Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001513202
Ethics application status
Approved
Date submitted
4/06/2018
Date registered
10/09/2018
Date last updated
29/09/2020
Date data sharing statement initially provided
29/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Trial of a deep laser technique to prevent skin cancers in people with a strong history of them.
Scientific title
Trial of laser resurfacing to target mutation load in people with a strong history of skin cancers.
Secondary ID [1] 293557 0
Nil known
Universal Trial Number (UTN)
U1111-1206-0074
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Epidermal carcinoma 305783 0
Condition category
Condition code
Cancer 304999 304999 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Study participants aged 45 years or older with a history of more than 10 epidermal carcinomas will be considered. Patients will be excluded if they have used field therapy such as topical fluorouracil, photodynamic therapy, ingenol or imiquimod on the areas considered for treatment in the past 6 months; if they have had an organ transplantation or are on immunosuppressive therapy; if they have an active blood borne disease (e.g. HIV) or have a hereditary genetic condition favoring a skin cancer.
Dorsal forearms are used as they are often severely sun-exposed areas. ND-YAG ablative laser resurfacing will be conducted on the identified area under local anesthesia in the department of dermatology at the Princess Alexandra Hospital, Brisbane, by a dermatological surgeon. This method is preferred to dermabrasion as it is easier to control the depth and has a greater safety profile.
Laser parameters include: wavelength of 2940nm, frequency of 8hz, 4-6 passes at different depths (equivalent to a depth of ablation 400 microns and 600 microns), overlap of 50%, dose is 25J/cm2 per pass. There is no cooling.
In consenting patients and using a marker pen, three areas of skin, each measuring 25mm x 25mm (about the size of a ten cent piece) will be selected. These regions will not have any skin cancers on them. Two of these areas will be resurfaced and one will act as a control area.
Two of the areas will then be injected with local anaesthetic. When the skin is numb both areas will be lasered, one to a depth of 0.4mm and the other to 0.6mm. This compares to the thickness of 1-2 business cards. This ‘resurfacing’ will remove the sun-damaged skin layers.
The third area will not be treated and will be used as a control area.
After 3 months, 2mm (diameter) biopsies will be taken from the resurfaced and the control areas. A saliva specimen will be used for reference genomic DNA. Whole exome sequencing will be conducted at 500X depth.
Intervention code [1] 301308 0
Treatment: Surgery
Comparator / control treatment
One area of skin (adjacent to the 2 areas that have been treated by epidermal ablation) will act as a control. This control area will be as close as possible to the treated areas on the forearm and will be the same size as these areas: 25 x 25mm. At the 3-month mark, biopsies of both treated areas and the one adjacent untreated area of skin will be biopsied and compared.
Control group
Active

Outcomes
Primary outcome [1] 306083 0
Primary outcome will be the differences in mutation load in the 3 skin biopsies taken at the 3-month timepoint.
There will one biopsy from each of the two treated areas and one from the single control area.
Whole exome sequencing will be used. The mutation loads in the exome from the three samples will be compared.
Timepoint [1] 306083 0
3 months post-ablation.
Primary outcome [2] 306084 0
A second and composite primary outcome will be to compare in detail any UVB versus UVA (oxidative stress) induced mutations from each of the 3 biopsied areas (the two treated areas and the single control area).
Whole exome sequencing will be used.
Timepoint [2] 306084 0
3 months post-ablation.
Secondary outcome [1] 347521 0
A secondary outcome is scarring.
This will be assessed by digital photography.
Timepoint [1] 347521 0
Scarring will be assessed at a single timepoint of 3 months post-ablation.
Secondary outcome [2] 347641 0
A secondary outcome is hypopigmentation.
This will be assessed by digital photography.
Timepoint [2] 347641 0
Hypopigmentation will be assessed at a single timepoint of 3 months post-ablation.

Eligibility
Key inclusion criteria
Participants must: have had more than 10 skin cancers such as BCC (basal cell carcinoma) or SCC (squamous cell carcinoma).
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*having had forearms treated with topical fluorouracil (e.g.Efudix) or photodynamic therapy or ingenol (Picato) or imiquimod (Aldara) in the last 6 months
*having had an organ transplantation or be on immunosuppressive therapy
*having any active blood borne diseases (e.g. HIV, HBV, HCV)
*having a hereditary genetic condition favoring a skin cancer

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Patients act as their own control. For each patient, and on the same forearm that receives epidermal ablation, one area is left untreated and used as a 'control'. Final biopsies of both treated and control skin patches will compare mutation load.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using a paired t test, assuming normal distribution of data and a standard deviation twice the lowest frequency of mutations, 14 patients are needed to reach a significance level of 0.01 with a power of 90% to observe a four-fold decline in mutation frequency.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
23/03/2019
Date of last participant enrolment
Anticipated
31/05/2019
Actual
9/05/2019
Date of last data collection
Anticipated
30/09/2019
Actual
17/07/2019
Sample size
Target
14
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 11042 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 22838 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 298105 0
Government body
Name [1] 298105 0
NHMRC (National Health and Medical Research Council).
Country [1] 298105 0
Australia
Primary sponsor type
University
Name
University of Queensland Diamantina Institute
Address
Level 6
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 298951 0
Government body
Name [1] 298951 0
Metro South Health
Address [1] 298951 0
Centres for Health Research
Level 7, Translational Research Institute
37 Kent Street
Woolloongabba QLD 4102
Country [1] 298951 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299125 0
Metro South HREC
Ethics committee address [1] 299125 0
Ethics committee country [1] 299125 0
Australia
Date submitted for ethics approval [1] 299125 0
16/11/2017
Approval date [1] 299125 0
23/01/2018
Ethics approval number [1] 299125 0
HREC/17/QPAH/823

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79382 0
Prof Kiarash Khosrotehrani
Address 79382 0
UQDI
Level 6
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4120
Country 79382 0
Australia
Phone 79382 0
+61 7 34437088
Fax 79382 0
+61 7 3443 6966
Email 79382 0
[email protected]
Contact person for public queries
Name 79383 0
Kiarash Khosrotehrani
Address 79383 0
UQDI
Level 6
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4120
Country 79383 0
Australia
Phone 79383 0
+61 7 34437088
Fax 79383 0
+61 7 3443 6966
Email 79383 0
[email protected]
Contact person for scientific queries
Name 79384 0
Kiarash Khosrotehrani
Address 79384 0
UQDI
Level 6
Translational Research Institute
37 Kent Street
Woolloongabba QLD 4120
Country 79384 0
Australia
Phone 79384 0
+61 7 34437088
Fax 79384 0
+61 7 3443 6966
Email 79384 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results.
When will data be available (start and end dates)?
Beginning 3 months following publication with no end date determined.
Available to whom?
Case-by-case basis at the discretion of Professor Kiarash Khosrotehrani from UQ.
Available for what types of analyses?
Only to achieve the aims of the study and for metaanalysis
How or where can data be obtained?
Data will be on online repository of genomics data as specified in future publications.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9327Study protocol  [email protected]
9328Informed consent form  [email protected]



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.