Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000542099
Ethics application status
Approved
Date submitted
5/07/2010
Date registered
6/07/2010
Date last updated
19/02/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Growth of skin cancers around the eye – the impact of waiting time for elective surgery.
Scientific title
An observational study to determine the impact of waiting time for elective surgery on the growth rate of skin cancer in patients with periocular basal cell carcinoma.
Secondary ID [1] 252160 0
Nil
Universal Trial Number (UTN)
U1111-1115-9412
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Growth rate of basal cell carcinomas (a type of skin cancer) around the eye whilst patients await elective surgery. 257691 0
Condition category
Condition code
Skin 257865 257865 0 0
Other skin conditions
Cancer 257873 257873 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
We would like to assess how fast basal cell carcinomas grow whilst patients are waiting for surgery on an elective basis.

The possiblities that can occur whilst observing these skin cancers are;
- No change in size
- Increase in size
- Reduction in size

This is an observation of what happens in the public hospital system compared to a private practice. No intervention will be done.

We aim to observe patients over a 9-12 month period.

The observation will be done at baseline and secondly at the time of surgery. The difference in sizes will be documented.
Intervention code [1] 256752 0
Not applicable
Comparator / control treatment
Comparator group are the patients who undergo their surgery at a private practice.

Observation will occur over a 9-12 month period as well.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 258726 0
Primary outcome 1: Rate of basal cell carcinoma growth.

Measurements will be recorded by direct measurement with a ruler after the skin cancer is traced on transparent paper.

The second method will be with photographic measures with digital imaging.
Timepoint [1] 258726 0
Timepoint 1: from baseline (that is, when first seen by a specialist oculoplastic surgeon) and secondly at the time of surgery at the public hospital / private practice.
Secondary outcome [1] 264766 0
Factors that predict fast rate of basal cell carcinoma growth. The factors studied in this trial include:

1: Age
2: Sex
3: Immunosuppression
4: Previous skin cancer
5: Primary vs. recurrent skin cancer
6: Type of basal cell carcinoma

The above factors will be assessed using statistical analysis (correlation analysis) to determine if the above factors are statistically significant.
Timepoint [1] 264766 0
Timepoints for all the above: 9-12 months

It will be assessed at baseline - first specialist appointment with oculoplastic surgeon and secondly at the time of surgery.

Eligibility
Key inclusion criteria
Basal cell carcinomas around the eye.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other types of skin cancers (eg. squamous cell carcinomas) around the eye.

Skin cancers beyond the orbital region.

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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/06/2010
Actual
28/06/2010
Date of last participant enrolment
Anticipated
30/09/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment outside Australia
Country [1] 2742 0
New Zealand
State/province [1] 2742 0
Waikato

Funding & Sponsors
Funding source category [1] 257243 0
Hospital
Name [1] 257243 0
Waikato Hospital
Country [1] 257243 0
New Zealand
Primary sponsor type
Individual
Name
Stephen Ng
Address
Waikato Hospital
Pembroke Street
Hamilton 3204
Waikato
Country
New Zealand
Secondary sponsor category [1] 256486 0
Individual
Name [1] 256486 0
Eugene Tan
Address [1] 256486 0
Skin Centre
171 Cameron Road
Tauranga
Bay of Plenty
Country [1] 256486 0
New Zealand
Other collaborator category [1] 251363 0
Individual
Name [1] 251363 0
Leo Sheck
Address [1] 251363 0
Waikato Hospital
Pembroke Street
Hamilton 3204
Waikato
Country [1] 251363 0
New Zealand
Other collaborator category [2] 251364 0
Individual
Name [2] 251364 0
Paul Salmon
Address [2] 251364 0
Skin Centre Specialist Dermatologists
171 Cameron Road
Tauranga 3112
Country [2] 251364 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259263 0
Northern Y Ethics Committee
Ethics committee address [1] 259263 0
3rd floor, Bank of New Zealand (BNZ) building
354 Victoria St
PO Box 1031
Hamilton 3204
Ethics committee country [1] 259263 0
New Zealand
Date submitted for ethics approval [1] 259263 0
Approval date [1] 259263 0
31/05/2010
Ethics approval number [1] 259263 0
NTY/10/EXP/024

Summary
Brief summary
In this study, we would like to assess the effect of waiting time on the growth of basal cell carcinomas or BCC's (a type of skin cancer) in the periocular (around the eye) region.

BCCs have traditionally been regarded as slow growing tumours that can take up to 10-15 years to double in size. However, this evidence is anecdotal and based more on self-reported cases rather than comprehensive studies. It is our experience that BCCs in the New Zealand population could double in size at a much faster rate.

We would also like to know if there are any patient-related factors that can predict which cancers will grown more quickly than others. This information could help us triage patients to having earlier surgery and how quickly we send certain patients to have surgery.
Trial website
http://www.skincentre.com/about_us/Leading_the_way_in_Research/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31361 0
Dr Eugene Tan
Address 31361 0
Skin Centre
171 Cameron Road
Tauranga
Bay of Plenty
New Zealand
Country 31361 0
New Zealand
Phone 31361 0
+64-7-5785788
Fax 31361 0
Email 31361 0
[email protected]
Contact person for public queries
Name 14608 0
Dr Stephen Ng
Address 14608 0
Waikato Hospital
Pembroke Street
Hamilton 3204
Waikato
Country 14608 0
New Zealand
Phone 14608 0
+64-7-8398899
Fax 14608 0
Email 14608 0
[email protected]
Contact person for scientific queries
Name 5536 0
Dr Stephen Ng
Address 5536 0
Waikato Hospital
Pembroke Street
Hamilton 3204
Waikato
Country 5536 0
New Zealand
Phone 5536 0
+64-7-8398899
Fax 5536 0
Email 5536 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
SourceTitleYear of PublicationDOI
EmbaseGrowth of periocular basal cell carcinomas.2015https://dx.doi.org/10.1111/bjd.13470
EmbaseA practical decision-tree model to predict complexity of reconstructive surgery after periocular basal cell carcinoma excision.2017https://dx.doi.org/10.1111/jdv.14012
N.B. These documents automatically identified may not have been verified by the study sponsor.