The Impact of Total Body Skin Examination on Skin Cancer Detection
Condition: Melanoma; Basal Cell Carcinoma; Squamous Cell Carcinoma; Merkel Cell Carcinoma; Skin Cancer
MeSH terms: Carcinoma, Merkel Cell; Carcinoma; Carcinoma, Basal Cell; Skin Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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).
    

Intervention name(s): Inspection of covered areas
Intervention type(s): Other
Intervention description(s): 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.
Other intervention name(s): Inspection of problem areas
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic