Creation of the Biobank Related to Eye Disease | NCT01240343

Studies
Creation of the Biobank Related to Eye Disease

NCT01240343

Sponsor

Kimberly Drenser

Status

Completed

Last Update Posted

Jan 11, 2018Actual

Enrollment

669Actual

Phase

Not provided

Conditions

Eye Diseases

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 4, 2017Actual

Completion Date

Dec 4, 2017Actual

First Submitted Date

Nov 10, 2010

First Submission Date that Met QC Criteria

Nov 10, 2010

First Posted Date

Nov 15, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 10, 2018

Last Update Posted Date

Jan 11, 2018Actual

Name	Class
Vision Research Foundation	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

669Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder 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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Kimberly Drenser, MD, PhD	Associated Retinal Consultants, P.C.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
William Beaumont Hospital		Royal Oak	Michigan	48073	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

No plan to share at this time

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005128	Eye Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided