Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Role of Proteomics in Diagnosing Sarcoidosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00626938
Recruitment Status : Completed
First Posted : February 29, 2008
Last Update Posted : November 7, 2012
Sponsor:
Information provided by (Responsible Party):
marjolein drent, Maastricht University Medical Center

Tracking Information
First Submitted Date February 14, 2008
First Posted Date February 29, 2008
Last Update Posted Date November 7, 2012
Study Start Date March 2005
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2008)
protein profile in blood [ Time Frame: within 1 month after obtaining sample ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 28, 2008)
CYP and TNF polymorphisms [ Time Frame: within 6 months after obtaining sample ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Role of Proteomics in Diagnosing Sarcoidosis
Official Title Proteomics as a Tool for Biomarker Detection in Sarcoidosis
Brief 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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood will be collected from all participants, but all samples will be stored anonymously.
Sampling Method Non-Probability Sample
Study Population Patients visiting the out-patient clinic of the university hospital Maastricht.
Condition Sarcoidosis
Intervention Not Provided
Study Groups/Cohorts
  • sarcoidosis
    sarcoidosis patients
  • controls
    healthy volunteers and other interstitial lung disease (ILD) patients
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 28, 2008)
1000
Original Estimated Enrollment Same as current
Actual Study Completion Date March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Clinical diagnosis of pulmonary sarcoidosis stage I-IV

Exclusion Criteria:

  • Non-smoking
  • No treatment for extra-pulmonary symptoms of sarcoidosis
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT00626938
Other Study ID Numbers MEC 04-145.11
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party marjolein drent, Maastricht University Medical Center
Study Sponsor Maastricht University Medical Center
Collaborators Not Provided
Investigators
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
PRS Account Maastricht University Medical Center
Verification Date November 2012