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| Tracking Information | |||||||||||||||||||||||||||||||||||||||||||||
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| First Received Date ICMJE | May 25, 2000 | ||||||||||||||||||||||||||||||||||||||||||||
| Last Updated Date | December 21, 2005 | ||||||||||||||||||||||||||||||||||||||||||||
| Start Date ICMJE | June 1995 | ||||||||||||||||||||||||||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||||||||||||||||||||||||||
| Current Primary Outcome Measures ICMJE | |||||||||||||||||||||||||||||||||||||||||||||
| Original Primary Outcome Measures ICMJE | |||||||||||||||||||||||||||||||||||||||||||||
| Change History | Complete list of historical versions of study NCT00005276 on ClinicalTrials.gov Archive Site | ||||||||||||||||||||||||||||||||||||||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||||||||||||||||||||||||||||||||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||||||||||||||||||||||||||||||||||||||
| Descriptive Information | |||||||||||||||||||||||||||||||||||||||||||||
| Brief Title ICMJE | A Case Controlled Etiologic Study of Sarcoidosis (ACCESS) | ||||||||||||||||||||||||||||||||||||||||||||
| Official Title ICMJE | |||||||||||||||||||||||||||||||||||||||||||||
| 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. |
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| 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. |
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| Study Phase | |||||||||||||||||||||||||||||||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||||||||||||||||||||||||||||||
| Study Design ICMJE | Natural History, Case Control | ||||||||||||||||||||||||||||||||||||||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||||||||||||||||||||||||||||||||||||||
| Study Arms / Comparison Groups | |||||||||||||||||||||||||||||||||||||||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||||||||||||||||||||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||||||||||||||||||||||||||||||
| Enrollment ICMJE | |||||||||||||||||||||||||||||||||||||||||||||
| Completion Date | March 2003 | ||||||||||||||||||||||||||||||||||||||||||||
| Primary Completion Date | |||||||||||||||||||||||||||||||||||||||||||||
| Eligibility Criteria ICMJE | No eligibility criteria |
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| Gender | Both | ||||||||||||||||||||||||||||||||||||||||||||
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| Accepts Healthy Volunteers | No | ||||||||||||||||||||||||||||||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||||||||||||||||||||||||||||||
| Location Countries ICMJE | |||||||||||||||||||||||||||||||||||||||||||||
| Administrative Information | |||||||||||||||||||||||||||||||||||||||||||||
| NCT ID ICMJE | NCT00005276 | ||||||||||||||||||||||||||||||||||||||||||||
| Responsible Party | |||||||||||||||||||||||||||||||||||||||||||||
| Study ID Numbers ICMJE | 1303 | ||||||||||||||||||||||||||||||||||||||||||||
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||||||||||||||||||||||||||||||||||||||
| Collaborators ICMJE | |||||||||||||||||||||||||||||||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | National Heart, Lung, and Blood Institute (NHLBI) | ||||||||||||||||||||||||||||||||||||||||||||
| Verification Date | December 2005 | ||||||||||||||||||||||||||||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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