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Trial registered on ANZCTR


Registration number
ACTRN12619001584123
Ethics application status
Approved
Date submitted
4/11/2019
Date registered
18/11/2019
Date last updated
4/08/2020
Date data sharing statement initially provided
18/11/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Baker Skin Field Cancerisation Tool: Clinical Validation and Correlation with Quality of Life
Scientific title
Baker Skin Field Cancerisation Tool: Clinical Validation and Correlation with Quality of Life
Secondary ID [1] 299520 0
N/A
Universal Trial Number (UTN)
U1111-1241-7883
Trial acronym
N/A
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Skin Cancer 314770 0
Condition category
Condition code
Cancer 313100 313100 0 0
Non melanoma skin cancer

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study will aim to clinically validate the use of the Baker Skin Field Cancerisation Tool (BSFCT). This tool was developed to assess skin field cancerisation in patients by assigning a score, taking into consideration the degree of cancerisation.

The BSFCT has so far been developed and validated with the use of photographs of patient skin fields, but is yet to be validated in a clinical setting.

The two main aims of this study are:
1. To assess skin field cancerisation in patients in vivo, in the clinic using the BSFCT. The skin fields will then be photographed and the photographs will be scored at a later date using the BSFCT. The correlation between scoring skin fields in vivo and scoring the same fields using photographs will be determined.

2. The correlation of the patients' quality of life outcomes to the score obtained by the BSFCT will be determined by using the DLQI and EQ-5D-5L quality of life instruments.

Additionally, two other tools which have previously been developed by other groups for the assessment of actinic keratoses, the Actinic keratosis field assessment scale (AK-FAS) and the Actinic keratosis area and severity index (AKASI) will be used in this study. These tools will be used in both above aims to score patient skin field cancerisation in vivo in the clinic and on photographs. The purpose of this is to determine how the AK-FAS and AKASI outcomes will ultimately correlate with the outcomes of the BSFCT.

In vivo scoring, obtaining of photographs to be scored at a later date and the completion of the quality of life questionnaires will occur during a single clinic visit. No additional visits or commitments from the participants will be needed.

Two dermatologists will conduct the session and will assess the eligible skin field/s of the participant which presents skin cancerisation. The same fields will then be photographed for assessment by these two dermatologists along with additional scorers. The additional scorers will be provided with the photographs soon after the patient's clinic visit. The dermatologists who scored the skin field in vivo in the clinic will score the photographs 4 weeks following the participant's clinic visit.

The participant will also be provided with the DLQI and EQ-5D-5L quality of life questionnaires to be completed prior to the skin assessment in the clinic. The duration of the visit is expected to last 40 minutes to one hour.
Intervention code [1] 315776 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321641 0
The primary objective of this study is to validate the Baker Skin Field Cancerisation Tool with in-vivo and photographic scoring.
Timepoint [1] 321641 0
In vivo assessment and scoring will occur during the participants' clinic visit. Scoring of the photographs will occur at least four (4) weeks (and no more than 8 weeks) following the clinic visit.
Secondary outcome [1] 375722 0
Correlate the Baker Skin Field Cancerisation Tool score with quality of life measures (DLQI and EQ-5D-5L)
Timepoint [1] 375722 0
Participants' first clinic visit
Secondary outcome [2] 375723 0
Compare Baker Skin Field Cancerisation scores with AK-FAS scores for assessment of the same field
Timepoint [2] 375723 0
Participants' first clinic visit (in vivo scoring) and at least four (4) weeks (and no more than 8 weeks) following the first clinic visit (scoring of photographs)
Secondary outcome [3] 376765 0
Compare Baker Skin Field Cancerisation scores with AKASI scores for assessment of the same field
Timepoint [3] 376765 0
Participants' first clinic visit (in vivo scoring) and at least four (4) weeks (and no more than 8 weeks) following the first clinic visit (scoring of photographs)
Secondary outcome [4] 385283 0
Compare assessor scores between in vivo and photographic scoring
Timepoint [4] 385283 0
8-12 weeks following the clinic visit of the final patient enrolled to the study and the conclusion of the study.
Secondary outcome [5] 385284 0
Compare between in vivo and photographic assessors with photographic only assessors
Timepoint [5] 385284 0
8-12 weeks following the clinic visit of the final patient enrolled to the study and the conclusion of the study.

Eligibility
Key inclusion criteria
• Aged 18 years or older
• Attending St Vincent’s Hospital Melbourne dermatology clinics
• Informed consent for participation obtained
• Evidence of actinic damage in one or more anatomic zone
• Range of severities: no threshold for severity as the study seeks to gain experience in a range of disease presentations.
• All Fitzpatrick skin phototypes.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Less than 18 years of age
• Informed consent for participation not obtained
• No actinic damage

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
All analyses will be conducted using Stata MP2 v 16 or equivalent statistical software.

