Human Papilloma Virus InfectionNCT04117386
Prevalence of HPV-associated Eye Infection and Cytokine Levels in Tears From Patients Diagnosed With Pterygium
An observational study of Human Papilloma Virus Infection and Pterygium, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Prevalence of HPV-associated eye infection and cytokine levels in tears from patients diagnosed with pterygium Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Human Papilloma Virus Infection, Pterygium
- What is being tested?
- HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong) and Bio-Plex® 200 system (Bio- Rad, Hercules, CA)
- How many people
- 141 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2020to 15 Jun 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Population:Patients diagnosed with primary pterygium and recurrent pterygium Target Population: Patients diagnosed with primary pterygium at out-patient clinic, Department of Ophthalmology, King Chulalongkorn Memorial Hospital Control Population: participants without any ocular diseases
Who may be able to join
- Age above 18 years old
- presence of pterygium invading the cornea
Who cannot join
- Other ocular inflammation that could affect the results of the study (such as conjunctivitis, keratitis, conjunctival tumor, etc) or would preclude the enrollment for safety reasons
- Participant without ocular disease Inclusion criteria
- Age above 18 years old Exclusion criteria
- Presence of any ocular inflammation diseases
Trial locations and contacts
1 site in 1 country.
About this study
Prevalence of HPV-associated eye infection and cytokine levels in tears from patients diagnosed with pterygium
Read the detailed description
The main purpose of this study is to evaluate the prevalence of HPV infection in primary and recurrent pterygium and the association of HPV types collecting from conjunctiva swab and urine. The second purpose is to compare a quantity of cytokines including IL-6, IL-18 and growth factor including VEGF found in tears of patients with primary and recurrent pterygium to participants with free of ocular disease Primary hypothesis
- The prevalence of HPV infection in primary pterygium is difference with prevalence in recurrent pterygium patients.
Secondary hypothesis
- Ocular HPV infection has association with HPV genitalia infection.
- Tears cytokine and growth factor level (IL-6, IL-18 and VEGF) are higher in pterygium HPV infection than non-HPV infection and also more than normal population
- Conditions
- Human Papilloma Virus Infection, Pterygium
- Being tested
- HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong), Bio-Plex® 200 system (Bio- Rad, Hercules, CA)
- Keywords
- HPV infection, Pterygium, Cytokine, VEGF, auto-inoculation
- Medical subject headings
- Papillomavirus Infections, Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong)Diagnostic test
HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong) for swab sample collected from pterygium and normal conjunctiva and also for urine collected in Colli-PeeTM device (Novosanis, Belgium)
Bio-Plex® 200 system (Bio- Rad, Hercules, CA)Diagnostic test
Bioplex was use for measure cytokine IL-6, IL-18 and VEGF from tears collected from Schirmer strip
| Study group | Role | What they receive |
|---|---|---|
| Primary pterygium group | Participants who was diagnosed with primary pterygium Receives: Diagnostic Test: HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong); Diagnostic Test: Bio-Plex® 200 system (Bio- Rad, Hercules, CA) | |
| Secondary pterygium group | Participants who was diagnosed with secondary pterygium Receives: Diagnostic Test: HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong); Diagnostic Test: Bio-Plex® 200 system (Bio- Rad, Hercules, CA) | |
| Healthy participants as control group | Participants who have no pterygium and other inflammation disease in eyes Receives: Diagnostic Test: HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong); Diagnostic Test: Bio-Plex® 200 system (Bio- Rad, Hercules, CA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPV prevalence
- To compare HPV prevalence in subjects with primary pterygium and with recurrent pterygium
Measured: 1 hour per participants which is on a day for collecting sample
Secondary outcomes (2)
HPV autoinoculation
To assess whether HPV autoinoculation is present, we evaluate whether there is an association between HPV ocular infection and genital infection.
