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Trial registered on ANZCTR


Registration number
ACTRN12620000056998
Ethics application status
Approved
Date submitted
21/11/2018
Date registered
23/01/2020
Date last updated
23/01/2020
Date data sharing statement initially provided
23/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Validation of Skin Field Cancerisation Index: the assessment of a solar damage severity tool for patients undergoing radiotherapy treatment for field cancerisation.
Scientific title
A multi-centre, multi-specialty collaboration for creating a consistent valid scoring tool using patient skin field photographs for tumour severity and extent assessment of skin field cancerisation
Secondary ID [1] 296672 0
None
Universal Trial Number (UTN)
Trial acronym
SCS002
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Skin Cancer including Keratinocyte Carcinomas 310512 0
Condition category
Condition code
Skin 309227 309227 0 0
Dermatological conditions
Cancer 312102 312102 0 0
Malignant melanoma
Cancer 312103 312103 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
Non-interventional study design to validate a skin field cancerisation index score. De-identified photographs of skin fields will be assessed by panel members to validate a severity score. There is no active patient participation involved.

This is a multi-site and multi-specialty initiative lead by Dermatologists with the primary outcome aim of validating the Skin Field Cancerisation Index (SFCI). Patient photography will be the primary method of data collection used for validating this score in line with previous skin indices. Twenty specialists around Australia will assess up to 150 photographs to measure their perceptions of SFCI which will be statistically analysed using SPSS software to identify reliability and validity of the instrument. Investigators who will be scoring include Fellows of the Australasian College of Dermatologists, Fellows of the Royal Australian and New Zealand College of Radiologists and Registered Nurses all with a special interest in dermatoses. Skin Fields that will be collected range from none to severe tumour severity based on previous dermatological experience.

Skin field cancerisation is defined as: areas of solar damage involving multiple actinic keratoses (AKs), the clinical signs of photo-ageing, and variable numbers and types of melanoma and non melanoma skin cancers. This index scores a range of skin field cancerisation severities, one of which is extensive field cancerisation. extensive field cancerisation is classified as areas of involvement greater that 50cm2 or difficult to treat areas such as the nose.

The skin field cancerisation index is clinical tool which assesses a range of factors that contribute to skin field cancerisation severity. There are three sub-scores within the score including:
1) Number of Actinic Keratoses, Thickness of keratoses, and clinical evidence of atypical keratoses (Bowenoid) & skin cancer (SCC/BCC)
2) Area of involvement
3) Global Assessment score
resulting in a total score of the three sub-scores.

These scores are calculated by assessment of the characteristics of change compared normal skin as observed in the clinical photographs.

The observations are conducted between July and September 2019. Photographs are selected based off the following inclusion criteria:
Photographs were selected based off the following Inclusion criteria:
• Treatable region of Skin Field Cancerisation in the following regional areas:
o Scalp
o Forehead
o Nose
o Cheek (one)
o Ear (one)
o Forearm (one)
o Back of Hand (one)
o Lower leg (one)
o Top of foot (one)
o Chest
• Photographs of participants over 18 years of age

Exclusion Criteria:
• Poor quality photographs
• Other dermatoses effecting assessment (e.g. inflammatory skin diseases) that may confuse scorers

In order to validate the SFCI a non-interventionist data collection approach will be conduced to collect pre-existing photography from dermatologist’s patient libraries. Retrospective photography will be collected from dermatologists existing medical records. The photographs are collected based on the pre-defined regions of skin field cancerisation and screened based on the above inclusion criteria. The clinical scoring phases (including the Delphi) of this study are conducted prospectively.

De-identified photography will be used in the study in accordance with the Australian Privacy Principals Guidelines Act 1988. All imaging will remove eye features and other distinguishing skin markings that could be used to identify participants. Imaging is part of standard clinical care.
Intervention code [1] 312984 0
Not applicable
Comparator / control treatment
Photographs would be considered the comparator/control/reference standard
Control group
Active

Outcomes
Primary outcome [1] 308196 0
Valid Skin Field Cancerisation Score:

For the creation of the score including confirming the relevant items, a Delphi method will be used to determine the most important attributes of field cancerisation. This technique has been chosen as it is specifically useful when there is no pre-existing score for comparison of existing items. The items that make up field cancerisation are not explicitly available from existing literature therefore, it was determined that a Delphi method would be useful for collating the opinions from a panel of experts as to what should be included. This process did not use photography, but, involved a collaborative contribution of the panel to rank the relevant items that will make up the scale. The Delphi method was deemed appropriate as a replacement for a statistical measure of principal components analysis as the opinions of the experts was sufficient.

The SFCI validation process will involve a 3-phase scale development approach to be conducted between October and September 2019. An expert panel of six board certified dermatologists, FACD, from 5 Australian States (Qld (n=2), Vic (n=1), NSW (n=1) and WA (n=1) and one research coordinator will be involved in the initial development of the SFCI. Perceived important criteria for assessing tumour burden will be identified by the group and standard measurements using a Likert type scale to measure severity will be agreed upon. Total scale and algorithms will be discussed by the group to determine the most likely criteria that would appropriately represent tumour burden based on the clinical and research experience of the group.

The second phase (pilot) will involve the collection of 10 photographic images retrieved from the Principal Investigator’s patient database that meet the inclusion criteria between November, 2018 and June, 2019. Photos were de-identified and distributed in a slide format to the group to test the usefulness and the practicality of the scoring instrument. Following the collaboration of the scores, further discussions and amendments will be made, based on the descriptive findings of the panel. As a result of this process the instrument will be developed.

The third phase of the study, will score’s reliability, a combination of a Cronbach's alpha score (for internal consistency) and Kendall's coefficient of concordance, W (for inter-rater reliability) of the photographs. We have chosen these scores as they will enable the reliability of the score to be measured appropriately. During the meeting of the panel members, up to 150 cards will be disseminated with individual scoring sheets and the panel will individually make an assessment. From here, scores will be entered into SPSS and will be analysed at a later date.

This third phase of the process will involve the distribution of the same 30 photographic images to six board certified radiation oncologists from 4 States in Australia (Qld (n=1), NSW (n=2), Vic (n=1) SA (n=1) along with the instrument. Additionally input from radiotherapy nurses who were nominated by the Radiation Oncologists were included to asses the internal consistency amongst these assessors. Results will be collated in a similar process to the first phase and discussions to refine the instrument and identify key differences in anecdotal scoring trends will be made.

Once the score and instrument description process is ultimately refined, an in-person meeting will be held with a panel of the same specialists. Another 30 new images will be collected from panel members’ medical records and de-identified to conceal the privacy of the patients. Consecutive (Quota) sampling technique will be used to reduce bias in the selection of photographs used for scores. All eligible images will be included in the scoring.

An initial training card for the SFCI instrument will be discussed with the group prior to testing and panel members will be given an opportunity to ask questions prior to commencement and throughout the meeting which will be answered in a group discussion.

The panel will be selected for maximum variance for experts in multiple locations in Australia. Instead of finding the statistical mean of individual scores, the structured communication technique will be as follows:
1. Panel members individually score the photograph
2. The scores are handed in to the researcher de-identified
3. The results of the scores will be revealed to the group.
4. A group discussion with the panel will take place regarding the group’s scores.
5. There is then an opportunity for individuals to revise their score.

Respondent’s scores will remain anonymous to other panel members but not to the researcher. This is achieved through the score card’s being handed a data collection team who will summarise scores and de-identify respondents before discussion with the group.

The statistical package SPSS will be used for analysis of the responses and the verification of the scoring system with initial analysis taking place both at the time of the process and formally after the scores are collated.
Timepoint [1] 308196 0
This is a cross sectional study design.
A pilot study has been c0nducted to ensure that the skin score is practical to use for physicians.
Photography will be assessed between July and September, 2019.
There are no visit schedule for patients as they are not directly involved in the scores development.
Secondary outcome [1] 372733 0
Measure consistency between scorer groups through inter-rater agreement using Gwet’s AC. (dermatologists, radiation oncologists and oncology nurses).
Timepoint [1] 372733 0
Scoring conducted between July and December, 2019

Eligibility
Key inclusion criteria

1. Treatable region of Skin Field Cancerisation in at least one of the following regional areas:
o Scalp
o Forehead
o Nose
o Cheek (one)
o Ear (one)
o Forearm (one)
o Back of Hand (one)
o Lower leg (one)
o Top of foot (one)
o Chest (Decolletage)
o Torso (or front or back)

2. De-identified - Photographs of participants over 18 years of age. Photographs will be collected only from two sites from patients who attended clinics .These two sites are QIDerm in Brisbane and St Vincent's Hospital in Melbourne.

