Melanoma Clinical Trial
Official title:
The Impact of Total Body Skin Examination on Skin Cancer Detection
This will be a study where all patients will undergo a two-step procedure:
Step 1 - Physicians examine the problem area of skin ONLY and record result. Step 2 -
Physicians perform TBSE and record result. Eventual lesions suggestive of melanoma and
non-melanoma skin cancers will be recorded after step 1 or step 2 examination and will be
finally biopsied and histopathologically diagnosed. Exceptions to biopsy may include
patients with multiple non-melanoma skin cancers (e.g. actinic keratoses or basal cell
carcinomas).
Each center will be provided with an electronic data sheet for patients record, or
alternatively, with a paper record form.
Endpoints of the study are new parameters concerning the standard of care for skin cancer
screening. We expect to conclude that TBSE enables clinicians discovering an increased
number of skin cancers thus resulting in earlier 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).
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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