Role of Proteomics in Diagnosing Sarcoidosis

NCT00626938 | Completed

• 1 other identifier: MEC 04-145.11
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcoidosis

Keywords

sarcoidosis; protein profile; CYP-450; TNF-alpha polymorphisms; HLA

Outcome Measures

Primary Outcomes (1)

• protein profile in blood

  within 1 month after obtaining sample

Secondary Outcomes (1)

• CYP and TNF polymorphisms

  within 6 months after obtaining sample

Study Arms (2)

sarcoidosis

sarcoidosis patients

controls

healthy volunteers and other interstitial lung disease (ILD) patients

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Clinical diagnosis of pulmonary sarcoidosis stage I-IV

You may not qualify if:

• Non-smoking
• No treatment for extra-pulmonary symptoms of sarcoidosis

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Centre

Maastricht, 6202 AZ, Netherlands

Location

Related Links

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

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Sarcoidosis

Condition Hierarchy (Ancestors)

Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases

Study Officials

• Marjolein Drent, Prof,MD,PhD

  University Hospital Maastricht, Departement of Respiratory Medicine

  STUDY DIRECTOR

• Otto Bekers, PhD

  University Hospital Maastricht, Departement of Clinical Chemistry

  PRINCIPAL INVESTIGATOR

• Christine Voorter, PhD

  University Hospital Maastricht, Departement of Tissue Typing

  PRINCIPAL INVESTIGATOR

• Marja P van Dieijen-Visser, Prof,MSc,PhD

  University Hospital Maastricht, Departement of Clinical Chemistry

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Marjolein Drent

Study Record Dates

• First Submitted: February 14, 2008
• First Posted: February 29, 2008
• Study Start: March 1, 2005
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: November 7, 2012

Record last verified: 2012-11

Locations

NL (1)