The Impact of Total Body Skin Examination on Skin Cancer Detection
Clinicans performed a two-step examination for skin cancer, with clinical examination of
individual lesions was aided by the use of dermoscopy, as needed. In the first step,
physicians performed inspection of problem areas and uncovered areas only, and lesions
suggestive of melanoma or non-melanoma skin cancer were noted. In the second step, TBSE was
performed. Following both examinations, lesions suggestive of melanoma or non-melanoma skin
cancer were excised or biopsied. Histopathologic diagnosis was recorded for each of the
biopsied or excised lesions.
Statistical analysis: We calculated absolute risks as the proportion of individuals with the
target disease divided by all individuals at risk. The number needed to examine was
calculated by dividing the individuals at risk by the numbers of individuals with the target
disease. Confidence intervals for proportions were calculated using standard formulas based
on the binomial distribution. Chi square tests were used for comparison of proportions.
Continuous variables are presented as mean and standard deviation (SD) unless otherwise
specified. For univariate and multivariate analyses we used odds ratios derived from
logistic regression to estimate relative risks and their confidence intervals. All p-values
reported are 2-tailed. Statistical significance is defined as P <0.05. Statistical analysis
was performed using SPSS software, version 16.0 (SPSS, Chicago, Ill, US).
Interventional
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Number of Participants With Suspicious Tumors Detected After Inspection of Problem Area and Inspection of the Full Body.
one year
No
Rainer Hofmann-Wellenhof, Prof.
Principal Investigator
Medical University of Graz-Austria
Austria: Ethikkommission
19-175 ex 07/08
NCT00765193
May 2008
May 2009
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