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A Case Controlled Etiologic Study of Sarcoidosis (ACCESS)
This study has been completed.
Study NCT00005276   Information provided by National Heart, Lung, and Blood Institute (NHLBI)
First Received: May 25, 2000   Last Updated: December 21, 2005   History of Changes

May 25, 2000
December 21, 2005
June 1995
 
 
 
Complete list of historical versions of study NCT00005276 on ClinicalTrials.gov Archive Site
 
 
 
A Case Controlled Etiologic Study of Sarcoidosis (ACCESS)
 

To test specific hypotheses concerning environmental, occupational, lifestyle, and other risk factors for sarcoidosis. Also, to examine the familial aggregation of sarcoidosis and to test genetic hypotheses concerning its etiology. Finally, to describe the natural history of sarcoidosis, particularly in African-Americans who appear to be disproportionately affected, and to implement a system for storing biological specimens including blood cells, plasma, and serum.

BACKGROUND:

Sarcoidosis is a systemic granulomatous disorder of unknown etiology. While recognized as a distinct clinical entity for over a century, information on incidence, prevalence, risk factors, and natural history in the United States remains quite limited. Data available on the occurrence in the United States indicate that the incidence ranges from about 1 to 10 per 100,000 and prevalence from about 5 to 50 per 100,000. Incidence appears highest for young adults, ages 25 to 40, higher in females than males, and much greater in African Americans than other ethnic groups. Morbidity from this chronic disease is not well estimated by mortality data. In 1981, there were over 10,000 discharges from United States hospitals for sarcoidosis. Like mortality data, the hospital discharge information probably substantially underestimates the morbidity associated with sarcoidosis which is typically managed on an outpatient basis.

The Requests for Proposals were issued in September, 1994. Awards were made in June, 1995.

DESIGN NARRATIVE:

Each of ten clinical centers enrolled patients with sarcoidosis. Because population-based case-finding mechanisms have not been widely implemented for sarcoidosis, an institution-based rather than a population-based design was used. Participating institutions were located in geographic regions where the disease was known and ethnic and gender factors could be addressed. Several investigator-initiated studies were carried out.

In addition to etiology, ACCESS examined the socioeconomic status and clinical course of patients with sarcoidosis. Newly diagnosed cases of sarcoidosis were compared to age, sex, and race matched controls. Leads to the etiology of sarcoidosis have come from diverse sources: in clinical laboratory investigations, alveolitis has been found to precede granulomatous inflammation; in case control studies, familial aggregation has been identified; and in case reports, recurrence of granulomatous inflammation has been observed after lung transplantation.

 
Observational
Natural History, Case Control
  • Lung Diseases
  • Sarcoidosis
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
March 2003
 

No eligibility criteria

Both
 
No
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00005276
 
1303
National Heart, Lung, and Blood Institute (NHLBI)
 
Investigator: Robert Baughman University of Cincinnati
Investigator: Michael Iannuzzi Henry Ford Hospital
Investigator: Marc Judson Medical University of South Carolina
Investigator: Genell Knatterud Clinical Trials and Survey Corporation
Investigator: Geoffrey McLennan University of Iowa
Investigator: David Moller Johns Hopkins University
Investigator: Lee Newman National Jewish Center for Immunology & Respiratory Medicine
Investigator: Milton Rossman University of Pennsylvania
Investigator: Alvin Teirstein Mount Sinai School of Medicine
Investigator: Steven Weinberger Beth Israel Hospital
Investigator: Henry, Yeager Georgetown University
National Heart, Lung, and Blood Institute (NHLBI)
December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP