Conjunctival NeoplasmsNCT03515954
AS-OCT Guided Treatment of Diffuse CSCC
An observational study of Conjunctival Neoplasms, run by Benha University.
Trial summary
A prospective study was performed on 8 eyes of 8 patients who underwent amniotic membrane graft after diffuse conjunctival squamous cell neoplasia excision followed by topical mitomycin C 0.04% eye drop between March 2014 and January 2018. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Conjunctival Neoplasms
- What is being tested?
- Treatment of diffuse ocular surface squamous neoplasia
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Mar 2014to Oct 2018
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This study included 8 eyes of 8 patients. The mean age of all patients was 51.9 ± 9.9 years. There were 7 males (87.5%) and 1 female (12.5%).
Who may be able to join
- diffuse Ocular Surface Squamous Neoplasia
Who cannot join
- localized OSSN (less than five clock hours in limbal extent)
About this study
Official title: Anterior Segment Optical Coherence Tomography (AS-OCT) Guided Treatment of Diffuse Conjunctival Squamous Cell Carcinoma (CSCC) With Excision, Amniotic Membrane Graft Using Fibrin Glue and Topical Mitomycin C (MMC)
A prospective study was performed on 8 eyes of 8 patients who underwent amniotic membrane graft after diffuse conjunctival squamous cell neoplasia excision followed by topical mitomycin C 0.04% eye drop between March 2014 and January 2018.
Read the detailed description
Surgical excision of the conjunctival tumour . A superficial corneal scraping was performed for corneal lesion then double freeze-thaw cryotherapy was applied to limbal edge and conjunctival margins.The amniotic membrane graft was secure and attached to the sclera and conjunctiva using fibrin glue.Topical mitomycin C 0.04%eye drop was prescribed 4 times daily per treatment cycle (1 cycle=1 week on 1 week off).
- Conditions
- Conjunctival Neoplasms
- Being tested
- Treatment of diffuse ocular surface squamous neoplasia
- Keywords
- conjunctiva, squamous neoplasia, amniotic
- Medical subject headings
- Conjunctival Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment of diffuse ocular surface squamous neoplasiaProcedure or surgery
Excision of the conjunctival tumour was done.Amniotic membrane was secured into conjunctival defects. Postoperative topical MMC 0.04% was given. Response to treatment was monitored clinically and by AS-OCT.
What is being measured
The primary outcome is the main question the study is designed to answer.
The recurrence rate of lesion
Any recurrence which is detected clinically or/and by AS-OCT
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2018
- Study startMar 2014
- Primary completionJan 2018
- Study completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conjunctival NeoplasmsStudies 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515954
- Sponsor's protocol ID
- benha19992
- Status last verified
- Dec 2018
- First submitted
- 24 Apr 2018
- Last updated
- 2 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Segment Optical Coherence Tomography (AS-OCT) Guided Treatment of Diffuse Conjunctival Squamous Cell Carcinoma (CSCC) With Excision, Amniotic Membrane Graft Using Fibrin Glue and Topical Mitomycin C (MMC)
- ClinicalTrials.gov ID
- NCT03515954
- Acronym / sponsor ID
- benha19992
- Conditions
- Conjunctival Neoplasms
- Keywords
- conjunctiva, squamous neoplasia, amniotic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Mar 2014 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Oct 2018 (actual)
- First posted
- 4 May 2018 (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.
A prospective study was performed on 8 eyes of 8 patients who underwent amniotic membrane graft after diffuse conjunctival squamous cell neoplasia excision followed by topical mitomycin C 0.04% eye drop between March 2014 and January 2018.
Detailed description
Surgical excision of the conjunctival tumour . A superficial corneal scraping was performed for corneal lesion then double freeze-thaw cryotherapy was applied to limbal edge and conjunctival margins.The amniotic membrane graft was secure and attached to the sclera and conjunctiva using fibrin glue.Topical mitomycin C 0.04%eye drop was prescribed 4 times daily per treatment cycle (1 cycle=1 week on 1 week off).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study included 8 eyes of 8 patients. The mean age of all patients was 51.9 ± 9.9 years. There were 7 males (87.5%) and 1 female (12.5%).
Key inclusion criteria (1 listed)
- diffuse Ocular Surface Squamous Neoplasia
Key exclusion criteria (1 listed)
- localized OSSN (less than five clock hours in limbal extent)
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 |
|---|---|---|
| Treatment of diffuse ocular surface squamous neoplasiaExcision of the conjunctival tumour was done.Amniotic membrane was secured into conjunctival defects. Postoperative topical MMC 0.04% was given. Response to treatment was monitored clinically and by AS-OCT. | Procedure or surgery | – |
Primary outcome
The recurrence rate of lesion
Time frame: 2 years
Any recurrence which is detected clinically or/and by AS-OCT
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 2 Jan 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Conjunctival Neoplasms, run by Benha University.
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 1 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: finished, as of the sponsor's last update on 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The recurrence rate of lesion (time frame: 2 years). 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 2 Jan 2019.