Condition category
Cancer
Date applied
24/10/2011
Date assigned
07/11/2011
Last edited
05/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Contact information

Type

Scientific

Primary contact

Mr Nick van der Beek

ORCID ID

Contact details

Hoge Naarderweg 7 H
Hilversum
1217AB
Netherlands

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

http://www.zbcmulticare.nl

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

Publication citations

Additional files

Editorial Notes