Plain English Summary
Background and study aims:
Non melanoma skin cancer (NMSC) is the most common form of skin cancer and has been shown to affect more than one in six in a population of Caucasian males in the north of England. Although the risk of spreading to other organs and loss of life is relatively low compared to melanoma skin cancer, lesions of NMSC need to be removed as they will otherwise keep on growing unchecked. Early treatment prevents avoidable deaths and complications and treatment of less progressed lesions usually is less burdensome to the patient and can avoid repeated treatments.
The problem which limits the number of lesions treated at an early stage is that the condition does not have any symptoms. That is, early lesions do not itch, present little or no scaling or redness and are difficult to notice. As a result, many lesions of NMSC go unnoticed by the patient or GP.
There is a new method for identifying NMSC called fluorescence detection. Fluorescence is phenomenon that some compounds emit light (i.e. glow) when they are illuminated with a certain kind of light. Some compounds are either more or less prominent in NMSC fluoresce, which can be used to identify NMSC, i.e. detect them based on their fluorescence properties.
In this study we us a compound called 5-aminolevulinic acid (5-ALA) which is applied to the skin and after the application, one can find the NMSC by looking for those areas of the skin that show relatively high levels of fluorescence. This should allow a specialist to be able to find NMSC before they are visible to the naked eye. This study aims to find out if fluorescence detection is more accurate than the traditional clinical inspection at finding NMSC.
Who can participate?
Any person being suspected of having a NMSC with Fitzpatrick skin type I, II or III.
What does the study involve?
Participants have a standardized clinical inspection. A trained doctor examines the skin in a systematic manner in order to find symptoms associated with NMSC. During the examination the doctor looks at your skin to see if there are any reddish lesions, or if there is some scaling. In addition, the doctor feels if there are some irregularities such as scaling or bumps. Every time the doctor finds an area that might contain a NMSC, it is noted on a form for later investigation. Following the inspection, fluorescence detection is performed. This consists of the application of a spray containing 0.5% 5-aminolevulinic acid for 2.5 hours, following which fluorescence measurements are performed with a specially developed camera and system. Those areas which based on the fluorescence detection or the clinical inspection are deemed to be suspicious of containing a NMSC are further investigated, identified and if necessary treated.
What are the possible benefits and risks of participating?
Benefits of the study include identifying NMSC earlier so that patients can be treated earlier. There is a risk of some minor irritation of the skin (some red spots and some swelling) if it is exposed to intense sunlight after the investigation, which can last for three hours. The spray used in this study contains fats. As a result, skin will be a bit greasy. Participants will need to have a shower or take a bath before going to bed, otherwise some minor skin irritation can occur. If the skin gets irritated then there is no need for concern. The symptoms will disappear within a week without further treatment.
Where is the study run from?
ZBC Multicare, the Netherlands
When is study starting and how long is it expected to run for?
The study started in late 2011 and ended in early 2012.
Who is funding the project?
ZBC Multicare
Who is the main contact?
Nick van der Beek
nick.vanderbeek@zbcmulticare.nl
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MC 2011/10
Study information
Scientific title
Observer blinded intra-patient direct comparison of the accuracy of classical method and auto-fluorescence normalized liposomal encapsulated 5-aminolevulinic acid induced protoporphyrin IX (PpIX) fluorescence detection method of detecting non-melanoma skin cancer
Acronym
Study hypothesis
Auto-fluorescence normalized liposomal encapsulated 5-aminolevulinic acid induced protoporphyrin IX fluorescence detection has a higher sensitivity and specificity than 10 minute visual inspection and palpation in a general clinical setting when detecting non-melanoma skin cancers (NMSC)
As of 04/01/2012, anticipated end date of trial was corrected from 31/01/2012 to 03/01/2012.
Ethics approval
ZBC Multicare Medical Ethical Committee, 28 September 2011, ref: 20011/10
Study design
Prospective observer blinded intra-patient direct comparison study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Non-melanoma skin cancer
Intervention
Visual inspection and palpation for the detection of non-melanoma skin cancer versus auto-fluorescence normalized liposomal encapsulated 5-aminolevulinic induced protoporphyrin IX fluorescence detection of non-melanoma skin cancer
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. False positives, false negatives, true positives and true negatives are recorded for both methods
2. The true and false negatives are calculated using the combined locations of true and false positives of both methods. Based on these sensitivity and specificity of both methods are calculated.
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/11/2011
Overall trial end date
03/01/2012
Reason abandoned
Eligibility
Participant inclusion criteria
1. Male and female aged 40 and over
2. History of NMSC
3. Being referred to a dermatologist for a NMSC check-up
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
30
Participant exclusion criteria
1. Use of a peeling agent
2. Use of 5-fluorouracil (5-FU)
3. Skin type IV or higher
4. Skin type III with tanning less than two months prior to the participation
5. Recent tanning
6. Porphyria
7. Epilepsy
8. Inflammatory disease (e.g. psoriasis, acne)
9. Excessive hair on chest or face
Recruitment start date
01/11/2011
Recruitment end date
03/01/2012
Locations
Countries of recruitment
Netherlands
Trial participating centre
Hoge Naarderweg 7 H
Hilversum
1217AB
Netherlands
Sponsor information
Organisation
ZBC Multicare (Netherlands)
Sponsor details
High Naarderweg 7H
Hilversum
1217AB
Netherlands
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
ZBC Multicare (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary