A Case Controlled Etiologic Study of Sarcoidosis (ACCESS)

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

N/A

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00005276
Study type	Observational
Source	National Heart, Lung, and Blood Institute (NHLBI)
Contact
Status	Completed
Phase	N/A
Start date	June 1995
Completion date	March 2003

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05563701` - Evaluation of the LVivo Image Quality Scoring (IQS)
Completed	`NCT04908397` - Carnitine Consumption and Augmentation in Pulmonary Arterial Hypertension	Phase 1
Terminated	`NCT03309358` - A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis	Phase 1
Completed	`NCT03682354` - ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery	N/A
Enrolling by invitation	`NCT03683186` - A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension	Phase 3
Completed	`NCT03626519` - Effects of Menthol on Dyspnoea in COPD Patients	N/A
Recruiting	`NCT06004440` - Real World Registry for Use of the Ion Endoluminal System
Completed	`NCT04874948` - Absorption, Elimination and Safety of 14C-labeled Radioactive BTZ-043, a New Compound in TB Treatment	Phase 1
Completed	`NCT02926768` - Phase I/II Study of CK-101 in NSCLC Patients and Other Advanced Solid Tumors	Phase 1
Completed	`NCT01443845` - Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)	Phase 4
Terminated	`NCT00233207` - IC14 Antibodies to Treat Individuals With Acute Lung Injury	Phase 2
Completed	`NCT00281216` - Innate and Adaptive Immunity in Individuals Experiencing Chronic Obstructive Pulmonary Disease Exacerbations	N/A
Completed	`NCT00269256` - Stress, Environment, and Genetics in Urban Children With Asthma	N/A
Recruiting	`NCT00129350` - Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation	Phase 1
Active, not recruiting	`NCT00115297` - Montelukast for Early Life Wheezing	Phase 2/Phase 3
Completed	`NCT00091767` - Genetic Studies in Difficult to Treat Asthma: TENOR	N/A
Completed	`NCT00094276` - Intervention for Improving Asthma Care for Minority Children in Head Start	N/A
Completed	`NCT00083798` - Family Linkage Study of Obstructive Sleep Apnea (OSA) in Iceland	N/A
Completed	`NCT00069823` - Study of Acid Reflux in Asthma	Phase 3
Completed	`NCT00089752` - Continuous Positive Airway Pressure to Improve Milder Obstructive Sleep Apnea	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.