The primary aim of the study is the validation of the dermatoscope as a diagnostic aid for analyzing patients who visit the GP with the suspicion of a skin malignancy.Secondary aims of the study are the determination of the extent of health careā¦
ID
Source
Brief title
Condition
- Skin neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measure is the diagnostic accuracy of the dermatoscope as a
diagnostic test analyzing skinmalignancies in general practice.
Secondary outcome
Secondary outcome measures are the sensitivity, specificity, the number of
excisions c.q. biopsies and referrals to secundary care. In a economical
evaluation the costs of the two diagnostic strategies will be analysed.
Background summary
GP's are regulary asked to analyse a pigmented lesion or local swelling
(nodule) of the skin. It is expected that in the future there will be a
increase of skincancer patients in The Netherlands and in other European
countries because of increasing incidence and the aging of the population. In
secundary care the dermatoscope offers an increase in specificity (15%) and
sensitivity (25%) to the diagnostic proces and also gives a decrease of small
surgery. We expect the dermatoscope to give an increase of diagnostic accuracy
in the GP's office.
Study objective
The primary aim of the study is the validation of the dermatoscope as a
diagnostic aid for analyzing patients who visit the GP with the suspicion of a
skin malignancy.
Secondary aims of the study are the determination of the extent of health care
consumption: the number of referrals to secundary care, the number of excisions
send to the pathologist, both compared to the golden standard (clinical
judgement of the dermatologist or the histological diagnosis).
In a economical evaluation the costs of both diagnostic strategies will be
investigated.
The diagnostic accuracy of the dermoscope for pigmented and non-pigmented skin
lesions.
Study design
The design of this study is a diagnostic trial. In which the GP's will be
randomized in stead of patients.
Intervention
In the interventiongroup the dermatoscope will be used after clinical analysis
to analyse the skinlesion and to diagnose this lesion. In the controlgroup the
diagnostic fase will be finished after the clinical analysis without the use of
a dermatoscope.
Study burden and risks
The use of the dermatoscope in the interventiongroup will not give any physical
burden to the patient, as the investigation is non-invasive. The dermatoscope
is already a accepted diagnostic tool in secundary care.
GP's in both groups will get a diagnostic training to optimalize the diagnosis
of patients with skin malignancies, which will be in favour of the patients.
The golden standard for the diagnosis is the judgement of the dermatologist
(based on teledermatology / teledermatoscopy or after referral) or in case of
excision / biopsy the diagnosis of the pathologist. In case the lesion cannot
be judged by teledermatology / teledermatoscopy the patient shall be refered
to a dermatologist. The number of excisions / biopsies is expected to stay the
same in both groups or to decrease by optimalization of the clinical
judgement.
Because of this research, the appointment will take more time than normal,
although it can be done in 1 appointment en the patient won't have to come back
because of this research.
Antonius Deusinglaan 1
Groningen 9700 RB
NL
Antonius Deusinglaan 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
patients are eligible for the study if they are >= 18 years of age, if they have a suspected skinlesion and if they have given informed consent.
Exclusion criteria
Patients will be excluded if they already get a treatment for a skin malignancy, if they have a serious disease or if they cannot be asked to participate in this research (to the opinion of the general practitioner)
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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CCMO | NL30571.042.09 |