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Baker Skin Field Cancerisation Tool: Clinical Validation and Correlation with Quality of Life

Baker Skin Field Cancerisation Tool: Clinical Validation and Correlation with Quality of Life

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12619001584123
Acronym
N/A
Enrollment
71
Registered
2019-11-18
Start date
2020-09-01
Completion date
2021-03-31
Last updated
2020-08-10

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 aims to clinically validate use of the Baker Skin Field Cancerisation Tool (BSFCT) in people attending St Vincent’s Hospital Melbourne dermatology clinic. Who is it for? You may be eligible to join this study if you are aged 18 years or above, are attending St Vincent’s Hospital Melbourne dermatology clinic, and have evidence of actinic damage (i.e. skin damage from ultraviolet exposure). Study details All participants in this study will attend a single [duration of 40 minutes - 1 hour] clinical appointment, administered by dermatologists. The session involves completing two separate questionnaires which will evaluate the quality of your life at the time of the clinic visit, assessment of the area or areas of your body with actinic damage to your skin by the dermatologists and taking photographs of these areas with actinic damage. The skin will be scored during the clinic visit and also later from the photographs using the Baker Skin Field Cancerisation Tool (BSFCT). 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 both the clinic visits and from the photos. Scores from all of these tools will be correlated in order to determine the clinical validity of the BSFCT. It is hoped that this will be found to be a useful tool to assess skin damage.

Interventions

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,

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.

Sponsors

GenesisCare
Lead SponsorCommercial sector/Industry

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

Exclusion criteria

• Less than 18 years of age • Informed consent for participation not obtained • No actinic damage

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026