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Trial registered on ANZCTR


Registration number
ACTRN12611000821998
Ethics application status
Not yet submitted
Date submitted
2/08/2011
Date registered
4/08/2011
Date last updated
4/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Periocular Squamous Cell Carcinoma – An International Multicentre Review
Scientific title
A retrospective, multicentre, observational case series to review the clinical features, management, pathology and outcomes of periocular squamous cell carcinoma (SCC)
Secondary ID [1] 262761 0
'Nil'
Universal Trial Number (UTN)
U1111-1123-3745
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periocular Squamous Cell Carcinoma 270472 0
Condition category
Condition code
Eye 270626 270626 0 0
Diseases / disorders of the eye
Cancer 270628 270628 0 0
Other cancer types
Skin 270629 270629 0 0
Other skin conditions

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Retrospective review of an observational case series. To specifically look for clinical or histologic features that may correlate with lymph node metastasis, distant metastasis and death. To assess the prevalence of high risk periocular SCC treated in tertiary referral oculoplastic centres.
Method: Review of subject's hospital medical recrods
from January 2000 to January 2001.
Intervention code [1] 267112 0
Not applicable
Comparator / control treatment
'Nil'
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269354 0
Time to local recurrence,
Timepoint [1] 269354 0
Review of data over a 12 month period
Primary outcome [2] 269356 0
time to regional and distant metastasis
Timepoint [2] 269356 0
Review of data over a 12 month period
Secondary outcome [1] 279441 0
complications related to treatment and overall survival
Timepoint [1] 279441 0
Review of data over a 12 month period

Eligibility
Key inclusion criteria
Histologically confirmed primary or recurrent cutaneous SCC involving skin within the orbital rim.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Cutaneous SCC arising outside of the periocular region

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4330 0
5000
Recruitment postcode(s) [2] 4331 0
3002
Recruitment postcode(s) [3] 4332 0
4063
Recruitment postcode(s) [4] 4333 0
2065
Recruitment outside Australia
Country [1] 3766 0
United States of America
State/province [1] 3766 0
77030

Funding & Sponsors
Funding source category [1] 269583 0
Hospital
Name [1] 269583 0
Royal Adelaide Hospital
Country [1] 269583 0
Australia
Primary sponsor type
Individual
Name
Dr Adnan Pirbhai
Address
Ophthalmology Network
Level 8 EW
Royal Adelaide Hospital
North Tce
ADELAIDE SA 5000
Country
Australia
Secondary sponsor category [1] 266617 0
Individual
Name [1] 266617 0
Prof Dinesh Selva
Address [1] 266617 0
Ophthalmology Network
Level 8 EW
Royal Adelaide Hospital
North Tce
ADELAIDE SA 5000
Country [1] 266617 0
Australia
Other collaborator category [1] 252163 0
Individual
Name [1] 252163 0
Dr Bita Esmaeli
Address [1] 252163 0
The University of Texas M.D. Anderson Cancer Centre
Section of Ophthalmology
Department of Head and Neck Surgery
Houston, Texas
USA 77030
Country [1] 252163 0
United States of America
Other collaborator category [2] 252164 0
Individual
Name [2] 252164 0
Dr Alan McNab
Address [2] 252164 0
North Shore Medical Centre
Sydney, New South Wales
Australia 2065
Country [2] 252164 0
Australia
Other collaborator category [3] 252165 0
Individual
Name [3] 252165 0
Dr Brett O'Donnell
Address [3] 252165 0
Royal Brisbane and Women?s Hospital
University of Queensland
Brisbane, Queensland
Australia 4063
Country [3] 252165 0
Australia
Other collaborator category [4] 252166 0
Individual
Name [4] 252166 0
Dr Timothy Sullivan
Address [4] 252166 0
Royal Victorian Eye and Ear Hospital
University of Melbourne
Melbourne, Victoria
Australia 3002
Country [4] 252166 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 269536 0
Royal Adelaide Ethics Committee
Ethics committee address [1] 269536 0
Royal Adelaide Hospital
North Tce
Adelaide SA 5000
Ethics committee country [1] 269536 0
Australia
Date submitted for ethics approval [1] 269536 0
03/08/2011
Approval date [1] 269536 0
Ethics approval number [1] 269536 0

Summary
Brief summary
To review the clinical features, management, pathology and outcomes of periocular squamous cell carcinoma (SCC). To specifically look for clinical or histologic features that may correlate with lymph node metastasis, distant metastasis and death. To assess the prevalence of high risk periocular SCC treated in tertiary referral oculoplastic centres.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32966 0
Address 32966 0
Country 32966 0
Phone 32966 0
Fax 32966 0
Email 32966 0
Contact person for public queries
Name 16213 0
Kylie Dansie
Address 16213 0
Ophthalmology Network
Level 8 EW
Royal Adelaide Hospital
North Tce
ADELAIDE SA 5000
Country 16213 0
Australia
Phone 16213 0
61 8 8222 2732
Fax 16213 0
61 8 8222 2741
Email 16213 0
[email protected]
Contact person for scientific queries
Name 7141 0
Adnan Pirbhai
Address 7141 0
Ophthalmology Network
Level 8 EW
Royal Adelaide Hospital
North Tce
ADELAIDE SA 5000
Country 7141 0
Australia
Phone 7141 0
61 8 8222 2732
Fax 7141 0
61 8 8222 2741
Email 7141 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.