PterygiumNCT06042296
Expression of CD44, PCNA and E-cadherin in Pterygium Tissue
An observational study of Pterygium, run by Balikesir University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: Pterygium is a common ocular surface disease defined by fibrovascular conjunctival growth extending onto the cornea. Its pathogenesis remains unclear. In severe cases, it may extend into the central cornea, inducing irregular corneal astigmatism and causing loss of vision. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pterygium
- What is being tested?
- Expression of CD44, E-cadherin and PCNA
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2023to Jan 2024
- How long will I take part?
- 4 Months
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: 60 patient with primary and recurrent pterygium
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hümeyra Yildirim
Balıkesir, 10100
HÜMEYRA YILDIRIM, 905305244841, balikesirhumeyra@gmail.com
About this study
Purpose: Pterygium is a common ocular surface disease defined by fibrovascular conjunctival growth extending onto the cornea. Its pathogenesis remains unclear. In severe cases, it may extend into the central cornea, inducing irregular corneal astigmatism and causing loss of vision. CD44( phagocytic glycoprotein-1 ) is involved in the organization of certain cellular processes, for instance, cell adhesion, division, and migration, by binding with its main ligand, hyaluronic acid. Proliferating cell nuclear antigen (PCNA) is a proliferation marker in the nucleus. E-cadherin is a calcium-dependent transmembrane glycoprotein that plays a significant role in the protection of tissue integrity and cell-to-cell adhesion. This study aimed to determine the role of CD44, proliferating cell nuclear antigen (PCNA), and E-cadherin in pterygium formation and recurrence.
Read the detailed description
Methods:60 patients with pterygium will be enrolled in the study and conjunctival samples will be collected from 30 patients to form the control group. CD44, PCNA and E-cadherin expressions in surgically removed pterygium will be compared with tissue samples from normal control group.
IBM SPSS (statistical software) version 26.0 will be used for statistical analyses.
- Conditions
- Pterygium
- Being tested
- Expression of CD44, E-cadherin and PCNA
- Keywords
- PCNA,, cd44, e-cadherin, immunohistochemistry, pterygium
- Medical subject headings
- Pterygium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expression of CD44, E-cadherin and PCNAOther
The investigators use primary antibodies against CD44 (1:50 dilution) and E-cadherin (1:200 dilution), and a human monoclonal antibody against PCNA (1:100 dilution) for antigen retrieval. Histopathological and immunohistochemical staining findings will be reported using a Nikon light microscope and an image analysis system (Nikon Instruments Europe BV)
| Study group | Role | What they receive |
|---|---|---|
| control group | group 1 -control group normal conjunctiva from 30 patients Receives: Other: Expression of CD44, E-cadherin and PCNA | |
| group 2 primary pterygia | primary pterygia samples from 30 patients Receives: Other: Expression of CD44, E-cadherin and PCNA | |
| group 3 recurrent pterygia | recurrent pterygia samples from 30 patients Receives: Other: Expression of CD44, E-cadherin and PCNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunohistochemistry
Thin sections will be taken from paraffin embedded tissue samples and placed on barcode glass slides After deparaffinization and rehydration, the sections will be subjected to histopathological evaluation using hematoxylin and eosin staining.We use primary antibodies against CD44 (1:50 dilution) and E-cadherin (1:200 dilution), and a human monoclonal antibody against PCNA (1:100 dilution) for antigen retrieval
Measured: up to three weeks after pterygium surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study startOct 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionJan 2024 (estimated)
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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Balikesir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HUMEYRA YILDIRIM, Balikesir University
- Investigators
- HÜMEYRA YILDIRIM, Principal investigator, Balıkesir Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042296
- Sponsor's protocol ID
- BAUNHYILDIRIM-1
- Status last verified
- Sep 2023
- First submitted
- 10 Sep 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of CD44, PCNA and E-cadherin in Pterygium Tissue
- ClinicalTrials.gov ID
- NCT06042296
- Acronym / sponsor ID
- BAUNHYILDIRIM-1
- Conditions
- Pterygium
- Keywords
- PCNA,, cd44, e-cadherin, immunohistochemistry, pterygium
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Balikesir UniversityUniversity, hospital or other
- Study start
- Oct 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 18 Sep 2023 (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.
Purpose: Pterygium is a common ocular surface disease defined by fibrovascular conjunctival growth extending onto the cornea. Its pathogenesis remains unclear. In severe cases, it may extend into the central cornea, inducing irregular corneal astigmatism and causing loss of vision. CD44( phagocytic glycoprotein-1 ) is involved in the organization of certain cellular processes, for instance, cell adhesion, division, and migration, by binding with its main ligand, hyaluronic acid. Proliferating cell nuclear antigen (PCNA) is a proliferation marker in the nucleus. E-cadherin is a calcium-dependent transmembrane glycoprotein that plays a significant role in the protection of tissue integrity and cell-to-cell adhesion. This study aimed to determine the role of CD44, proliferating cell nuclear antigen (PCNA), and E-cadherin in pterygium formation and recurrence.
Detailed description
Methods:60 patients with pterygium will be enrolled in the study and conjunctival samples will be collected from 30 patients to form the control group. CD44, PCNA and E-cadherin expressions in surgically removed pterygium will be compared with tissue samples from normal control group.
IBM SPSS (statistical software) version 26.0 will be used for statistical analyses.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control group | – | Other: Expression of CD44, E-cadherin and PCNAgroup 1 -control group normal conjunctiva from 30 patients |
| group 2 primary pterygia | – | Other: Expression of CD44, E-cadherin and PCNAprimary pterygia samples from 30 patients |
| group 3 recurrent pterygia | – | Other: Expression of CD44, E-cadherin and PCNArecurrent pterygia samples from 30 patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 60 patient with primary and recurrent pterygium
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Expression of CD44, E-cadherin and PCNAThe investigators use primary antibodies against CD44 (1:50 dilution) and E-cadherin (1:200 dilution), and a human monoclonal antibody against PCNA (1:100 dilution) for antigen retrieval. Histopathological and immunohistochemical staining findings will be reported using a Nikon light microscope and an image analysis system (Nikon Instruments Europe BV) | Other | control group, group 2 primary pterygia, group 3 recurrent pterygia |
Primary outcome
Immunohistochemistry
Time frame: up to three weeks after pterygium surgery
Thin sections will be taken from paraffin embedded tissue samples and placed on barcode glass slides After deparaffinization and rehydration, the sections will be subjected to histopathological evaluation using hematoxylin and eosin staining.We use primary antibodies against CD44 (1:50 dilution) and E-cadherin (1:200 dilution), and a human monoclonal antibody against PCNA (1:100 dilution) for antigen retrieval
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No
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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.
HÜMEYRA YILDIRIM principal investigator
Balıkesir Medical Faculty
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 Pterygium, run by Balikesir University at 1 site in Turkey (Türkiye).
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 0 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 18 Sep 2023. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact HÜMEYRA YILDIRIM (05305244841, balikesirhumeyra@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immunohistochemistry (time frame: up to three weeks after pterygium surgery). 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 18 Sep 2023.