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
  Purpose

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.


Condition
Sarcoidosis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Proteomics as a Tool for Biomarker Detection in Sarcoidosis

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • protein profile in blood [ Time Frame: within 1 month after obtaining sample ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • CYP and TNF polymorphisms [ Time Frame: within 6 months after obtaining sample ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

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


Enrollment: 1000
Study Start Date: March 2005
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
sarcoidosis
sarcoidosis patients
controls
healthy volunteers and other interstitial lung disease (ILD) patients

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Clinical diagnosis of pulmonary sarcoidosis stage I-IV

Exclusion Criteria:

  • Non-smoking
  • No treatment for extra-pulmonary symptoms of sarcoidosis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00626938

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht University Medical Center
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
  More Information

Additional Information:
No publications provided

Responsible Party: marjolein drent, Prof. Marjolein Drent, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT00626938     History of Changes
Other Study ID Numbers: MEC 04-145.11
Study First Received: February 14, 2008
Last Updated: November 5, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Maastricht University Medical Center:
sarcoidosis
protein profile
CYP-450
TNF-alpha polymorphisms
HLA

Additional relevant MeSH terms:
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on October 19, 2014