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
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|Condition or disease|
|Lung Diseases Sarcoidosis|
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.
|Study Type :||Observational|
|Study Start Date :||June 1995|
|Study Completion Date :||March 2003|
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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|
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
|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|
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.
|Other Study ID Numbers:||
|First Posted:||May 26, 2000 Key Record Dates|
|Last Update Posted:||March 25, 2016|
|Last Verified:||December 2005|
Respiratory Tract Diseases