Risk Factors and Biomarkers Associated With Recurrence Af... | NCT01068496

Studies
Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium

NCT01068496

Sponsor

Singapore National Eye Centre

Status

Terminated

Last Update Posted

May 20, 2015Estimated

Enrollment

1Actual

Phase

Not provided

Conditions

Pterygium

Interventions

Not provided

Countries

Singapore

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 2013

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Other and future studies on lipiview in pterygium will cover this current trial sufficiently.

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

Feb 12, 2010

First Submission Date that Met QC Criteria

Feb 12, 2010

First Posted Date

Feb 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

May 18, 2015

Last Update Posted Date

May 20, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Louis Tong, Singapore National Eye Centre, Singapore National Eye CentrePrincipal Investigator

Lead Sponsor

Singapore National Eye CentreOTHER_GOV

Collaborators

Name	Class
Singapore Eye Research Institute	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

This study looks at global gene expression in pterygium and found the derangement of matrix genes in particular to be a feature of pterygium. In the investigators opinion, it would be more beneficial to elicit changes in gene expression before the recurrence of pterygium and by developing a panel of biomarkers that are associated with pterygium recurrence; one would be able to predict the post surgical prognosis of patients after resection.Biomarker levels will be compared to discover a biomarker panel for prediction of recurrence.

Detailed Description

A comprehensive questionnaire will be used to evaluate the environmental, biological, physical and behavioral risk factors of associated with the recurrence after pterygium excision.

Slit lamp digital color photographs will be taken on primary and recurrent pterygium and pterygium will be graded in three levels of severity, based on relative transparency of pterygium tissue; grade 1 (transparent), grade 2 (intermediate), and grade 3 (opaque) to see whether the risk factors correlate to the morphology of the pterygium.

Tear samples will be collected before surgery using schirmers strip.Proteins in tear samples will be analyzed using the iTRAQ method.

The transcriptional differences in pterygium and conjunctival tissue samples will be analyzed using western blot, qPCR and immunohistochemistry assays.

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

1Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
biomarkers	Elevation of biomarkers in pterygium tissue and tears (transcripts, proteins, or tear proteins) at the time of initial presentation of primary pterygium may predict the post-surgical recurrence within one year. visits: 2 further visits at 6 months and 12 months after surgery	12 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of primary and recurrence pterygium
Must agree to participate in this study
Must sign informed consent form

Exclusion Criteria:

Hepatitis
HIV/AIDS

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Pterygium patients from the investigator's clinic as well as other clinics at the Singapore National Eye Center will be recruited for this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Samanthila Waduthantri	Singapore National Eye Centre	Study Chair
Laurence Lim, MBBS	Singapore National Eye Centre	Study Chair
Federico Luengo Gimeno	Singapore National Eye Centre	Study Chair
Jodhbir Mehta	Singapore National Eye Centre	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Singapore National Eye Centre		Singapore	Singapore	168571	Singapore
Singapore National Eye Center

Condition Browse Module

MeSH Terms

ID	Term
D011625	Pterygium

Ancestor Terms

ID	Term
D003229	Conjunctival Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided