Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium
| Tracking Information | |||||||||||||||||
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| First Received Date ICMJE | February 12, 2010 | ||||||||||||||||
| Last Updated Date | January 30, 2013 | ||||||||||||||||
| Start Date ICMJE | March 2010 | ||||||||||||||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
biomarkers [ Time Frame: 12 months ] [ Designated as safety issue: No ] 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 |
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| Original Primary Outcome Measures ICMJE |
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. [ Time Frame: 2 futher visits at 6 months and 12 months after surgery ] [ Designated as safety issue: No ] | ||||||||||||||||
| Change History | Complete list of historical versions of study NCT01068496 on ClinicalTrials.gov Archive Site | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium | ||||||||||||||||
| Official Title ICMJE | Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium | ||||||||||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||||||||||
| Biospecimen | Retention: Samples With DNA Description: Pterygium and conjunctival tissue samples |
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| Sampling Method | Non-Probability Sample | ||||||||||||||||
| 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. |
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| Condition ICMJE | Pterygium | ||||||||||||||||
| Intervention ICMJE | Not Provided | ||||||||||||||||
| Study Group/Cohort (s) | Not Provided | ||||||||||||||||
| Publications * | Not Provided | ||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||||||||||
| Estimated Enrollment ICMJE | 100 | ||||||||||||||||
| Estimated Completion Date | December 2014 | ||||||||||||||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | 21 Years and older | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Singapore | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT01068496 | ||||||||||||||||
| Other Study ID Numbers ICMJE | R707/57/2009 | ||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||
| Responsible Party | Louis Tong, Singapore National Eye Centre | ||||||||||||||||
| Study Sponsor ICMJE | Singapore National Eye Centre | ||||||||||||||||
| Collaborators ICMJE | Singapore Eye Research Institute | ||||||||||||||||
| Investigators ICMJE |
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| Information Provided By | Singapore National Eye Centre | ||||||||||||||||
| Verification Date | January 2013 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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