Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201912900667480 Date of Registration: 06/12/2019
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Ocular Surface Squamous Neoplasia: Risk factors, diagnosis, management and outcomes at a Tertiary Eye Hospital in South Africa
Official scientific title Ocular Surface Squamous Neoplasia: Risk factors, diagnosis, management and outcomes at a Tertiary Eye Hospital in South Africa
Brief summary describing the background and objectives of the trial The aim of the study is to describe the presentation, diagnosis, management and outcomes of patients with symptomatic conjunctival masses at a tertiary eye hospital in Johannesburg, in a country with a high prevalence of HIV.
Type of trial CCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Cancer,Eye Diseases
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 02/12/2019
Actual trial start date 02/12/2019
Anticipated date of last follow up 30/06/2022
Actual Last follow-up date 31/12/2022
Anticipated target sample size (number of participants) 300
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Surgical excision Once off Surgical excision of a conjunctival mass using a no touch technique for histology. This is used for conjunctival masses that are less than 4 clock hours of the limbus. 100
Experimental Group Topical 5 fluorouracil eye drops 1% four times a day 1 month per cycle Management of conjunctival mass that is greater than 4 limbal clock hours. 5FU cycle, is 1 month 5FU and 1 month drug holiday. Cycles continue for 1 month longer after resolution. 100
Control Group Surgical excision Once off Surgical excision of symptomatic benign lesions, such as pterygiums. 100 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients presenting with symptomatic conjunctival masses that have: 1. Suspicious features of OSSN on clinical examination a. Leukoplakia b. Feeder vessels c. Pigmentation 2. Persistent symptoms despite topical medical therapy a. Redness b. Foreign body sensation c. Blurred vision 1. Age less than 18 years 2. Pregnant or breastfeeding 3. Previous surgery or topical chemotherapy in the presenting eye 4. Masses with invasion of adjacent structures: forniceal conjunctiva, palpebral conjunctiva, tarsal conjunctiva, lacrimal punctum and canaliculi, plica, caruncle, anterior or posterior eyelid lamellae, eyelid margin, and/or intraocular compartments. 5. Neurological conditions that prevent performing study investigations (AS-OCT, IC, methylene blue stain) 6. Heritable conditions that predispose to conjunctival tumours (Xeroderma pigmentosum and oculocutaneous albinism) 7. The presence of primary acquired melanosis 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 90 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 27/11/2019 Human Research Ethics Committee of the University of the Witwatersrand
Ethics Committee Address
Street address City Postal code Country
7 York Rd, Parktown, Johannesburg, 2193 Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome To compare non-invasive diagnostic methods (cytology, AS-OCT, methylene blue staining) with histology (gold standard) in the diagnosis with OSSN To evaluate the outcomes (success and recurrence rates) with OSSN treatment (medical and surgical) over a 1-year period 1 year
Secondary Outcome To identify the characteristics associated with successful OSSN treatment and with OSSN recurrence over a 1-year period To describe the adverse events associated with surgical and medical treatment of OSSN 1 year
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
St John Eye Hospital 26 Chris Hani Road Diepkloof 2013 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Carnegie Fellowship Grant 7 York Rd, Parktown, Johannesburg, 2193 Johannesburg 2193 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor St John Eye Hospital 26 chris road diepkloof 2013 South Africa Hospital
COLLABORATORS
Name Street address City Postal code Country
Roland Hollhumer 7 York Rd, Parktown, Johannesburg, 2193 Johannesburg 2193 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Roland Hollhumer roland.hollhumer@wits.ac.za +27827247207 7 York Rd, Parktown, Johannesburg, 2193
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Lecturer
Role Name Email Phone Street address
Public Enquiries Roland Hollhumer roland.hollhumer@wits.ac.za +27827247207 7 York Rd, Parktown, Johannesburg, 2193
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Lecturer
Role Name Email Phone Street address
Scientific Enquiries Roland Hollhumer roland.hollhumer@wits.ac.za +27827247207 7 York Rd, Parktown, Johannesburg, 2193
City Postal code Country Position/Affiliation
Johannesburg 2193 South Africa Lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All the participant data collected during the trial, after de-identification. Clinical Study Report Data will be shared for 2 years after completion of the final report. Controlled access directly with principle investigator.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information