Eye DiseasesBioBankNCT01240343
Creation of the Biobank Related to Eye Disease
An observational study of Eye Diseases, run by Kimberly Drenser at 1 site in United States.
Trial summary
The purpose of this study is to develop a BioBank (a specialized lab) and collect blood, fluids and/or other tissue samples to study eye diseases. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Eye Diseases
- How many people
- 669 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to 4 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: All pediatric and adult patients (age 0-99)who are being seen in the eye Dr. office and or having eye surgery
Inclusion Criteria: All pediatric and adult patients age 0-99 years -
Exclusion Criteria: All patients who do not agree to consent for collection of blood, fluids, tissue.
Patients who are cognitively impaired and are not able to verbalize understanding of the risks/benefits.
-
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
The purpose of this study is to develop a BioBank (a specialized lab) and collect blood, fluids and/or other tissue samples to study eye diseases.
Read the detailed description
The purpose of the Biobank related to eye disease at Beaumont Hospital is to help connect specialties and Specialists with each other, outside traditional limits of hospital or laboratory departments. The specimens (blood, fluids, and/or tissue samples) that will be collected from men, women and children will assist the researchers in a variety of studies on human eye diseases.
Research utilizing these specimens will allow for an increased understanding of the etiology, disease process, and response to treatments for various eye diseases, and will provide opportunities to subsequently improve our management decisions. Furthermore, projects that cross over between subspecialties are sparse and that is a limiting factor for the development of research that takes a more comprehensive approach.
- Conditions
- Eye Diseases
- Keywords
- Biobank, Genetics
- Medical subject headings
- Eye Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
To build the platform for a novel application of translational research that links cutting edge molecular laboratory techniques to clinical outcome studies
Biobanks can be used for numberous discovery applications such as: identification and structural characterization of human genes, expression analysis, or discovery proteomics. Biological specimens, when coupled with standardized treatment and outcome data, will be essential resources for the identification, characterization and validation of biomarkers that are predictive of disease and treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2010 (estimated)
- Study startJun 2009
- Primary completion4 Dec 2017
- Study completion4 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 669 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kimberly Drenser
- Sponsor type
- University, hospital or other
- Collaborators
- Vision Research Foundation
- Responsible party
- Sponsor-investigator, Kimberly Drenser, Corewell Health East
- Investigators
- Kimberly Drenser, MD, PhD, Principal investigator, Associated Retinal Consultants, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01240343
- Sponsor's protocol ID
- 2009-057
- Acronym
- BioBank
- Status last verified
- Jan 2018
- First submitted
- 10 Nov 2010
- Last updated
- 11 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share at this time
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of the Biobank Related to Eye Disease
- ClinicalTrials.gov ID
- NCT01240343
- Acronym / sponsor ID
- BioBank / 2009-057
- Conditions
- Eye Diseases
- Keywords
- Biobank, Genetics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 669 participants (actual)
- Lead sponsor
- Kimberly DrenserUniversity, hospital or other
- Collaborators
- Vision Research Foundation
- Study start
- Jun 2009
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 4 Dec 2017 (actual)
- First posted
- 15 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop a BioBank (a specialized lab) and collect blood, fluids and/or other tissue samples to study eye diseases.
Detailed description
The purpose of the Biobank related to eye disease at Beaumont Hospital is to help connect specialties and Specialists with each other, outside traditional limits of hospital or laboratory departments. The specimens (blood, fluids, and/or tissue samples) that will be collected from men, women and children will assist the researchers in a variety of studies on human eye diseases.
Research utilizing these specimens will allow for an increased understanding of the etiology, disease process, and response to treatments for various eye diseases, and will provide opportunities to subsequently improve our management decisions. Furthermore, projects that cross over between subspecialties are sparse and that is a limiting factor for the development of research that takes a more comprehensive approach.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All pediatric and adult patients (age 0-99)who are being seen in the eye Dr. office and or having eye surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To build the platform for a novel application of translational research that links cutting edge molecular laboratory techniques to clinical outcome studies
Biobanks can be used for numberous discovery applications such as: identification and structural characterization of human genes, expression analysis, or discovery proteomics. Biological specimens, when coupled with standardized treatment and outcome data, will be essential resources for the identification, characterization and validation of biomarkers that are predictive of disease and treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2018.
- Individual participant dataSharing planned: No. No plan to share at this time
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kimberly Drenser, MD, PhD principal investigator
Associated Retinal Consultants, P.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Diseases, run by Kimberly Drenser at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To build the platform for a novel application of translational research that links cutting edge molecular laboratory techniques to clinical outcome studies. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2018.