Measured: 1 hour per participants which is on a day for collecting sample
cytokine IL-6, IL-18 and VEGF levels
To compare cytokine IL-6, IL-18 and VEGF levels among various subgroups, including recurrent pterygium subjects with HPV positive and HPV negative status, primary pterygium subjects with HPV positive and HPV negative, and subjects without ocular diseases
Measured: 1 hour per participants which is on a day for collecting sample
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2019
- Study start1 Jan 2020
- Primary completion30 Apr 2020
- Study completion15 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma Virus InfectionStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ngamjit Kasetsuwan, Chulalongkorn University
- Investigators
- Ngamjit Kasetsuwan, Principal investigator, Department of Ophthalmology, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04117386
- Sponsor's protocol ID
- IRB NO. 405/62
- Status last verified
- Jul 2020
- First submitted
- 3 Oct 2019
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: If there is anybody contacting our team for data in the purpose of future research, we agree to share our data.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of HPV-associated Eye Infection and Cytokine Levels in Tears From Patients Diagnosed With Pterygium
- ClinicalTrials.gov ID
- NCT04117386
- Acronym / sponsor ID
- IRB NO. 405/62
- Conditions
- Human Papilloma Virus Infection, Pterygium
- Keywords
- HPV infection, Pterygium, Cytokine, VEGF, auto-inoculation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Apr 2020 (actual)
- Study completion
- 15 Jun 2020 (actual)
- First posted
- 7 Oct 2019 (actual)
- 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.
Prevalence of HPV-associated eye infection and cytokine levels in tears from patients diagnosed with pterygium
Detailed description
The main purpose of this study is to evaluate the prevalence of HPV infection in primary and recurrent pterygium and the association of HPV types collecting from conjunctiva swab and urine. The second purpose is to compare a quantity of cytokines including IL-6, IL-18 and growth factor including VEGF found in tears of patients with primary and recurrent pterygium to participants with free of ocular disease Primary hypothesis
- The prevalence of HPV infection in primary pterygium is difference with prevalence in recurrent pterygium patients.
Secondary hypothesis
- Ocular HPV infection has association with HPV genitalia infection.
- Tears cytokine and growth factor level (IL-6, IL-18 and VEGF) are higher in pterygium HPV infection than non-HPV infection and also more than normal population
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Primary pterygium group | – | Diagnostic Test: HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong), Diagnostic Test: Bio-Plex® 200 system (Bio- Rad, Hercules, CA)Participants who was diagnosed with primary pterygium |
| Secondary pterygium group | – | Diagnostic Test: HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong), Diagnostic Test: Bio-Plex® 200 system (Bio- Rad, Hercules, CA)Participants who was diagnosed with secondary pterygium |
| Healthy participants as control group | – | Diagnostic Test: HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong), Diagnostic Test: Bio-Plex® 200 system (Bio- Rad, Hercules, CA)Participants who have no pterygium and other inflammation disease in eyes |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Population:Patients diagnosed with primary pterygium and recurrent pterygium Target Population: Patients diagnosed with primary pterygium at out-patient clinic, Department of Ophthalmology, King Chulalongkorn Memorial Hospital Control Population: participants without any ocular diseases
Key inclusion criteria (2 listed)
- Age above 18 years old
- presence of pterygium invading the cornea
Key exclusion criteria (4 listed)
- Other ocular inflammation that could affect the results of the study (such as conjunctivitis, keratitis, conjunctival tumor, etc) or would preclude the enrollment for safety reasons
- Participant without ocular disease Inclusion criteria
- Age above 18 years old Exclusion criteria
- Presence of any ocular inflammation diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong)HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong) for swab sample collected from pterygium and normal conjunctiva and also for urine collected in Colli-PeeTM device (Novosanis, Belgium) | Diagnostic test | Healthy participants as control group, Primary pterygium group, Secondary pterygium group |
| Bio-Plex® 200 system (Bio- Rad, Hercules, CA)Bioplex was use for measure cytokine IL-6, IL-18 and VEGF from tears collected from Schirmer strip | Diagnostic test | Healthy participants as control group, Primary pterygium group, Secondary pterygium group |
Primary outcome
HPV prevalence
Time frame: 1 hour per participants which is on a day for collecting sample
1. To compare HPV prevalence in subjects with primary pterygium and with recurrent pterygium
2 secondary outcomes
HPV autoinoculation
Time frame: 1 hour per participants which is on a day for collecting sample
cytokine IL-6, IL-18 and VEGF levels
Time frame: 1 hour per participants which is on a day for collecting sample
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Individual participant dataSharing planned: Yes. If there is anybody contacting our team for data in the purpose of future research, we agree to share our data.
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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.
Ngamjit Kasetsuwan principal investigator
Department of Ophthalmology, Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papilloma Virus Infection and Pterygium, run by Chulalongkorn University at 1 site in Thailand.
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 2 inclusion and 4 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: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
HPV prevalence (time frame: 1 hour per participants which is on a day for collecting sample). 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 14 Jul 2020.