Primary analysis:

Inter-rater agreement: Inter-rater agreement will be assessed using Cohen’s kappa. Interpretation is designated: less than chance agreement (kappa<0), slight agreement (kappa=0.01–0.20), fair agreement (kappa=0.21–0.40), moderate agreement (kappa= 0.41–0.60), substantial agreement (kappa = 0.61–0.80), and almost perfect agreement (kappa = 0.81–0.99).

Test-retest reliability: Test-retest reliability will be assessed using Cohen’s kappa. Interpretation is designated: The interpretation of reproducibility adopted is: marginal (kappa= 0.00–0.40), good (kappa = 0.40–0.75) and excellent (kappa > 0.75).

Concurrent validity: Validity will be assessed by determining the correlation between the Baker Skin Field Cancerisation score and the AK-FAS score or AKASI score using Pearson’s correlations.

Utility: the time taken to administer the Baker Skin Field Cancerisation score will be summarised descriptively. The ease of administration will be assessed on a Likert Scale (Very easy to administer, easy to administer, difficult to administer or very difficult to administer), and results will be summarised descriptively.

Secondary analysis:

The first secondary objective is to correlate the BSFCT score with QOL measures (DLQI and EQ-5D-5L). Some patients will have multiple fields assessed at different sites, but each patient will only have one set of QOL measures at each timepoint.

The second secondary objective is to correlate BSFCT scores with AK-FAS and AKASI scores for assessment of the same field. Correlations between the BSFCT Score and the AK-FAS total score or AKASI total score will be calculated using Pearsons’ correlation coefficient. Correlations between the BSFCT Global Score and the AK-FAS total score or AKASI total score will also be calculated using Pearsons’ correlation coefficient.

-The QOL scores (DLQI and EQ-5D-5L):
The DLQI will be scored according to its recommended scoring instructions. The EQ-5D- 5L will be scored according to its recommended scoring manual. It should be noted that given the sample size is based on number of fields not number of patients, there will be a smaller number of QOL instrument scores collected.

-Correlation of BSFCT in vivo scores for a single case between assessors
-Correlation of assessors scores between in vivo and photographic scoring
The Bland-Altman test will be used to compare scores given using an in vivo assessment compared to photographic assessment.

-Correlation between in vivo and photographic assessors with photographic only assessors
The Bland-Altman test will be used to compare scores given using an in vivo and photographic assessment compared to photographic assessment.

For the purposes of this study, the number of fields analysed will be used rather than the number of individual patients. Given the purpose of this study is to validate the BSFCT, the potential bias due to correlation between fields is not considered important.

Sample size calculations were performed using Pass 2019.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/09/2020
Actual
Date of last participant enrolment
Anticipated
31/03/2021
Actual
Date of last data collection
Anticipated
31/05/2021
Actual
Sample size
Target
71
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14939 0
St Vincent's Private Hospital - Fitzroy
Recruitment postcode(s) [1] 28214 0
3065 - Fitzroy

Funding & Sponsors
Funding source category [1] 304011 0
Commercial sector/Industry
Name [1] 304011 0
GenesisCare
Country [1] 304011 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
GenesisCare
Address
Buildings 1 & 11, The Mill, 41-43 Bourke Road
Alexandria NSW 2015
Country
Australia
Secondary sponsor category [1] 304188 0
None
Name [1] 304188 0
Address [1] 304188 0
Country [1] 304188 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304505 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 304505 0
Ethics committee country [1] 304505 0
Australia
Date submitted for ethics approval [1] 304505 0
22/10/2019
Approval date [1] 304505 0
28/10/2019
Ethics approval number [1] 304505 0

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

Contacts
Principal investigator
Name 97182 0
A/Prof Chris Baker
Address 97182 0
Department of Dermatology
St Vincent's Hospital
41 Victoria Parade
Fitzroy
VIC 3065
Country 97182 0
Australia
Phone 97182 0
+61 3 9288 3298
Fax 97182 0
Email 97182 0
Chris.Baker@svha.org.au
Contact person for public queries
Name 97183 0
Chris Baker
Address 97183 0
Department of Dermatology
St Vincent's Hospital
41 Victoria Parade
Fitzroy
VIC 3065
Country 97183 0
Australia
Phone 97183 0
+61 3 9288 3298
Fax 97183 0
Email 97183 0
Chris.Baker@svha.org.au
Contact person for scientific queries
Name 97184 0
Chris Baker
Address 97184 0
Department of Dermatology
St Vincent's Hospital
41 Victoria Parade
Fitzroy
VIC 3065
Country 97184 0
Australia
Phone 97184 0
+61 3 9288 3298
Fax 97184 0
Email 97184 0
Chris.Baker@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual raw line-by-line data will be publicly available. The overall findings of this study will be published.


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.