Role of Proteomics in Diagnosing Sarcoidosis
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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 |
- protein profile in blood [ Time Frame: within 1 month after obtaining sample ] [ Designated as safety issue: Yes ]
- 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 |
Patients visiting the out-patient clinic of the university hospital Maastricht.
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| Netherlands | |
| Maastricht University Medical Centre | |
| Maastricht, Netherlands, 6202 AZ | |
| 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 May 23, 2013