Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005276
Status:
COMPLETED
Last Update Posted:
2016-03-25
First Post:
2000-05-25
Brief Title:
A Case Controlled Etiologic Study of Sarcoidosis ACCESS
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 100000 and prevalence from about 5 to 50 per 100000 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 10000 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
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 100000 and prevalence from about 5 to 50 per 100000 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 10000 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: