|- candidate number||8050|
|- NTR Number||NTR2319|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-mei-2010|
|- Secondary IDs||80-81000-98-117 ZonMW|
|- Public Title||Dermatoscopy in general practice. |
|- Scientific Title||Optimalisation of the diagnosis of patients with skin malignancies in general practice by using the dermatoscope.|
|- hypothesis||We expect the dermatoscope to give an increase in diagnostic accuracy in general practice.|
|- Healt Condition(s) or Problem(s) studied||Basal cell carcinoma, Melanoma, Skin cancer|
|- Inclusion criteria||Patients are eligible for the study if they are 18 years of age or older, if they have a suspected skinlesion and if they have given informed consent.|
|- Exclusion criteria||Patients will be excluded if they already had 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).|
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-dec-2009|
|- planned closingdate||1-dec-2011|
|- Target number of participants||476|
|- Interventions||In the interventrion group the dermatoscope will be used after normal clinical evaluation in order to diagnose and evaluate the lesion. In the controlgroup the evaluation of the skin lesion ends after normal clinical evaluation, without the use of the dermatoscope.|
|- Primary outcome||The primary outcome is the diagnostic accuracy of the dermatoscope as diagnostic test for the evaluation of skinlesions. |
|- Secondary outcome||Secondary outcome measures are: |
3. The number of excisions/biopsies;
4. The number of referrals to secondary care;
5. The costs of both diagnostical strategies will be examined.
|- Timepoints||Patients will be included for 1 year.|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Drs. C.J.L. Koelink|
|- CONTACT for SCIENTIFIC QUERIES||Dr. W.K. Heide, van der|
|- Sponsor/Initiator ||University Medical Center Groningen (UMCG)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Background of the study:|
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.
Objective of the study:
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. Secundary aim of the study is 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 design of this study is a diagnostic trial. In which the GP's will be randomized in stead of patients.
The source populations consists of patients aged 18 years or older, who visit the GP because of a skin lesion for which they have not consulted their GP before. Also the GP is uncertain of a benign diagnosis.
In the intervention group the dermatoscope will be used after clinical analysis to analyse the skinlesion and to diagnose this lesion. In the control group the diagnostic fase will be finished after the clinical analysis without the use of a dermatoscope.
The primary outcome measure is the diagnostic accuracy of the dermatoscope as a diagnostic test analyzing skinmalignancies in general practice. 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.
|- Main changes (audit trail)|
|- RECORD||10-mei-2010 - 23-mei-2010|