A Case Controlled Etiologic Study of Sarcoidosis (ACCESS)

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00005276
First received: May 25, 2000
Last updated: December 21, 2005
Last verified: December 2005
  Purpose

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
Lung Diseases
Sarcoidosis

Study Type: Observational

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: June 1995
Estimated Study Completion Date: March 2003
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

No eligibility criteria

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005276

Sponsors and Collaborators
Investigators
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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00005276     History of Changes
Other Study ID Numbers: 1303
Study First Received: May 25, 2000
Last Updated: December 21, 2005
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Diseases
Sarcoidosis
Respiratory Tract Diseases
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on April 17, 2014