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A Case Controlled Etiologic Study of Sarcoidosis (ACCESS)

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ClinicalTrials.gov Identifier: NCT00005276
Recruitment Status : Completed
First Posted : May 26, 2000
Last Update Posted : March 25, 2016
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary:
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.

Condition or disease
Lung Diseases Sarcoidosis

Detailed Description:


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.


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.

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Study Type : Observational
Study Start Date : June 1995
Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
No eligibility criteria

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005276

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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OverallOfficial: Robert Baughman University of Cincinnati
OverallOfficial: Michael Iannuzzi Henry Ford Hospital
OverallOfficial: Marc Judson Medical University of South Carolina
OverallOfficial: Genell Knatterud Clinical Trials and Survey Corporation
OverallOfficial: Geoffrey McLennan University of Iowa
OverallOfficial: David Moller Johns Hopkins University
OverallOfficial: Lee Newman National Jewish Center for Immunology & Respiratory Medicine
OverallOfficial: Milton Rossman University of Pennsylvania
OverallOfficial: Alvin Teirstein Icahn School of Medicine at Mount Sinai
OverallOfficial: Steven Weinberger Beth Israel Hospital
OverallOfficial: Henry, Yeager Georgetown University
Study Data/Documents: Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: ACCESS
NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.


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ClinicalTrials.gov Identifier: NCT00005276    
Other Study ID Numbers: 1303
First Posted: May 26, 2000    Key Record Dates
Last Update Posted: March 25, 2016
Last Verified: December 2005
Additional relevant MeSH terms:
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Lung Diseases
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases