A Case Controlled Etiologic Study of Sarcoidosis (ACCESS)

NCT ID: NCT00005276

Last Updated: 2016-03-25

Basic Information

• Recruitment Status: COMPLETED
• Study Classification: OBSERVATIONAL
• Study Start Date: 1995-06-30
• Study Completion Date: 2003-03-31

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.

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.

Conditions

Lung Diseases; Sarcoidosis

Eligibility Criteria

Inclusion Criteria

No eligibility criteria

• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: lead

Principal Investigators

Robert Baughman

Role:

University of Cincinnati

Michael Iannuzzi

Role:

Henry Ford Hospital

Marc Judson

Role:

Medical University of South Carolina

Genell Knatterud

Role:

Clinical Trials and Survey Corporation

Geoffrey McLennan

Role:

University of Iowa

David Moller

Role:

Johns Hopkins University

Lee Newman

Role:

National Jewish Center for Immunology & Respiratory Medicine

Milton Rossman

Role:

University of Pennsylvania

Alvin Teirstein

Role:

Icahn School of Medicine at Mount Sinai

Steven Weinberger

Role:

Beth Israel Hospital

Henry, Yeager

Role:

Georgetown University

References

Gond NY, Khadabadi SS. Hepatoprotective Activity of Ficus carica Leaf Extract on Rifampicin-Induced Hepatic Damage in Rats. Indian J Pharm Sci. 2008 May-Jun;70(3):364-6. doi: 10.4103/0250-474X.43003.

Reference Type: BACKGROUND

PMID: 20046747 (View on PubMed)

Judson MA, Baughman RP, Teirstein AS, Terrin ML, Yeager H Jr. Defining organ involvement in sarcoidosis: the ACCESS proposed instrument. ACCESS Research Group. A Case Control Etiologic Study of Sarcoidosis. Sarcoidosis Vasc Diffuse Lung Dis. 1999 Mar;16(1):75-86.

Reference Type: BACKGROUND

PMID: 10207945 (View on PubMed)

Rybicki BA, Iannuzzi MC, Frederick MM, Thompson BW, Rossman MD, Bresnitz EA, Terrin ML, Moller DR, Barnard J, Baughman RP, DePalo L, Hunninghake G, Johns C, Judson MA, Knatterud GL, McLennan G, Newman LS, Rabin DL, Rose C, Teirstein AS, Weinberger SE, Yeager H, Cherniack R; ACCESS Research Group. Familial aggregation of sarcoidosis. A case-control etiologic study of sarcoidosis (ACCESS). Am J Respir Crit Care Med. 2001 Dec 1;164(11):2085-91. doi: 10.1164/ajrccm.164.11.2106001.

Reference Type: BACKGROUND

PMID: 11739139 (View on PubMed)

Baughman RP, Teirstein AS, Judson MA, Rossman MD, Yeager H Jr, Bresnitz EA, DePalo L, Hunninghake G, Iannuzzi MC, Johns CJ, McLennan G, Moller DR, Newman LS, Rabin DL, Rose C, Rybicki B, Weinberger SE, Terrin ML, Knatterud GL, Cherniak R; Case Control Etiologic Study of Sarcoidosis (ACCESS) research group. Clinical characteristics of patients in a case control study of sarcoidosis. Am J Respir Crit Care Med. 2001 Nov 15;164(10 Pt 1):1885-9. doi: 10.1164/ajrccm.164.10.2104046.

Reference Type: BACKGROUND

PMID: 11734441 (View on PubMed)

Freemer M, King TE Jr. The ACCESS study: characterization of sarcoidosis in the United States. Am J Respir Crit Care Med. 2001 Nov 15;164(10 Pt 1):1754-5. doi: 10.1164/ajrccm.164.10.2109111b. No abstract available.

Reference Type: BACKGROUND

PMID: 11734416 (View on PubMed)

Rossman M, Thompson B, Frederick M, Cizman B, Magira E, Monos D. Sarcoidosis: association with human leukocyte antigen class II amino acid epitopes and interaction with environmental exposures. Chest. 2002 Mar;121(3 Suppl):14S. doi: 10.1378/chest.121.3_suppl.14s. No abstract available.

Reference Type: BACKGROUND

PMID: 11893656 (View on PubMed)

Pandey JP, Frederick M; ACCESS Research Group. A Case Control Etiologic Study of Sarcoidosis. TNF-alpha, IL1-beta, and immunoglobulin (GM and KM) gene polymorphisms in sarcoidosis. Hum Immunol. 2002 Jun;63(6):485-91. doi: 10.1016/s0198-8859(02)00399-3.

Reference Type: BACKGROUND

PMID: 12039524 (View on PubMed)

Judson MA, Baughman RP, Thompson BW, Teirstein AS, Terrin ML, Rossman MD, Yeager H Jr, McLennan G, Bresnitz EA, DePalo L, Hunninghake G, Iannuzzi MC, Johns CJ, Moller DR, Newman LS, Rabin DL, Rose C, Rybicki BA, Weinberger SE, Knatterud GL, Cherniak R; ACCESS Research Group. Two year prognosis of sarcoidosis: the ACCESS experience. Sarcoidosis Vasc Diffuse Lung Dis. 2003 Oct;20(3):204-11.

Reference Type: BACKGROUND

PMID: 14620163 (View on PubMed)

Rossman MD, Thompson B, Frederick M, Maliarik M, Iannuzzi MC, Rybicki BA, Pandey JP, Newman LS, Magira E, Beznik-Cizman B, Monos D; ACCESS Group. HLA-DRB1*1101: a significant risk factor for sarcoidosis in blacks and whites. Am J Hum Genet. 2003 Oct;73(4):720-35. doi: 10.1086/378097. Epub 2003 Aug 20.

Reference Type: BACKGROUND

PMID: 14508706 (View on PubMed)

Newman LS, Rose CS, Bresnitz EA, Rossman MD, Barnard J, Frederick M, Terrin ML, Weinberger SE, Moller DR, McLennan G, Hunninghake G, DePalo L, Baughman RP, Iannuzzi MC, Judson MA, Knatterud GL, Thompson BW, Teirstein AS, Yeager H Jr, Johns CJ, Rabin DL, Rybicki BA, Cherniack R; ACCESS Research Group. A case control etiologic study of sarcoidosis: environmental and occupational risk factors. Am J Respir Crit Care Med. 2004 Dec 15;170(12):1324-30. doi: 10.1164/rccm.200402-249OC. Epub 2004 Sep 3.

Reference Type: BACKGROUND

PMID: 15347561 (View on PubMed)

Taylor AN, Cullinan P. Sarcoidosis: in search of the cause. Am J Respir Crit Care Med. 2004 Dec 15;170(12):1268-9. doi: 10.1164/rccm.2409006. No abstract available.

Reference Type: BACKGROUND

PMID: 15590884 (View on PubMed)

Rybicki BA, Walewski JL, Maliarik MJ, Kian H, Iannuzzi MC; ACCESS Research Group. The BTNL2 gene and sarcoidosis susceptibility in African Americans and Whites. Am J Hum Genet. 2005 Sep;77(3):491-9. doi: 10.1086/444435. Epub 2005 Jul 20.

Reference Type: BACKGROUND

PMID: 16080124 (View on PubMed)

Yeager H, Rossman MD, Baughman RP, Teirstein AS, Judson MA, Rabin DL, Iannuzzi MC, Rose C, Bresnitz EA, DePalo L, Hunninghakes G, Johns CJ, McLennan G, Moller DR, Newman LS, Rybicki B, Weinberger SE, Wilkins PC, Cherniack R; ACCESS Research Group. Pulmonary and psychosocial findings at enrollment in the ACCESS study. Sarcoidosis Vasc Diffuse Lung Dis. 2005 Jun;22(2):147-53.

Reference Type: BACKGROUND

PMID: 16053031 (View on PubMed)

Barnard J, Rose C, Newman L, Canner M, Martyny J, McCammon C, Bresnitz E, Rossman M, Thompson B, Rybicki B, Weinberger SE, Moller DR, McLennan G, Hunninghake G, DePalo L, Baughman RP, Iannuzzi MC, Judson MA, Knatterud GL, Teirstein AS, Yeager H Jr, Johns CJ, Rabin DL, Cherniack R; ACCESS Research Group. Job and industry classifications associated with sarcoidosis in A Case-Control Etiologic Study of Sarcoidosis (ACCESS). J Occup Environ Med. 2005 Mar;47(3):226-34. doi: 10.1097/01.jom.0000155711.88781.91.

Reference Type: BACKGROUND

PMID: 15761318 (View on PubMed)

Teirstein AS, Judson MA, Baughman RP, Rossman MD, Yeager H Jr, Moller DR; Case Control Etiologic Study of Sarcoidosis (ACCESS) Writing Group. The spectrum of biopsy sites for the diagnosis of sarcoidosis. Sarcoidosis Vasc Diffuse Lung Dis. 2005 Jun;22(2):139-46.

Reference Type: BACKGROUND

PMID: 16053030 (View on PubMed)

Study Documents

Document Type: Individual Participant Data Set

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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Document Type: Study Protocol

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Document Type: Study Forms

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Document Type: Procedures Manual

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Other Identifiers

1303

Identifier Type: -

Identifier Source: org_study_id