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A Case Controlled Etiologic Study of Sarcoidosis (ACCESS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00005276
First Posted: May 26, 2000
Last Update Posted: March 25, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
No eligibility criteria
  Contacts and Locations
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)
Investigators
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
  More Information

Publications:

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.

ClinicalTrials.gov Identifier: NCT00005276     History of Changes
Other Study ID Numbers: 1303
First Submitted: May 25, 2000
First Posted: May 26, 2000
Last Update Posted: March 25, 2016
Last Verified: December 2005

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