticut ; Illinois ; Maryland ; Missouri ; OSHA Region 1 ; OSHA Region 3 ; OSHA Region 4 ; OSHA Region 5 ; OSHA Region 7 ; OSHA Region 8 ; OSHA Region 9 ; Pennsylvania ; Tennessee
• CIO:
  National Institute for Occupational Safety and Health (NIOSH)
• Topic:
  Workplace Safety & Health
• Location:
  North America
• Volume:
  12
• Issue:
  10
• NIOSHTIC Number:
  nn:20047496
• Citation:
  Ann Am Thorac Soc 2015 Oct; 12(10):1561-1571
• Contact Point Address:
  David R. Moller, M.D., Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine, 5501 Hopkins Bayview Circle, Baltimore, MD 21224
• Email:
  dmoller@jhmi.edu
• Federal Fiscal Year:
  2016
• NORA Priority Area:
  Construction ; Manufacturing
• Performing Organization:
  University of Pittsburgh at Pittsburgh
• Peer Reviewed:
  True
• Start Date:
  20060901
• Source Full Name:
  Annals of the American Thoracic Society
• End Date:
  20260831
• Collection(s):
  National Institute for Occupational Safety and Health
• Main Document Checksum:
  urn:sha-512:ac4a51d18a979c951186fc0a894e27b89fce43b6839a7e64b687b3e8b9eb3fa902776260ced02aaa3b4ba4eb4057217491e69cfccb021cb244e9674a00e82d4d
• Download URL:
  https://stacks.cdc.gov/view/cdc/202549/cdc_202549_DS1.pdf
• File Type:
  [PDF - 502.83 KB ]