ANZCTR - Registration

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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]

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.

Condition category

Condition code

Skin

Other skin conditions

Cancer

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]

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]

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]

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]

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]

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?

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]

New Zealand

State/province [1]

Waikato

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Waikato Hospital

Address [1]

Pembroke Street
Hamilton 3204
Waikato

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Stephen Ng

Address

Waikato Hospital
Pembroke Street
Hamilton 3204
Waikato

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Eugene Tan

Address [1]

Skin Centre
171 Cameron Road
Tauranga
Bay of Plenty

Country [1]

New Zealand

Other collaborator category [1]

Individual

Name [1]

Leo Sheck

Address [1]

Waikato Hospital
Pembroke Street
Hamilton 3204
Waikato

Country [1]

New Zealand

Other collaborator category [2]

Individual

Name [2]

Paul Salmon

Address [2]

Skin Centre Specialist Dermatologists
171 Cameron Road
Tauranga 3112

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Northern Y Ethics Committee

Ethics committee address [1]

3rd floor, Bank of New Zealand (BNZ) building
354 Victoria St
PO Box 1031
Hamilton 3204

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

31/05/2010

Ethics approval number [1]

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

Dr Eugene Tan

Address

Skin Centre
171 Cameron Road
Tauranga
Bay of Plenty
New Zealand

Country

New Zealand

Phone

+64-7-5785788

Fax

[email protected]

Contact person for public queries

Name

Stephen Ng

Address

Waikato Hospital
Pembroke Street
Hamilton 3204
Waikato

Country

New Zealand

Phone

+64-7-8398899

Fax

[email protected]

Contact person for scientific queries

Name

Stephen Ng

Address

Waikato Hospital
Pembroke Street
Hamilton 3204
Waikato

Country

New Zealand

Phone

+64-7-8398899

Fax

[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

Source	Title	Year of Publication	DOI
Embase	Growth of periocular basal cell carcinomas.	2015	https://dx.doi.org/10.1111/bjd.13470
Embase	A practical decision-tree model to predict complexity of reconstructive surgery after periocular basal cell carcinoma excision.	2017	https://dx.doi.org/10.1111/jdv.14012

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically