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Tracking Information | |||||
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First Received Date † | June 3, 2008 | ||||
Last Updated Date | February 18, 2009 | ||||
Start Date † | February 2009 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00691340 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Cellular Proteome From Leukocytes of Glaucoma Patients in Comparison With Patients With Alzheimer's Disease | ||||
Official Title † | Systematic Characterization of the Cellular Proteome From Human Leukocytes of Glaucoma Patients in Comparison With Patients With Alzheimer's Disease | ||||
Brief Summary | Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the final end point in blinding diseases of the optic nerve such as glaucoma. It is known that neuronal cell death in glaucoma occurs by an apoptotic mechanism. In earlier studies the investigators could demonstrate that the process of apoptosis is reflected in circulating leukocytes by different parameters, like differential mRNA expression and an increased fragmentation of the DNA. Such alterations point out a relationship between cellular stress and apoptotic events. Based on the results of mRNA-expression the investigators also expect alterations on the protein level. This study is, therefore, designed to characterize the proteome related to the proteins involved in cell death related pathways. Thus, the expression pattern of several proteins in leukocytes from patients with primary open angle glaucoma will be analyzed by techniques like Western-blot and tandem mass spectrometry. These samples will be compared with samples from healthy controls. In addition, they will also be compared with samples from patients with Alzheimer's disease. Since glaucoma is a neurodegenerative disease, these patients will be included as positive controls in this study. |
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Detailed Description | Hypothesis: Differences in the proteome concerning cell death pathways of glaucoma patients correspond to the differences in the mRNA expression of these patients. Specific aims: Characterization of the cellular proteome from human leukocytes of glaucoma patients compared to healthy controls and patients with Alzheimer's disease. Background: Glaucoma is a worldwide leading cause of blindness. The key feature of this ocular neuropathy is characterized by an excavating optic nerve head. Loss of retinal ganglion cells is the final end point in blinding diseases of the optic nerve such as glaucoma. It is known that neuronal cell death in glaucoma occurs by an apoptotic mechanism. In earlier studies we could demonstrate that this cell death is reflected in circulating leukocytes by different parameters, like differential mRNA expression, and an increased fragmentation of the DNA. The differences in mRNA expression indicate a close relationship to cellular stress conditions and apoptotic events: increased mRNA expression was detected for p53, 20S proteasome alpha subunit, ABC1 transporter, p21(WAF1/CIP1), 14-3-3 sigma factor, MMP-9 and MMP-14, and TIMP-1. Based on the assumption that glaucoma patients may differ on the level of their expression for these mRNAs, we expect that similar differences should exist at the protein level. This study is, therefore, designed to characterize the proteome related to the proteins involved in cell death related pathways. |
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Study Phase | |||||
Study Type † | Observational | ||||
Study Design † | Case-Only, Prospective | ||||
Condition † |
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Intervention † | |||||
Study Arms / Comparison Groups |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Estimated Enrollment † | 80 | ||||
Estimated Completion Date | September 2011 | ||||
Estimated Primary Completion Date | May 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria: Any history of:
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Gender | Both | ||||
Ages | 18 Years to 75 Years | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts †† |
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Location Countries † | Switzerland | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00691340 | ||||
Responsible Party | Selim Orgül, MD, University Hospital, Basel, Switzerland | ||||
Secondary IDs †† | |||||
Study Sponsor † | University Hospital, Basel, Switzerland | ||||
Collaborators †† | University Hospital, Bonn | ||||
Investigators † |
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Information Provided By | University Hospital, Basel, Switzerland | ||||
Verification Date | February 2009 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |