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Validation of Skin Field Cancerisation Index: the assessment of a solar damage severity tool for patients undergoing radiotherapy treatment for field cancerisation.

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12620000056998
Acronym
SCS002
Enrollment
150
Registered
2020-01-23
Start date
2020-02-01
Completion date
2021-02-01
Last updated
2020-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

GenesisCare
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Healthy volunteers
No

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)

Exclusion criteria

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026