The images will have sufficient protection to protect patient privacy. Only areas that are considered inherently non-identifiable i.e., forearms, lower legs, chest and scalp are included. Any other sites will have blackouts of the eyes and other identifying features. All photos will be de-identified before being added to the study and there will be no photos with identifying tattoos or distinctive markings. This process is being used to protect the privacy of the participants and for the fact that identifiable markings will interfere with the scoring system. De-identified photography will be used in the study in accordance with the Australian Privacy Principals Guidelines Act 1988. All imaging will remove eye features and other distinguishing skin markings that could be used to identify participants. Imaging is part of standard clinical care and consent for taking these images is part of the general dermatologist’s practice consent process (Please see consent forms for the QIDerm and Dr Baker’s practice)
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Poor quality photographs;
• Other dermatoses effecting assessment (e.g. inflammatory
skin diseases) that may confuse scorers.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
Internal validity and inter-rater reliability using Cronbach's alpha and Cohen's kappa coefficients methods. Confirmatory Factor Analysis. To measure the score’s reliability, a combination of a Cronbach alpha score (for internal consistency) and Kendall's coefficient of concordance, W (for inter-rater reliability) of the photographs. We have chosen these scores as they will enable the reliability of the score to be measured appropriately. During the meeting of the panel members, up to 150 cards will be disseminated with individual scoring sheets and each panel member will individually make an assessment. From here, scores will be entered into SPSS and will be analysed at a later date.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2020
Actual
Date of last participant enrolment
Anticipated
1/02/2021
Actual
Date of last data collection
Anticipated
1/02/2021
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 14238 0
St Vincent's Private Hospital - Fitzroy
Recruitment hospital [2] 15626 0
QIDerm - South Brisbane
Recruitment postcode(s) [1] 27231 0
3065 - Fitzroy
Recruitment postcode(s) [2] 29028 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 301250 0
Commercial sector/Industry
Name [1] 301250 0
GenesisCare
Country [1] 301250 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
GenesisCare
Address
Building 1 & 11 The Mill, 41-42 Bourke Road
Alexandria
Sydney NSW 2015
Country
Australia
Secondary sponsor category [1] 304855 0
None
Name [1] 304855 0
Address [1] 304855 0
Country [1] 304855 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301988 0
Bellberry Human Ethics Committee
Ethics committee address [1] 301988 0
129 Glen Osmond Road
Eastwood
SA 5063
Ethics committee country [1] 301988 0
Australia
Date submitted for ethics approval [1] 301988 0
26/09/2018
Approval date [1] 301988 0
14/11/2018
Ethics approval number [1] 301988 0
2018-09-793

Summary
Brief summary
This study will develop the Skin Field Cancerisation Index (SFCI) using a Delphi method of experts who assess skin field photographs.

Who is it for?
You may be eligible to join this study if you are aged 18 years or above and have photographs of skin fields including the face, upper limbs, lower limbs and torso.

Study details
This is a multi-site and multi-specialty initiative lead by Dermatologists with the primary outcome aim of validating the Skin Field Cancerisation Index (SFCI). Patient photography will be the primary method of data collection used for validating this score. Skin Fields that will be collected range from none to severe disease burden severity based on previous dermatological experience. Twenty medical specialists around Australia will assess up to 150 photographs to measure their perceptions of SFCI to identify reliability and validity of the instrument.

This study will contribute to research in health care as the use of this score will provide consistency between observers and can potentially be used to assess efficacy of treatment interventions.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88778 0
A/Prof Chris Baker
Address 88778 0
St Vincent’s Hospital Melbourne 41 Victoria Parade Fitzroy VIC 3065
Country 88778 0
Australia
Phone 88778 0
+613 9879 6800
Fax 88778 0
Email 88778 0
[email protected]
Contact person for public queries
Name 88779 0
Chris Baker
Address 88779 0
St Vincent’s Hospital Melbourne 41 Victoria Parade Fitzroy VIC 3065
Country 88779 0
Australia
Phone 88779 0
+613 9879 6800
Fax 88779 0
Email 88779 0
[email protected]
Contact person for scientific queries
Name 88780 0
Chris Baker
Address 88780 0
St Vincent’s Hospital Melbourne 41 Victoria Parade Fitzroy VIC 3065
Country 88780 0
Australia
Phone 88780 0
+613 9879 6800
Fax 88780 0
Email 88780 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?
De-identified data may be shared to authors who wish to report on outcomes of the NDROR through a formal request process. The requested de-identified data points that are relevant to the primary and secondary aims of the proposed study will be made available to the Authors once approval by the NDROR Research Committee has been granted.
When will data be available (start and end dates)?
Data will be made available upon request for the duration of the approved study purposes. This will be negotiated on a case-by-case basis depending on study design requirements. Data will be available from September, 2019. There is no anticipated end date for this availability.
Available to whom?
Only researchers who provide a methodologically sound proposal, case-by-case basis at the discretion of the NDROR Research Committee.
Available for what types of analyses?
Any purpose, only to achieve the aims in the approved proposal, quantitative registry data is collected and available for analysis.
How or where can data be obtained?
Access subject to approvals by The NDROR Research Committee (please email [email protected] for details of the submission process).


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
EmbaseMethod of Assessing Skin Cancerization and KeratosesTM (MASCKTM): development and photographic validation in multiple anatomical sites of a novel assessment tool intended for clinical evaluation of patients with extensive skin field cancerization.2022https://dx.doi.org/10.1111/ced.15136
N.B. These documents automatically identified may not have been verified by the study sponsor.