Role of Proteomics in Diagnosing Sarcoidosis
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| First Received Date ICMJE | February 14, 2008 | ||||||||||||||||
| Last Updated Date | November 5, 2012 | ||||||||||||||||
| Start Date ICMJE | March 2005 | ||||||||||||||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
protein profile in blood [ Time Frame: within 1 month after obtaining sample ] [ Designated as safety issue: Yes ] | ||||||||||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT00626938 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
CYP and TNF polymorphisms [ Time Frame: within 6 months after obtaining sample ] [ Designated as safety issue: Yes ] | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Role of Proteomics in Diagnosing Sarcoidosis | ||||||||||||||||
| Official Title ICMJE | 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. |
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| Detailed Description | Not Provided | ||||||||||||||||
| Study Type ICMJE | Observational | ||||||||||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Cross-Sectional |
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| 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. |
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| Sampling Method | Non-Probability Sample | ||||||||||||||||
| Study Population | Patients visiting the out-patient clinic of the university hospital Maastricht. |
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| Condition ICMJE | Sarcoidosis | ||||||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||||||
| Enrollment ICMJE | 1000 | ||||||||||||||||
| Completion Date | March 2012 | ||||||||||||||||
| Primary Completion Date | March 2012 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | 18 Years to 70 Years | ||||||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | Netherlands | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT00626938 | ||||||||||||||||
| Other Study ID Numbers ICMJE | MEC 04-145.11 | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | marjolein drent, Maastricht University Medical Center | ||||||||||||||||
| Study Sponsor ICMJE | Maastricht University Medical Center | ||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Maastricht University Medical Center | ||||||||||||||||
| Verification Date | November 2012 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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