PterygiumNCT01068496
Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium
An observational study of Pterygium, run by Singapore National Eye Centre at 2 sites in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Pterygium
- How many people
- 1 participants
- Where
- 2 sitesSingapore
- Study dates
- Mar 2010to Dec 2014
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older 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.
Who may be able to join
- Clinical diagnosis of primary and recurrence pterygium
- Must agree to participate in this study
- Must sign informed consent form
Who cannot join
- Hepatitis
- HIV/AIDS
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Singapore National Eye Centre
Singapore, Singapore, 168571
Singapore National Eye Center
Singapore, 168751
About this study
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.
Read the 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.
- Conditions
- Pterygium
- Medical subject headings
- Pterygium
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2010 (estimated)
- Study startMar 2010
- Primary completionDec 2014
- Study completionDec 2014
Why it stopped: Other and future studies on lipiview in pterygium will cover this current trial sufficiently.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PterygiumStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Collaborators
- Singapore Eye Research Institute
- Responsible party
- Principal investigator, Louis Tong, Singapore National Eye Centre
- Investigators
- Samanthila Waduthantri, Study chair, Singapore National Eye CentreLaurence Lim, MBBS, Study chair, Singapore National Eye CentreFederico Luengo Gimeno, Study chair, Singapore National Eye CentreJodhbir Mehta, Study chair, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068496
- Sponsor's protocol ID
- R707/57/2009
- Status last verified
- Jan 2013
- First submitted
- 12 Feb 2010
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors and Biomarkers Associated With Recurrence After Excision of Primary Pterygium
- ClinicalTrials.gov ID
- NCT01068496
- Acronym / sponsor ID
- R707/57/2009
- Conditions
- Pterygium
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Other and future studies on lipiview in pterygium will cover this current trial sufficiently.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Singapore National Eye CentreOther government
- Collaborators
- Singapore Eye Research Institute
- Study start
- Mar 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 15 Feb 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (3 listed)
- Clinical diagnosis of primary and recurrence pterygium
- Must agree to participate in this study
- Must sign informed consent form
Key exclusion criteria (2 listed)
- Hepatitis
- HIV/AIDS
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
biomarkers
Time frame: 12 months
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
Results and safety
The study was stopped early (reason given: Other and future studies on lipiview in pterygium will cover this current trial sufficiently.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
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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.
Samanthila Waduthantri study chair
Singapore National Eye Centre
Laurence Lim, MBBS study chair
Singapore National Eye Centre
Federico Luengo Gimeno study chair
Singapore National Eye Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pterygium, run by Singapore National Eye Centre at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. 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 was stopped early (reason given: Other and future studies on lipiview in pterygium will cover this current trial sufficiently.). Results are not available in the source record.
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?
biomarkers (time frame: 12 months). 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 20 May 2015.