Search for Biomarkers in Human Glaucoma: Lymphocytes Alte... | NCT00981422

Studies
Search for Biomarkers in Human Glaucoma: Lymphocytes Alterations and Rate of Progression

NCT00981422

Sponsor

University of Parma

Status

Completed

Last Update Posted

Sep 22, 2009Estimated

Enrollment

40Actual

Phase

Not provided

Conditions

Glaucoma, Open-Angle

Interventions

Not provided

Countries

Italy

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

Sep 2009

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 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Jun 2008Actual

First Submitted Date

Sep 21, 2009

First Submission Date that Met QC Criteria

Sep 21, 2009

First Posted Date

Sep 22, 2009Estimated

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

Sep 21, 2009

Last Update Posted Date

Sep 22, 2009Estimated

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 aim of this study was to evaluate the lymphocyte phenotype in primary open- angle glaucoma (POAG) patients compared to healthy subjects of the same age, in order to confirm the importance of immune responses in glaucoma and the possible correlation to the severity of the disease.

Detailed Description

Not provided

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

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Glaucoma patients		POAG patients selected by an ophthalmologist from the Glaucoma Service, Ophthalmology Institute, University of Parma
Healthy		healthy subjects with negative history for (a) neurodegenerative diseases, (b) autoimmune diseases, (c) cancer, (d) viral infection, (e) diabetes, and (f) systemic inflammation

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
compare the lymphocyte phenotype of POAG patients to healthy subjects of the same age		the same day of bloodwithdrawal

Secondary Outcomes

Measure	Description	Time Frame
correlate the immunophenotype of POAG patients to the severity of disease		within 3 months after blood withdrawal

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of primary open-angle glaucoma
age between 19 an 85 years old

Exclusion Criteria:

age less than 19 or more than 85 yrs
positive history for (a) neurodegenerative diseases, (b) autoimmune diseases, (c) cancer, (d) viral infection and (e) diabetes, (f)systemic inflammation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Primary care clinic in Parma (University hospital of Parma)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefano A Gandolfi, MD	Ophthalmology Institute, University of Parma, Italy	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Azienda ospedaliera universitaria		Parma		43100	Italy

Condition Browse Module

MeSH Terms

ID	Term
D005902	Glaucoma, Open-Angle
D005901	Glaucoma

Ancestor Terms

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided