Role of Proteomics in Diagnosing Sarcoidosis

Sarcoidosis Clinical Trial

Official title:

Proteomics as a Tool for Biomarker Detection in Sarcoidosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626938
• Other study ID #: MEC 04-145.11
• Status: Completed
• Phase: N/A
• First received: February 14, 2008
• Last updated: November 5, 2012
• Start date: March 2005
• Est. completion date: March 2012

Study information

• Verified date: November 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Observational

Clinical Trial Summary

Sarcoidosis is a multi-systemic disorder, meaning that it can involve any organ in the body and that its clinical presentation is highly variable. In 90% of all sarcoidosis cases the lungs are affected. It is difficult to give a concise definition of sarcoidosis due to the fact that its exact cause is still unknown. Consequently, diagnosing the disease is also rather difficult. Up till now, sarcoidosis is generally diagnosed by using general clinical methods to evaluate the status of the lung including a chest X-ray, lung biopsy and bronchoalveolar lavage (BAL). However, some of these methods are considered to be rather invasive and, even more important, non-conclusive. Therefore, the current study has been designed to evaluate the use of a new technique, called SELDI-TOF mass spectrophotometry, for the diagnosis of sarcoidosis. This technique enables the analysis of all enzymes present in the blood of sarcoidosis patients which may hopefully lead to creating a disease-specific protein-profile that may facilitate the recognition of sarcoidosis. Moreover, these results will be compared with other currently used laboratory parameters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of pulmonary sarcoidosis stage I-IV

Exclusion Criteria:

• Non-smoking

• No treatment for extra-pulmonary symptoms of sarcoidosis

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Sarcoidosis

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (1)

Lead Sponsor	Collaborator
Maastricht University Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	protein profile in blood		within 1 month after obtaining sample	Yes
Secondary	CYP and TNF polymorphisms		within 6 months after obtaining sample	Yes

External Links

•   official site of ildcare foundation, ild= interstitial lung disease