Role of Proteomics in Diagnosing Sarcoidosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
marjolein drent, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT00626938
First received: February 14, 2008
Last updated: November 5, 2012
Last verified: November 2012

February 14, 2008
November 5, 2012
March 2005
March 2012   (final data collection date for primary outcome measure)
protein profile in blood [ Time Frame: within 1 month after obtaining sample ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00626938 on ClinicalTrials.gov Archive Site
CYP and TNF polymorphisms [ Time Frame: within 6 months after obtaining sample ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Role of Proteomics in Diagnosing Sarcoidosis
Proteomics as a Tool for Biomarker Detection in Sarcoidosis

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.

Not Provided
Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
Not Provided
Retention:   Samples With DNA
Description:

Blood will be collected from all participants, but all samples will be stored anonymously.

Non-Probability Sample

Patients visiting the out-patient clinic of the university hospital Maastricht.

Sarcoidosis
Not Provided
  • sarcoidosis
    sarcoidosis patients
  • controls
    healthy volunteers and other interstitial lung disease (ILD) patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
March 2012
March 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Clinical diagnosis of pulmonary sarcoidosis stage I-IV

Exclusion Criteria:

  • Non-smoking
  • No treatment for extra-pulmonary symptoms of sarcoidosis
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00626938
MEC 04-145.11
No
marjolein drent, Maastricht University Medical Center
Maastricht University Medical Center
Not Provided
Study Director: Marjolein Drent, Prof,MD,PhD University Hospital Maastricht, Departement of Respiratory Medicine
Principal Investigator: Otto Bekers, PhD University Hospital Maastricht, Departement of Clinical Chemistry
Principal Investigator: Christine Voorter, PhD University Hospital Maastricht, Departement of Tissue Typing
Study Chair: Marja P van Dieijen-Visser, Prof,MSc,PhD University Hospital Maastricht, Departement of Clinical Chemistry
Maastricht University Medical Center
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP