Cellular Proteome From Leukocytes of Glaucoma Patients in Comparison With Patients With Alzheimer's Disease

This study has been withdrawn prior to enrollment.
(was replaced by another study. Problems with recruitment.)
Sponsor:
Collaborator:
University Hospital, Bonn
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00691340
First received: June 3, 2008
Last updated: August 8, 2011
Last verified: August 2011
  Purpose

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.


Condition
Alzheimer's Disease
Glaucoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Systematic Characterization of the Cellular Proteome From Human Leukocytes of Glaucoma Patients in Comparison With Patients With Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Biospecimen Retention:   None Retained

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Estimated Enrollment: 80
Study Start Date: June 2008
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Control 1 (young subjects)
2
Control 2 (old subjects)
3
Glaucoma patients
4
Alzheimer patients

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Glaucoma patients Alzheimer's patients

Criteria

Inclusion Criteria:

  • German native speakers
  • Age between 18-85 years
  • Primary open-angle glaucoma (POAG) with and without vasospasm
  • An inclusion criterion for one control group is Alzheimer's disease.

Exclusion Criteria:

Any history of:

  • Ocular or systemic diseases other than glaucoma or Alzheimer's disease
  • Drug or alcohol abuse
  • Any condition potentially interfering with the visual field results. Visual fields will be obtained from the chart.
  • Mental impairment interfering with the ability to cooperate and understand the purpose of this study.
  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: NCT00691340

Sponsors and Collaborators
University Hospital, Basel, Switzerland
University Hospital, Bonn
Investigators
Study Director: Selim Orguel, MD University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: Selim Orgül, MD, University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT00691340     History of Changes
Other Study ID Numbers: 075-WUK-2008-002
Study First Received: June 3, 2008
Last Updated: August 8, 2011
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
POAG
Alzheimer's disease
cellular proteome
human leucocytes
vasospasm
Healthy subjects

Additional relevant MeSH terms:
Alzheimer Disease
Glaucoma
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Ocular Hypertension
Eye Diseases

ClinicalTrials.gov processed this record on August 20, 2014